Quantcast

Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
September 21, 2014, 04:46:28 AM

Login with username, password and session length


Members
  • Total Members: 23510
  • Latest: yuanti
Stats
  • Total Posts: 639624
  • Total Topics: 48549
  • Online Today: 210
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online
Users: 4
Guests: 119
Total: 123

Welcome


Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial  (Read 13417 times)

0 Members and 1 Guest are viewing this topic.

Offline rickbc

  • Member
  • Posts: 8
Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
Main Category: HIV / AIDS News
Article Date: 04 Nov 2007 - 0:00 PDT



Visitor Ratings:

Healthcare Professional:   5 stars
General Public:                     
not yet rated

>> rate this article


GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based biotechnology company, announced today excellent safety and immunogenicity data from its full-dose HIV/AIDS vaccine human trial which began in September 2006.

This full-dose trial is the second in a series of four Phase 1 human trials designed to test the safety and immunogenicity of the GeoVax HIV/AIDS vaccines. Involving 36 participants of which 30 received vaccine and 6 received placebo, this trial protocol included vaccination with two full-doses of GeoVax's DNA vaccine to prime the immune response followed by two full- doses of GeoVax's MVA vaccine to boost the immune response. GeoVax's DNA and MVA vaccines express over 50% of the AIDS virus (HIV-1) protein components in order to stimulate a broad anti-HIV immune response. The vaccines cannot cause AIDS because they do not include complete virus. A Phase 1 human trial, started in April 2006, evaluated the delivery of only 1/10th of the full dosage and utilized the same vaccine regimen evaluated in the full dose trial.

From data collected from the 26 participants who completed the trial, the following positive conclusions were observed:

-- GeoVax HIV/AIDS vaccines, both DNA and MVA, continue to demonstrate that they are quite safe and immunogenic following the delivery of the four full-doses (two of each vaccine) used in the trial's protocol

-- The full-dose regimen of GeoVax vaccines continues to be well tolerated without any type of reaction, mild or systemic, in the majority of participants

-- CD4 T-cell and CD8 T-cell responses are very evident both in the 1/10th dose and full-dose vaccine recipients

-- Antibody responses to the envelope glycoprotein (Env) increased following the fourth vaccination, and were present in 88% of the full-dose participants

-- Delivery of the fourth vaccination increased the frequency and magnitude of the CD8 T-cell and Antibody responses

Two additional Phase 1 human trials testing different vaccine regimens started in June 2007 and are currently in process. Planning of a large Phase 2 trial is underway and tentatively scheduled for a mid-2008 start.

"These results extend the earlier positive results for both our full and 1/10th dose groups to a larger number of volunteers," says Dr. Harriet Robinson, GeoVax Chief Scientific Advisor. "They are extremely encouraging and provide a strong foundation for proceeding with phase 2 human testing."

The human trials, testing GeoVax's HIV/AIDS vaccines, are conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded and supported by the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines. Preclinical work enabling the development of the clinical evaluation of GeoVax's DNA and MVA vaccines was funded by the National Institute of Allergy and Infectious Diseases of the US National Institute of Health. The NIH recently provided additional support to GeoVax's vaccine development program in the form of a $15 million IPCAVD grant awarded in October 2007.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's vaccine technology is protected by 20 filed patent applications and issued patents.

GeoVax HIV/AIDS vaccines are designed to prevent development of Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, by vaccinating individuals prior to infection with the AIDS virus. In addition, GeoVax AIDS vaccines may be effective as therapeutics (treatment of people infected with AIDS virus). Studies evaluating these vaccines in already HIV/AIDS infected individuals are being planned.

GeoVax DNA and Recombinant MVA HIV/AIDS vaccines:

-- Use DNA vaccines to "prime" immune responses and MVA vaccines to "boost" immune responses against the AIDS virus

-- Vaccinate against more than 50% of AIDS virus components and cannot cause AIDS

-- Protected 22 of 23 (96%) non-human primates against the development of AIDS for over 3 1/2 years

-- Are manufactured & tested under GMP/GLP - EMEA (EU) and FDA guidelines

-- Satisfactorily completed earlier DNA HIV/AIDS vaccine Phase 1 human trial

-- Are currently being tested in 4 Human Trials. Two started in 2006, two in summer 2007

-- Have been demonstrated safe to date in human trials

-- Are demonstrating positive immune responses against HIV in the majority of vaccine recipients

-- Are in planning stage for a larger Phase 2 human trial in 2008

For further information visit http://www.geovax.com.

Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward- looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Company's Securities and Exchange Commission filings and report.
What doesn't kill you makes you stronger

Offline Customer

  • Member
  • Posts: 98
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #1 on: November 04, 2007, 06:35:32 PM »
This GeoVax -vaccine seems to be a deactivated virus which injects its junk-genetic matrial into the T-cell, and that somehow protects the T-cell. It counds similar to Virxsys:

VIRXSYS

http://www.genengnews.com/articles/chitem.aspx?aid=2119

VRX496 is the first and only lentiviral vector therapy approved by the FDA for clinical trials, according to VIRxSYS. The backbone of VRX496 consists of a genetically engineered version of HIV in which all the infectious components are removed and replaced with the therapeutic payload—a long antisense sequence that targets the HIV envelope protein and cripples the virus.



GEOVAX


http://www.wbir.com/news/national/story.aspx?storyid=43144&provider=gnews

The vaccine uses a decoy virus with some of the genetic material of the aids virus but not enough for anyone to ever get the disease itself from the shot, according to Dr. Harriet Robinson, Ph. D., of the Emory Vaccine Center.

"It exposes your immune system to a pathogen like a virus or bacteria so before you've seen it you set up memory cells,” Dr. Robinson said, “and then these memory cells mobilize should you get the actual infection."

The MVA component of the GeoVax vaccine is used to deliver genes expressing non-infectious forms of the three major proteins of HIV: Gag, Pol, and Env.

“It raises both antibodies that can block the virus and it raises white blood cells called t cells that can kill the virus infected cells,” said Dr. Robinson. “So it really has two methods of controlling an HIV/AIDS infection once it enters the body."

The vaccine’s success with the simian AIDS virus has been nothing short of remarkable. Not only did the vaccine prevent the infection, it kept it under control for the monkeys that already had it, putting it in a kind of remission.



Lets see what happens when these genetically engineered HIV-resistant T-cells (Virxsys, geovax) are combined with viral cleanup by HAART, like the super-effective KP1461. We talk about years of semi-natural viral suppression, no meds, no side-effects. And this is only about 5 years from now. So some of us might be lucky enough to survive to that day.


« Last Edit: November 04, 2007, 06:38:15 PM by Customer »

Offline J220

  • Member
  • Posts: 587
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #2 on: November 04, 2007, 08:28:50 PM »
Fantastic news...!

And not to split hairs, but I think that VRX496 and the Geovax vaccine are quite different. The VRX496 must be directly inserted into the immune cells, after their cultivation through a dialisis-like machine, and then the modified cells reinserted into the body. The Geovax vaccine is exactly that, a vaccine, that causes the body to recognize the pathogen and creates antibodies and memory cells capable (we hope, we hope!) of killing the virus and infected cells. In addition VRX496 will probably not be used (in my opinion) as a preventive method, whereas Geovax can be either preventive or therapeutic. Now, the target is the same of course, making the body able to fight off the virus on its own, and these two candidates are very encouraging. I think as far as similarities go, Geovax is more similar to Dr. Kang's vaccine which is set to begin trials soon. In any case, these are all good news, and we shall keep an eye on them!
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline bobino

  • Member
  • Posts: 264
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #3 on: November 05, 2007, 10:29:45 PM »

Do I understand correctly that both of the vaccines you're discussing are therapeutic in nature?
Suivons les rivières
Gardons les torrents
Restons en colère
Soyons vigilants

Offline J220

  • Member
  • Posts: 587
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #4 on: November 05, 2007, 10:55:52 PM »
Geovax is a vaccine, VRX496 is a gene therapy. I believe Geovax is being developed for both preventive and therapeutic purposes. VRX496 seems to be under development mainly as therapeutic method, as a way to keep people off meds hopefully permanently. Both are great candidates, and reason for hope! Cheers, J.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Customer

  • Member
  • Posts: 98
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #5 on: November 09, 2007, 12:17:26 PM »
Read this J220....

VIRxSYS (www.virxsys.com) is developing a unique technology that is advancing both gene therapy and HIV treatment. VRX496 uses a lentiviral vector to deliver a payload to block the replication of HIV.... (From the link above)

Both Geovax and Virxsys can be used for treatment (as opposed to vaccination). Virxsys trials (phase 1 and 2) were conducted with HIV-infected patients. With these technologies combined to HAART, I expect no less than a sustained viral response lasting several years!





« Last Edit: November 09, 2007, 12:25:14 PM by Customer »

Offline bimazek

  • Member
  • Posts: 781
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #6 on: November 09, 2007, 12:58:00 PM »
hey guys this is great new information thanks

this can also be used for therapudic treatment of all of us someday not just preventative
what is really great it they use like 50 pieces of the virus so the immune system can really get a look and feel of what it is up against and stop the hiv virus

there were many great posts in the past on these two vaccines so do a search for   virxsys or geovax on the search fcn on this site -- many great posts... the big thing i remember is they have like a huge new 200 million dollar building to work out of in atlanta or something

i dont have time now but if you find the older threads please link them from this post
thanks guys

Offline NYCguy

  • Member
  • Posts: 180
http://biz.yahoo.com/prnews/081020/aqm035.html?.v=68

Geovax FINALLY released some news on their phase 2 trials, which were supposed to be started in 2007! (which their website still claims).  And damn good that they did, because I just emailed them a week ago and got no response.  However, I am pleased that they are spending their time on research and not updating the website.  The article states they have shipped vaccine for a Phase 2a trial in 225 people - 150 to get vaccine and 75 for placebo.  My understanding is that these are healthy (eg non-poz - I hate the term 'healthy' used in this way!  I'm pretty healthy ya know) volunteers to test the vaccine for prophylactic purposes.  However...before a blitz of 'why aren't they working on therapeutic?' from what I have read, it seems that they believe this vaccine could work therapeutically as well. In fact the aim is not to prevent infection, but to keep those vaccinated from progressing after infection.  At least that's what has happened in monkeys so far.  Unless I've missed something, none of the few people who received vaccine in phase I have subsequently become poz (unless they just aren't reporting it).

11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline messer

  • Member
  • Posts: 21
I emailed GeoVax back in June when I noticed the therapeutic trial planned for 2008 had changed to being planned for 2009!    GeoVax did respond to an email I sent regarding the changed trial date.     They said, " regarding your question about moving the therapeutic clinical trial, it was not really moved, the agency of the government that will be conducting the clinical has an extremely long process period, including a number of committees that must give approval.    Currently, the agency predicts about 12 more months before commencement."
"As you know we are currently looking forward to commencing Phase 2 with the preventative version of the vaccine.    That too had to overcome many committees for approval.    Thankfully we are near the last group, but an important one the FDA.    Then we can make an announcement."
End quote.
That would be June of next year for commencement of a therapeutic trial.    Maybe.   

   

Offline NYCguy

  • Member
  • Posts: 180
messer thanks for sharing that!  When I look on the site under 'human trials' I'm still seeing 2007, but maybe you found the new date in a press release.  But no matter, I'm glad things are still moving forward for them (I even bought some stock so I'm cheering on two fronts, lol).  It seems to make sense this would work therapeutically if worked representatively.  Do you have any feeling for when we might see some data from the IIa?  Maybe in 6 mo?
 
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline messer

  • Member
  • Posts: 21
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #10 on: October 21, 2008, 04:46:30 PM »
NYCguy, I found the therapeutic trial information under the GeoVax website, under the heading of "corporate fact sheet"...you(anyone)can readily access the information.    What I have really liked about the GeoVax site is that they communicate two or three times a month about whatever is going on within the company, their research, and progress(or not)with the trials.   Maybe some of it is hype.   Maybe not!   Reader beware, right?    Certainly it continues to be informative.   Merck didn't seem to be nearly as forthcoming with information as have the GeoVax crew with their product.   I like GeoVax's apparent transparency.   And maybe the transparency is one of the reasons to be hopeful of success with the GeoVax clinical trials.
My inquiry to GeoVax back in June was something along the lines of "hey, why did you move the therapeutic trial to vaccinating the infected to 2009 from 2008 when you had such good therapeutic results in primates"?!   The response from GeoVax is what was posted above.
Preventative preliminary data in 6 months?   We can hope!     From what I've read, Harriett Robinson and Robert McNally are anxious for the trials to move forward as quickly as possible.    They live the with knowledge that humanity is waiting, and ever hoping.   Plus, Bionor Immuno has already initiated phase 2 trials here in the US with their MVA vaccine construct.    So, there is competitive pressure to get to market as quickly as possible, if they have they the goods.     Exciting, even if daunting.

Offline messer

  • Member
  • Posts: 21
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #11 on: October 22, 2008, 04:27:03 PM »
Clarification...Bionor-Immuno therapeutic trial is a PEPTIDE vaccine currently in a phase 2b involving 345 positive people.
Bavarian-Nordic has a MVA therapeutic vaccine currently testing in phase 1 and 2 safety trial.
 ::)


Offline NYCguy

  • Member
  • Posts: 180
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #13 on: October 28, 2008, 07:28:50 PM »
veritas - I think that's the same story I posted above.
messer - thanks for that!  I was just reading about Bionor and didn't see anything about it being MVA and then saw your correction.  I didn't know about Bionor and wow they are pretty far along with some amazing results, although they don't give much specific information and a very small sample, but these are real, positive people with a real response - something geovax has yet to try sometime in the future.  And yes, the heat is definitely on for getting to market.  I tend to be a little cynical and think that some of Geovax's transparency is to actually to keep investor interest, especially considering this is a small biotech with only ONE product candidate and the founders stand to make millions if this really goes anywhere.  there was also little webcast thing on wallst.net with the CEO that rubbed me a little bit the wrong way

http://tv.wallst.net/r/3-minute-press/Bob-McNally-GOVX-BB/306/1207

However, the proof is in the pudding and so far everything looks good for them, so fingers crossed.  And now I gotta watch Bionor too!
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline hahaha

  • Member
  • Posts: 123
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #14 on: October 29, 2008, 02:00:46 AM »
I emailed GeoVax back in June when I noticed the therapeutic trial planned for 2008 had changed to being planned for 2009!    .... the agency of the government that will be conducting the clinical has an extremely long process period, including a number of committees that must give approval.    "

My question is a bit remote, but.....WHY it take SO LONG to pass the approval for government committee?  DON'T THEY KNOW PEOPLE DIE EVERYDAY?  Is it because of inefficient of beureacracy, or is there any other concern?
Howcome "starting" a clinical trial so difficult?  I thought it shall be ->evaluation of no safety concern > recruit patient > start the clinical trial. 

Am I too naive?
Shall we HIVer fight together for our right (of surviving) and protest government inefficiency for the approval of starting a clinical trial?   
Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline leit

  • Member
  • Posts: 236
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #15 on: October 30, 2008, 12:29:16 AM »
Am I too naive?

Maybe a bit: every trivial press release can raise the value of the stocks of poor OTC companies like GeoVax (look at http://www.otcbb.com/asp/Info_Center.asp?symbol=govx), while a trial failure would make them die.
So, why rush?


Offline mewithu

  • Member
  • Posts: 160
  • mewithu
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #16 on: October 30, 2008, 12:43:50 AM »
You still have to prove that it want cause the virus to start in the body at some time.
1997 is when I found out, being deathly ill. I had to go to the hospital due to extreme headache and fever. I fell coma like,  two months later weighing 95 pounds and in extreme pain and awoke to knowledge of Pancreatis, Cryptococcal Meningitis, Thrush,Severe Diarea,  Wasting, PCP pneumonia. No eating, only through tpn. Very sick, I was lucky I had good insurance with the company I worked for. I was in the hospital for three months that time. 
(2010 Now doing OK cd4=210  VL= < 75)
I have become resistant to many nukes and non nukes, Now on Reyataz, , Combivir. Working well for me not too many side effects.  I have the wasting syndrome, Fatigue  . Hard to deal with but believe it or not I have been through worse. Three Pulmonary Embolism's in my life. 2012 520 t's <20 V load

Offline messer

  • Member
  • Posts: 21
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #17 on: October 30, 2008, 12:04:08 PM »
Leit, excellent points!   Like HaHaha, it can cause one to become manic to wonder why, if the therapeutic version of the vaccine was so successful years ago in therapeutically treating the monkeys...then...why not now, or sooner, toss us a lifeline, please with a human version of the therapeutic vaccine.   Is the FDA yawning at the therapeutic version?   The FDA just funded GeoVax with 15 million to help them along with the preventative trials.   GeoVax is trading at about .15 a share right about now, it could be a blockbuster, or it could just be a bust.     Like NYCguy said, its a one product company...and rushing things, possibly to failure, just isn't in their interest!    From my position, providing a successful therapeutic to the infected, if it reduces infectivity, could do more to stop the pandemic then vaccinating everyone else in the rest of the world.    Their aim is to do both.   What is or can be be done at a grassroots level to accelerate and or to broaden a Geovax therapeutic trial?   Anything?   
In the meantime, we can appreciate Bionor-Immuno as having the largest therapeutic trial currently underway in the world! 

Offline John2038

  • Member
  • Posts: 1,529
  • Happiness is a journey, not a destination.
    • HIV Research News (Twitter)
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #18 on: December 01, 2008, 10:33:43 AM »
GeoVax set for HIV vaccine trials

GeoVax Labs Inc.’s phase 2a human HIV vaccine trials are set for sites across North and South America, the Atlanta biotechnology company said Monday.

The trials are conducted in collaboration with The National Institutes of Health and the HIV Vaccine Trials Network.

The trial will involve 150 vaccinees and 75 placebo participants. The vaccine regimen employs a two-component "prime-boost strategy." Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the second vaccine, GeoVax's HIV-1 Modified Vaccinia Virus boost. Both vaccines express the three major proteins of the AIDS virus. These proteins mimic more than 50 percent of the components of the AIDS virus (HIV-1) but cannot cause AIDS. GeoVax AIDS vaccines are designed to prevent HIV-1 virus infection which causes AIDS.


Source



Offline John2038

  • Member
  • Posts: 1,529
  • Happiness is a journey, not a destination.
    • HIV Research News (Twitter)
Re: Excellent Results Received From GeoVax's Full-Dose HIV/AIDS Vaccine Trial
« Reply #19 on: December 01, 2008, 10:37:18 AM »
GeoVax's Phase 2a HIV/AIDS Vaccine Human Trials to Begin in North and South America

ATLANTA, Dec. 1 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (GOVX), an Atlanta-based biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced today that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America. These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN).

"It is of significant importance to report this major development on this very day in which the world commemorates WORLD AIDS DAY. Despite setbacks reported recently with other vaccine trials, our vaccine is progressing and paving the way for a solution that would potentially make this commemorative day more joyful," commented Dr. Robert McNally, GeoVax's President and CEO.

Dr. Harriet Robinson, Vice President of Research and Development of GeoVax Labs, Inc., stated, "We feel privileged to be in the position to launch our Phase 2a human trial. Going forward, each clinical site's review board will start the vaccination process, when deemed appropriate and ready. Accordingly, HVTN's pharmacy will release the vaccines to each designated institution as directed by each site's local review board."

Trial site arrangements and other details of the study were confirmed in a recent meeting held in Seattle, Washington, between the HVTN and GeoVax's scientific personnel. The Phase 2a human clinical trial will involve 150 vaccinees and 75 placebo (control) participants. The vaccine regimen employs a two-component "prime-boost strategy." Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the second vaccine, GeoVax's HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines express the three major proteins of the AIDS virus. These proteins mimic more than 50% of the components of the AIDS virus (HIV-1) but cannot cause AIDS. GeoVax AIDS vaccines are designed to prevent HIV-1 virus infection which causes Acquired Immunodeficiency Disease (AIDS).

The Seattle meeting also achieved further progress with GeoVax's therapeutic trial. Information on this and other developments will be reported in a timely fashion in the near future.


Source

Offline NYCguy

  • Member
  • Posts: 180
For those of you following this vaccine, such as myself, there is a good chance we will see some preliminary results of the phase II preventative trial this Thurs when they host a panel at the Bio International convention in Atlanta.  Keep fingers crossed that they will also announce a start date for therapeutic trials.  Noises are being made about later this summer...

http://finance.yahoo.com/news/GeoVax-to-Exhibit-at-the-2009-prnews-15198222.html?.v=1
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline mousey

  • Member
  • Posts: 22
Is this really a cure, if it really works?  :'(
:: Believe in a cure ::

Offline newt

  • Member
  • Posts: 3,885
  • the one and original newt
Quote
Is this really a cure, if it really works?

No, it's a parachute
"The object is to be a well patient, not a good patient"

Offline NYCguy

  • Member
  • Posts: 180
In monkey trials, monkeys who were given the vaccine prior to SIV challenge were protected for several years without treatment.  My understanding is that they don't really expect it to actually prevent infection but to protect from progression.  Presumably this same theory would apply if used therapeutically, but there hasn't been much info that I've seen about how this would work.  I certainly welcome the trials, however!
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline messer

  • Member
  • Posts: 21
Newt, What do you mean by "a parachute"?   That it may stop or delay progression?  Please elaborate. 
Thanks...

Offline freewillie99

  • Member
  • Posts: 310
No, it's a parachute

LOLZ!  What does that mean?  Newt, you're a man of mystery!
Beware Romanians bearing strange gifts

Offline mousey

  • Member
  • Posts: 22
LOLZ!  What does that mean?  Newt, you're a man of mystery!

I really hope something works. As long as it can prevent the virus to progress to advanced AIDS and of cos' to prolong lives.
:: Believe in a cure ::

Offline NYCguy

  • Member
  • Posts: 180
wondering about 'parachute' myself...

Today, Chuck Panozzo, of Styx fame who came out as gay and poz in the early 90s joined the PR bandwagon for Geovax.  Hopefully this all bodes well for tomorrow!

Chuck Panozzo, Founder of Rock Band Styx, Joins GeoVax Labs, Inc. as an Advocate for Its HIV/AIDS Vaccine

http://finance.yahoo.com/news/Chuck-Panozzo-Founder-of-Rock-prnews-15303751.html?.v=1
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline freewillie99

  • Member
  • Posts: 310

Today, Chuck Panozzo, of Styx fame who came out as gay and poz in the early 90s joined the PR bandwagon for Geovax.  Hopefully this all bodes well for tomorrow!


No doubt.  Hopefully he won't be singing "Fooling Yourself (The Angry Young Man)".
Beware Romanians bearing strange gifts

Offline freewillie99

  • Member
  • Posts: 310
Last night I wondered what Geovax' stock price did yesterday in lieu of today's conference.  Wow.  This is normally a stock that is very lightly traded, averaging around 300k shares a day.  Yesterday it traded over 6 million shares.  Talk about a roller coaster: It started at .37 at opening, basically treaded water for a couple hours, then went screaming off a cliff straight down to .22 within 20 minutes, a huge percentage drop.  It then somewhat recovered to end the day at .29 - essentially where it started the week.  However, a month ago it was trading at .13.

What does all this mean?  That's for someone who knows more about this type stuff than me to say.  But the month long run up culminating in a peak yesterday morning at almost 3 times the price of a month ago, the massive, almost instantaneous drop yesterday, as well as yesterday's huge volume are really interesting.  Obviously there are other people watching this as well.
Beware Romanians bearing strange gifts

Offline messer

  • Member
  • Posts: 21
NYCguy, I take it that Newt infers that by parachute, means the vaccine may not prevent infection but if infected then the vaccine would act a parachute, possibly preventing disease progression.

Offline Inchlingblue

  • Member
  • Posts: 3,119
  • Chad Ochocinco PETA Ad
Last night I wondered what Geovax' stock price did yesterday in lieu of today's conference.  Wow.  This is normally a stock that is very lightly traded, averaging around 300k shares a day.  Yesterday it traded over 6 million shares.  Talk about a roller coaster: It started at .37 at opening, basically treaded water for a couple hours, then went screaming off a cliff straight down to .22 within 20 minutes, a huge percentage drop.  It then somewhat recovered to end the day at .29 - essentially where it started the week.  However, a month ago it was trading at .13.

What does all this mean?  That's for someone who knows more about this type stuff than me to say.  But the month long run up culminating in a peak yesterday morning at almost 3 times the price of a month ago, the massive, almost instantaneous drop yesterday, as well as yesterday's huge volume are really interesting.  Obviously there are other people watching this as well.

Someone on the forums, clsoca, is a trader, I'm pretty sure. I'll send him a message to see what he thinks, I'm also curious.

Offline Assurbanipal

  • Member
  • Posts: 2,173
  • Taking a forums break, still see PM's
Last night I wondered what Geovax' stock price did yesterday in lieu of today's conference.  Wow.  This is normally a stock that is very lightly traded, averaging around 300k shares a day.  Yesterday it traded over 6 million shares.  Talk about a roller coaster: It started at .37 at opening, basically treaded water for a couple hours, then went screaming off a cliff straight down to .22 within 20 minutes, a huge percentage drop.  It then somewhat recovered to end the day at .29 - essentially where it started the week.  However, a month ago it was trading at .13.

What does all this mean?  That's for someone who knows more about this type stuff than me to say.  But the month long run up culminating in a peak yesterday morning at almost 3 times the price of a month ago, the massive, almost instantaneous drop yesterday, as well as yesterday's huge volume are really interesting.  Obviously there are other people watching this as well.

"Buy on the rumour, sell on the news" as they say on Wall Street
5/06 VL 1M+, CD4 22, 5% , pneumonia, thrush -- O2 support 2 months, 6/06 +Kaletra/Truvada
9/06 VL 3959 CD4 297 13.5% 12/06 VL <400 CD4 350 15.2% +Pravachol
2007 VL<400, 70, 50 CD4 408-729 16.0% -19.7%
2008 VL UD CD4 468 - 538 16.7% - 24.6% Osteoporosis 11/08 doubled Pravachol, +Calcium/D
02/09 VL 100 CD4 616 23.7% 03/09 VL 130 5/09 VL 100 CD4 540 28.4% +Actonel (osteoporosis) 7/09 VL 130
8/09  new regimen Isentress/Epzicom 9/09 VL UD CD4 621 32.7% 11/09 VL UD CD4 607 26.4% swap Isentress for Prezista/Norvir 12/09 (liver and muscle issues) VL 50
2010 VL UD CD4 573-680 26.1% - 30.9% 12/10 VL 20
2011 VL UD-20 CD4 568-673 24.7%-30.6%
2012 VL UD swap Prezista/Norvir for Reyataz drop statin CD4 768-828 26.7%-30.7%

Offline NYCguy

  • Member
  • Posts: 180
Hi all,

Well I was watching the stock pretty closely this week too, as I've been picking up a few shares here and there whenever I have a few extra $ (not that often, unfortunately).  It was really something how the volume and price kept rising this week, to peak in a frenzy on Wednesday.  And now it's tapered off to roughly average volume and the price settled around .25 or so.  I'm guessing that pretty much everyone who owns shares was looking for something to happen on Thursday, myself included, but guess what...not a single press release or story so far!  Hopefully no news is good news...

I did find this article in Southern Voice, an Atlanta gay newspaper.  It's a profile of Harriet Robinson and doesn't have much new info, but she does explain the vaccine in layman's terms and again defends it as being better than Merck, et al.  She also states that they are working 'very aggressively' on the therapeutic part of the vaccine, which is nice to hear.  The one thing I didn't like is that the article claims the first two volunteers were vaccinated this month, while previous releases have implied it started some time ago...  There is also some mention of the gene/muscle vaccine discussed in another thread I believe.

http://www.sovo.com/2009/5-22/news/localnews/10123.cfm

ps messr - thanks for explaining 'parachute' !
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline newt

  • Member
  • Posts: 3,885
  • the one and original newt
Quote
NYCguy, I take it that Newt infers that by parachute, means the vaccine may not prevent infection but if infected then the vaccine would act a parachute, possibly preventing disease progression.

This is indeed true ;-)

The problem for preventative vaccines is too many targets. HIV has many entry points and many ways of getting to them.

For therapeutic vaccines, the problem is enabling the immune system to deal with the virus in its own natural way without permitting further replication.

In terms of eradication (bit further than the current vaccine candidates go) the problem is HIV stores itself in our own cellular genetic material and is therefore hard to get at without bits and pieces escaping and hiding somewhere else in the body.

Hence therapeutic vaccines being a parachute, much like combo.

The efficacy question GeoVax needs to answer is does the damn thing work in humans for HIV. Most of the science is on monkeys on SIV.

The safety question GeoVax needs to answer is what will the expected low but significant level of virus replication mean in terms of health. because, as planned, the vaccine will leave you with a few 1,000 copies of HIV per drop of blood. Is this bad or no?  hmmm...

The ethical problem for therapeutic vaccine trials is that to be truly conclusive these studies need to be long. At some point brave souls will have to forego combo for longer than the outside limit that the body can control the virus, like more than 6 months, and therefore they will have an increased risk of serious illness or death.
"The object is to be a well patient, not a good patient"

Offline messer

  • Member
  • Posts: 21
The efficacy question GeoVax needs to answer is does the damn thing work in humans for HIV. Most of the science is on monkeys on SIV.

Indeed!   If only we were all monkeys!    All the GeoVax monkeys(except one) are doing quite fine with the therapeutic SIV vaccine version.

I think this is also the story of Merck Step Trial...worked beautifully in primates...bombed like a turd in humans.    But, the GeoVax product is quite different in many ways than the Merck product.   

Wishing we could do a rally at the GeoVax office one afternoon to make an encouraging point to Robert McNally and Harriett Robinson and others that there is such strong interest in the therapeutic trial getting underway quickly.    I'm sure he is already well aware of the need.  Just the same, I wonder if the locals in Atlanta have had an opportunity to get together for a peaceful, encouraging demonstration of just how much anticipation there is for a therapeutic trial to start.

Offline moskimo

  • Member
  • Posts: 31
assuming these trials are successful, when will the vaccine get to us here in africa, two yrs, five yrs or do you know how long, when atripla is not yet in south africa two years after appearing in the US market.Honestly i wish i live in  america with this virus, i wont even bother myself about it, i will only take my meds.i envy you guys in the US.

Offline Inchlingblue

  • Member
  • Posts: 3,119
  • Chad Ochocinco PETA Ad
assuming these trials are successful, when will the vaccine get to us here in africa, two yrs, five yrs or do you know how long, when atripla is not yet in south africa two years after appearing in the US market.Honestly i wish i live in  america with this virus, i wont even bother myself about it, i will only take my meds.i envy you guys in the US.

There are organizations such as the Gates Foundation that would consider it a top priority to get any vaccine that works to Africa and to the rest of the Third World. Let's face it, if it were not for HIV/AIDS in the Third World, I don't think Bill and Melinda Gates, bless their hearts, would be at all interested in HIV/AIDS. It's a shame that you don't have the very latest medications and I'm not at all implying that we in the U.S. have it better than those in Africa, but if I were you I would prefer to be in Europe or maybe Canada, not the U.S.

The health care system in the U.S. is a real mess! Considering we are the richest country in the world and spend the most of any other G7 country for health care we get the least in return dollar for dollar. There are millions of people in the U.S. who don't have health insurance or are under-insured and if they get sick, they go bankrupt.

Look at what is happening in California right now with millions of dollars being slashed from ADAP and other HIV/AIDS services. Several states such as Montana and South Carolina have waiting lists for ADAP so what happens to someone with HIV who needs to start meds and can't afford it if they live in those states? I'll tell you what happens: they either have to move or wait however long it takes on the waiting list and hope and pray that they don't get sick with an OI and land in the hospital while they wait months if not years to qualify for ADAP.

The system in the U.S. is geared to work only for someone who has a good job and no major health problems. As soon as someone actually gets sick, especially with something serious such as cancer, they are screwed. They cannot work because they are sick and if they cannot work they lose their health insurance - just when they need it most. How much sense does that make? And even if you don't get sick, if you lose your job for whatever reason, as so many millions are right now due to the economy, there goes their health insurance too. Sure, there's COBRA, yada yada yada, but it costs a fortune. Sure there's temporary help right now in paying COBRA but these are all just stop gap measures.

Any system that relies on one's employer for health care is ridiculous. It's part of the reason GM went bankrupt. Huge companies like that are basically big health insurers that happen to make cars on the side, most of their expenses were going to pay insurance and other benefits to their unions. The system simply does not work, period. Let's hope change is coming soon.

Generic Atripla, called Viraday, is not yet available in South Africa? It is in India and other countries that are not very rich.
« Last Edit: June 12, 2009, 08:19:13 PM by Inchlingblue »

Offline John2038

  • Member
  • Posts: 1,529
  • Happiness is a journey, not a destination.
    • HIV Research News (Twitter)
Sorry for this diversion about the drug access program ins South Africa:

In South Africa, the Atripla is prescribed by the Public Academic Hospital in its equivalent form (efavirenz + 3TC + viread), where 3TC is replacing FTC.

Some states (such as Free State) have refused, for economical reasons, to prescribe drugs to new patients last year, but accordingly to them, this ban have now been lifted (but some patients are still complaining that they still haven't access to their meds). I don't kno what the status is today.

Otherwise, all the drugs are available if the patient get a presciption from a clinic, private hospital or doctor.
In such case, the treatment is not free, and the Atripla equivalent will cost around 75USD/month (700R).
Others new drugs can also be ordered (such as Isentress) if the Dr fill a special form to access them.

If the patient is insured (typically since before the infection) the meds costs will be covered.

Globally speaking, the situation is fine in South Africa if you are a South African citizen (ID card) or if you have a decent work.
HIVers who are illegal in South Africa and without a decent revenue are having a problem:
the government won't provide them free medical care, excepting if they can get the asilum, and again for them, the only way is to earn enough money to go through the private hospital path.

May God Bless them all

Offline loneranger

  • Member
  • Posts: 16
For those of you following this vaccine, such as myself, there is a good chance we will see some preliminary results of the phase II preventative trial this Thurs when they host a panel at the Bio International convention in Atlanta.  Keep fingers crossed that they will also announce a start date for therapeutic trials.  Noises are being made about later this summer...

http://finance.yahoo.com/news/GeoVax-to-Exhibit-at-the-2009-prnews-15198222.html?.v=1

Hi guys. Have been following this thread for a while and am surprised that no formal announcement was made re GeoVax Vaccine after the Bio International Convention - or did I miss something? Can't find any info on a google search.

Offline NYCguy

  • Member
  • Posts: 180
Quote
Hi guys. Have been following this thread for a while and am surprised that no formal announcement was made re GeoVax Vaccine after the Bio International Convention - or did I miss something? Can't find any info on a google search.

I think the reason is simply that they don't have enough data yet, or for whatever reason, they aren't ready to release it.  My suspicion is that actual vaccination of people has only very recently begun.  So, expect something by early fall?  Just a guess.

Here is a news story which gives merit to Geovax' claim that they are aggressively pursuing therapeutic trials:

http://finance.yahoo.com/news/GeoVax-Signs-HIVAIDS-Vaccine-prnews-2478450462.html?x=0&.v=1
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline loneranger

  • Member
  • Posts: 16
Thanks for the update NYCguy - fingers crossed this keeps moving forward into clinical trials, it looks very promising!  :)

 


Terms of Membership for these forums
 

© 2014 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.