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Author Topic: GeoVax Announces Publication of Phase 2a Clinical Trial in The Journal of Infect  (Read 1010 times)

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Offline GoForIt

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  • Posts: 109
http://online.wsj.com/article/PR-CO-20140123-908989.html

GeoVax Announces Publication of Phase 2a Clinical Trial in The Journal of Infectious Diseases

Trial Results Provide Further Support for Vaccine Safety and Immunogenicity

ATLANTA, GA--(Marketwired - Jan 23, 2014) - GeoVax Labs, Inc. (OTCQB: GOVX) announced today the publication of the results of Phase 2a clinical testing of its JS7/MVA62B AIDS vaccine, GOVX-B11. The article, titled "Specificity and Six-Month Durability of Immune Responses Induced by DNA and Recombinant Modified Vaccinia Ankara Vaccines Expressing HIV-1 Virus-Like Particles" was published on-line in The Journal of Infectious Diseases. An abstract of the article can be located at http://www.ncbi.nlm.nih.gov/pubmed/24403557.

GeoVax is developing two vaccine components: a recombinant DNA vaccine and a recombinant MVA (modified vaccinia Ankara) vaccine. Both produce non-infectious virus-like particles displaying the HIV envelope protein (Env). The vaccines induce humoral (antibody) and cellular (T cell) responses. Antibodies have the potential to block virus before it infects cells. T cells have the potential to recognize and kill cells that become infected by virus that gets past the antibody.

The publication reports the results of two different trial regimens: (1) priming with two doses of the recombinant DNA vaccine and boosting with two doses of the recombinant MVA vaccine (DDMM regimen) and (2) priming and boosting with a total of three doses of the recombinant MVA vaccine (MMM regimen). The Phase 2a trial, initiated in 2009 and completed in 2012, included 299 participants. It was sponsored by National Institutes of Health (NIH) and conducted by the NIH-funded HIV Vaccine Trials Network (HVTN). GeoVax also received support for the preclinical development of its DNA and MVA vaccines from the NIH.

The vaccines showed excellent safety characteristics in both trial regimens. Antibody responses to Env were highest in the MMM group, whereas T cell response rates were highest in the DDMM group. At peak response, 93.2% of the DDMM group and 98.4% of the MMM group had binding antibodies for Env. These binding antibodies were more frequent and of higher magnitude for the more conserved transmembrane subunit of Env (gp41) than the receptor binding subunit (gp120) of Env. Antibody responses showed excellent durability, declining by less than 3-fold from their peak responses at 6 months post vaccination. Responding CD4+ and CD8+ T cells were biased towards Gag and showed good functionality with greater than 70% of responding T cells producing two or three of four tested cytokines.

The comparison of binding antibodies between the two regimens favored the MMM regimen, whereas comparison of cellular immunity favored the DDMM approach. Given that the antibody responses after the 2nd MVA inoculation in the MMM regimen were similar in magnitude to those after the 2nd (and final) MVA inoculation in the DDMM regimen, GeoVax plans to advance a DDMMM regimen with a 3rd MVA boost to advanced clinical trials. The goal of the DDMMM regimen is to optimize both antibody and T cell responses.

"We are encouraged with the results seen in this trial, as the vaccine is safe and predictably induces a wide variety of immune responses directed against HIV," notes Dr. Paul A. Goepfert of the University of Alabama at Birmingham, the study's lead investigator.

"I am very pleased with the reproducibility of our Phase 1 results in a larger Phase 2a trial. I am also encouraged by the longevity of the antibody response to Env," said GeoVax's Chief Scientific Officer, Dr. Harriet L. Robinson. "In the partially successful RV144 trial in Thailand, antibody responses to Env decreased by 10-fold over a six month period, and the waning of the Env-specific antibody was associated with a waning of protection. The greater durability of our antibody could indicate we will achieve more sustained protection."
08/09/2013   Diagnosed WB positive
08/20/2013   CD4-506(28%)  VL-10,800
09/12/2013   CD4-391(28%)  VL-14,900
09/17/2013   Start ART (Truvada & Tivicay)
10/11/2013   CD4-377(26%)  VL-UD
12/20/2013   CD4-590(??%)  VL-UD
03/18/2014   CD4-660(29%)  VL-UD
07/22/2014   CD4-613(29%)  VL-UD
08/01/2014    Start TAF Clinical Trial
10/09/2014   CD4-498(29.5%) VL-UD

Offline xinyuan

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  • Posts: 186
Strongly suspect this is for HIV negative people.

While I'm all for prevention, does little for our population.

 


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