Therapeutic Vaccine potential

[veritas]

http://www.bio-medicine.org/biology-technology-1/ImmunoVaccine-Technologies-Partners-with-FIT-Biotech-to-advance-a-therapeutic-HIV-vaccine-12266-1/

"This pre-clinical research partnership will combine the complementary technologies of DepoVax(TM) and GTU(R) MultiHIV. Both IVT and FIT Biotech will examine the novel vaccine's capabilities of inducing cell-mediated and humoral immunity against HIV virus"

Very preliminary.

v

[YellowFever]

I *think* this news update is related to the same technology. But feel free to start another thread:

Finnish company FIT Biotech has developed a vaccine to be tested in a large clinical trial. Hundreds of HIV patients will participate in the comprehensive study, which is scheduled to begin next year.

http://yle.fi/uutiset/finnish_hiv_vaccine_testing_to_begin/7006600

[Jmarksto]

It looks like FIT Biotech has been at this for a while, with trials back to 2002 or so although the results on their website are sparse. Here is a Phase II study with results from 2012.

www.ncbi.nlm.nih.gov/pubmed/22549090

BACKGROUND: Combination highly active antiretroviral therapy (HAART) has significantly decreased HIV-1 related morbidity and mortality globally transforming HIV into a controllable condition. HAART has a number of limitations though, including limited access in resource constrained countries, which have driven the search for simpler, affordable HIV-1 treatment modalities. Therapeutic HIV-1 vaccines aim to provide immunological support to slow disease progression and decrease transmission. We evaluated the safety, immunogenicity and clinical effect of a novel recombinant plasmid DNA therapeutic HIV-1 vaccine, GTU(®)-multi-HIVB, containing 6 different genes derived from an HIV-1 subtype B isolate.

METHODS:63 untreated, healthy, HIV-1 infected, adults between 18 and 40 years were enrolled in a single-blinded, placebo-controlled Phase II trial in South Africa. Subjects were HIV-1 subtype C infected, had never received antiretrovirals, with CD4 ≥ 350 cells/mm(3) and pHIV-RNA ≥ 50 copies/mL at screening. Subjects were allocated to vaccine or placebo groups in a 2:1 ratio either administered intradermally (ID) (0.5mg/dose) or intramuscularly (IM) (1mg/dose) at 0, 4 and 12 weeks boosted at 76 and 80 weeks with 1mg/dose (ID) and 2mg/dose (IM), respectively. Safety was assessed by adverse event monitoring and immunogenicity by HIV-1-specific CD4+ and CD8+ T-cells using intracellular cytokine staining (ICS), pHIV-RNA and CD4 counts.

RESULTS:Vaccine was safe and well tolerated with no vaccine related serious adverse events. Significant declines in log pHIV-RNA (p=0.012) and increases in CD4+ T cell counts (p=0.066) were observed in the vaccine group compared to placebo, more pronounced after IM administration and in some HLA haplotypes (B*5703) maintained for 17 months after the final immunisation.

CONCLUSIONS:The GTU(®)-multi-HIVB plasmid recombinant DNA therapeutic HIV-1 vaccine is safe, well tolerated and favourably affects pHIV-RNA and CD4 counts in untreated HIV-1 infected individuals after IM administration in subjects with HLA B*57, B*8101 and B*5801 haplotypes


A few things about this study:

1. It looks like the vaccine was focused on the subtype B, but tested on subjects with subtype C - perhaps someone can help explain that.

2. It would be good to see more quantitative results in terms of how much of a viral reduction, and CD4 increase there was - the P values only say that the results were statistically significant.

[Dr.Strangelove]

Here's a 2010 article in Nature that mentions FIT Biotech's vaccine:

The FIT vaccine comprises a combination of gene fragments designed to make the patient immune to six viral proteins. In around 80% of patients receiving treatment, the virus was suppressed and CD4+ levels were maintained two years after therapy began.

Sounds promising, no?