Testing and protocol
Encouraging results on macaques
A publication shows that when tested on monkeys, 7 macaques were immunized with « Tat Oyi » and then infected with HIV a year after the start of immunization, the publication has shown that the result of vaccination with « Tat Oyi « resulted in a significant decline in viremia for 5 macaques 7, much higher than macaques vaccinated with tat toxoid Aventis Pasteur. The most striking result of this study was that the tanks cells were undetectable for 7 macaques vaccinated with the « Tat Oyi » and a macaque, viremia was very low because it remained negative. It was interesting to see that it had the highest rate of anti-Tat antibodies to 6 other monkeys. There was for this macaque at the same sero-conversion retro in the study cohort Gabonese patients. Studies published in the journal retrovirology R (Watkins et al, 2006). These results in animals were confirmed by Harvard University and a publication confirmed that it is indeed the antibodies against the « Tat » protein that enabled the vaccinated macaques to resist the virus.
January 2013: Start of clinical trials
Clinical trials allowed January 25, 2013 of 48 HIV-positive patients were held April 10, 2013 at the Hospital of Clinical Investigation Centre of the Conception in Marseille, according to the protocol whose clinical trial authorization number is 2012 -000,374 to 36. The investigating physician clinical trials phase I-II a is Dr. Isabelle Ravaux.
Protocol clinical trial Protocol clinical trial underway
Phase I (completed successfully)
The preclinical toxicity macaque was made from 4 injections at a dose of 100 microgram and the observation period of 18 months on it to specify that no side effects were observed in the long term (Watkins & Al.2006).
Clinical trials were allowed January 25, 2013 by the National Security Agency of Medicines (MSNA) 48 PATIENTS SEROPOSITIVE and took place Hospital Clinical Investigation Centre of Design in Marseille.
This test is successful, the vaccine of the Supervisory Committee has authorized the company to spend BIOSANTECH in phase II.
Phase II (Ongoing)
It began Sept. 2, 2013 with the cessation of antiviral treatment for the first patient for 2 MONTHS. The objective of the II.a phase is to determine HOW MUCH IS THE MOST EFFECTIVE ON 48 PATIENTS VACCINATED
The objective of this phase is to check on a larger number of patients (80), the absence of adverse effects, the production of anti-Tat antibodies and undetectable viremia after 2 months of HAART stop.
At this stage, the goal is to have Biosantech intermediate results in early Q2 2014 and to review the benefits to patients by a vaccine or antiviral treatment from Tat Oyi.
If 30% of patients have antibodies able to cross-recognition against the Tat variants, and 30% of patients (vaccine group) hold viremia below 40 copies / ml after two months of interruption of antiretroviral therapy, test the BIOSANTECH AIDS vaccine according to UN standards.
Phase III OR « STUDY PIVOT »
As part of the testing of the vaccine according to the UN AIDS standards, this phase corresponds to the comparative study of actual effectiveness. It compares treatment with either placebo or a treatment important reference. No standard treatment, it may be because of issues benefit / risk of the development of a vaccine, this phase is very shortened under pressure from the country whose population is heavily contaminated.
The hypothesis BIOSANTECH
Vaccination of HIV patients, a synthetic active ingredient derived from varying « Tat Oyi » of HIV patients would help the immune system to recognize variants of the protein « Tat » in the blood. Neutralization of the « extra cellular Tat » protein would permit restoration of cellular immunity and elimination of cells infected with HIV-1. The decrease in infected cells should result in the stabilization of viremia in patients without the need for combination therapy. The evidence of efficacy of this vaccine is able to maintain a viremia below 40 copies / ml without using antivirals for two months. This vaccination would be a direct benefit for HIV patients, allowing them to have a normal social life and avoid heavy side effects of combination therapy.
The assumption is that vaccination with an active ingredient synthetically derived variant « Tat Oyi » of HIV-positive patients may help the immune system to recognize variants of the protein « Tat » in the blood. Neutralization of the « extracellular Tat » protein would restore cellular immunity and elimination of cells infected with HIV-1. For vaccinated patients, it could afford to maintain viremia 50 copies / ml without using antivirals. This vaccination would be a direct benefit for HIV patients.