vaccine HIV

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HIV Vaccine Research Vaccine development remains the #1 priority of AIDS research. It is the best hope for protection against HIV infection.

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HIV Lifecycle T Cell CD4

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What is a vaccine? A vaccine is a medical product designed to stimulate your body's immune system in order to prevent or control an infection

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Therapeutic HIV vaccines are designed to control HIV infection in people who are already HIV positive. . Preventive HIV vaccines are designed to protect HIV negative people from becoming infected or getting sick.

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main types of vaccines Subunit vaccines, ("component" or "protein" vaccines) Contain only individual parts of HIV, rather than the whole virus. , Recombinant vector vaccines Non-HIV viruses that either don't cause disease in humans are used as vectors, or carriers, to deliver copies of HIV genes into the cells of the body. DNA vaccines “Naked" DNA containing HIV genes is injected directly into the body.

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HIV Vaccine Approaches

Scientific Challenges in AIDS Vaccine Development : 

HIV is a retrovirus HIV does not induce protective immunity HIV is hyper variable HIV has immune evasion mechanisms HIV infects humans Scientific Challenges in AIDS Vaccine Development

Phases of clinical trial : 

Phases of clinical trial

Ideal Pipeline for HIV Vaccine Development : 

Ideal Pipeline for HIV Vaccine Development Vaccine Constructs Vaccine Concepts Vaccine Clinical Trials Money People Laboratory and animal resources Money People Resources Regulatory approval

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HIV Vaccines: Current Pipeline Situation # GMP lots made Vaccine Constructs in Concept Stage # Entered Phase I # Entered Phase II # Entered Phase III

Key Findings in AIDS Vaccine Design and Development : 

Key Findings in AIDS Vaccine Design and Development FIRST WAVE 1986-1994 CD4 identified as the primary host cell receptor for HIV First clinical trial of an AIDS vaccine candidate. Prime-boost vaccination strategy for HIV proposed First-generation Env-based vaccines elicit antibodies that neutralize laboratory adapted HIV strains but not circulating primary isolates First AIDS vaccine trials in the developing world conducted

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Between 1987 and 2000 over 20 different HIV vaccine products tested Trials involved over 5,000 subjects Trials conducted in U.S., Thailand, China, Kenya, and Europe One subunit vaccine advanced to phase 3 trials

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SECOND WAVE 1995-2007 Broadly neutralizing monoclonal antibodies against HIV identified CCR5 identified as co-receptor for HIV First efficacy trial of Env-based vaccine fails to protect against HIV infection or suppress viral load Structures of broadly-neutralizing monoclonal antibodies bound to Env determined Efficacy trial of leading vaccine candidate designed to elicit CMI responses shows no evidence of effectiveness

WHO-UNAIDS HIV Vaccine Initiative : 

WHO-UNAIDS HIV Vaccine Initiative The mission is “to promote the development, facilitate evaluation, and address future availability of preventive HIV vaccines, with a focus on the need of developing countries.” UNAIDS contributes with its expertise in social and behavioural research, ethical issues, political mobilization and its strong link with community; WHO brings its experience in vaccinology, especially in product development, vaccination strategies and its established public-private sector partnership in the development and delivery of a wide range of vaccines for public health prevention programmes

IAVI: International AIDS Vaccine Initiative : 

IAVI: International AIDS Vaccine Initiative A global not-for-profit organisation working to speed the search for a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 23 countries. IAVI also advocates for a vaccine to be a global priority and works to assure that a future vaccine will be accessible to all who need it

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In December 2000,Govt. Of India through MHFW entered into a Memorandum of Understanding (MoU) with the IAVI to develop an AIDS vaccine to prevent HIV infection & AIDS. The tripartite agreement is between the NACO; ICMR & IAVI In an effort to expand the scope of the AIDS vaccine programme in India, IAVI also collaborate with Ministry of Science and Technology, Department of Biotechnology & Council of Scientific and Industrial Research to capitalise on opportunities of world-class applied research on AIDS vaccines within the country.

AIDS Vaccine Candidates in Clinical Trials : 

AIDS Vaccine Candidates in Clinical Trials

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Clinical trials in India : 

Clinical trials in India Two vector based clinical trials TBC-M4 Trial in Chennai With Tuberculosis Research Center Chennai & NARI Pune MVA based potential AIDS Vaccine TBC-M4 MVA Used a vehicle for six HIV-1 subtype C genes Entered in phase III

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tgAAC09 A Phase I trial was initiated on February 7, 2005 at the NARI, Pune and was completed in December 2006 Non-pathogenic adenoviruses is vector Used as a vehicle for gag, protease and part of the reverse transcriptase genes of HIV-1 Subtype C

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STUDY RESULTS OF VARIOUS VACCINE TRIALS

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. V520 contains a weakened adenovirus that serves as a carrier for three subtype B HIV genes (gag / pol / nef). Because the vaccine contains only three HIV genes housed in a weakened adenovirus, study participants cannot become infected with HIV or get a respiratory infection from the vaccine. It was announced in September 2007 that the trial for V520 would be discontinued after it determined that the vaccination was ineffective.

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References www.who.int.in www.iavi.in International AIDS Vaccine Intuitive (2008). AIDS v vaccine Blueprint 2008 Johnston MI, Fauci AS. (2007)An HIV vaccine – evolving concepts. N Engl J Med;356:2073-2081. Letvin, N.L. 2006. Progress and obstacles in the development of an AIDS vaccine. Nat. Rev. Immunol. 6:930–939. Markel H., (2005) The search for effective HIV vaccines, N Engl J Med 353, pp.753–757. Walker, B. D., Burton, D. R. (2008). Toward an AIDS Vaccine. Science 320: 760-764