IAVI and Indian Government Announce Results of Phase I AIDS Vaccine Trial

India Continues to Progress in AIDS Vaccine Development Efforts

Phase I clinical trial of a preventive vaccine shows encouraging outcome

Chennai, August 16, 2008 – A second Phase I AIDS vaccine clinical trial in India was successfully completed, the Indian Council of Medical Research, the National AIDS Control Organization and the International AIDS Vaccine Initiative announced. The results of the trial of an MVA-based AIDS vaccine candidate (TBC-M4), which was conducted in Chennai, indicated that the vaccine candidate had acceptable levels of safety and was well tolerated.

The proportion of volunteers whose immune systems responded to the vaccine candidate suggests the candidate holds promise. The trial was done using two doses of the candidate vaccine. After three injections, 82 percent of the volunteers who received a low dose and 100 percent of those who received a high dose registered immune responses to the vaccine. The 100 percent response rate is greater than that seen with the majority of AIDS vaccine candidates tested in humans to date. However the strength and diversity of these immune responses were modest. It may be possible to boost the immune response, if this vaccine is used in combination with other candidate AIDS vaccines.

“We are pleased to see that the MVA-based candidate tested in Chennai was safe and showed promising initial immune responses. We do not know whether these observed responses will ultimately translate into an effective vaccine that will help protect individuals from HIV infection, but hope to learn more through further testing,” said Dr. S K Bhattacharya, Additional Director General of the Indian Council of Medical Research. “India is playing a significant role in global AIDS vaccine discovery efforts given our strong medical and scientific capabilities. There is a need for continued efforts for the creation of novel, reliable mechanisms for long-term research on AIDS vaccines and other new prevention technologies.”

The Phase I clinical trial was initiated in January 2006 at the Tuberculosis Research Center (TRC), an Indian Council of Medical Research (ICMR) institute in Chennai, and was completed in February 2008. This trial was conducted under the aegis of a Memorandum of Understanding (MoU) between the Government of India—through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO)—and the not-for-profit International AIDS Vaccine Initiative (IAVI). YRG CARE, based in Chennai, collaborated with TRC to mobilize the community around the Phase I trial.

Dr. Narayanan, former Director of the Tuberculosis Research Center, added, “Consistent innovation in science despite setbacks has ensured the development of many effective prevention technologies. The successful conduct of the trial in Chennai re-affirms the need for continued vaccine development initiatives, where learnings from every effort will contribute to global advancement of the AIDS vaccine field.”

About the Phase I MVA-based (TBC-M4) AIDS vaccine trial

The trial was a double blind, dose-escalation, randomized, placebo-controlled trial, which was initiated after receiving all necessary regulatory and ethical clearances. The objectives of such a Phase I trial are to evaluate the safety of the vaccine candidate and to gather preliminary results of immune responses induced by the candidate. The total duration of the trial was approximately 24 months. The volunteers recruited for this trial were 32 healthy, HIV-uninfected men and women between 18 and 50 years of age, from all socio-economic strata. Three intra-muscular injections of TBC-M4 or placebo were administered to the volunteers.

Moving forward

The results of the Phase I vaccine trial of TBC-M4 suggest that further research is warranted. Currently, two additional Phase I trials testing the MVA-based candidate in a prime-boost regime are planned and under review by the relevant authorities in India and approved in the UK.  The trials are designed to use different modes of administration of the priming vaccine, different dosages and different vaccine regimens. It is hoped that the prime-boost regimen will help to strengthen the modest immune responses observed in the Phase I trial of the MVA-based candidate alone. Collectively, the results will help determine whether and how to move forward with additional testing of this MVA-based AIDS vaccine candidate.

Simultaneously, IAVI has undertaken work to modify the MVA-based vaccine candidate so that it is ready for large-scale manufacturing should the trial results suggest further testing is warranted.

Fact Sheet

Phase I clinical trial- TBC M4:

• Was initiated in January 2006 and completed in February 2008.
• The vaccine candidate, TBC-M4, is based on a vector built from recombinant Modified Vaccinia Ankara (MVA). It was designed by a biotech firm in the U.S. in collaboration with Dr. Sekhar Chakrabarty from the National Institute of Cholera and Enteric Diseases (NICED). It targets HIV-1 subtype C, the most predominant HIV subtype in India.
• A Phase I trial is the first human test of a candidate vaccine for evaluation of safety, and to a lesser extent, analysis of the immune responses evoked by the vaccine, different vaccine doses and immunization schedules.
• The trial was conducted under the aegis of a MoU between the Government of India—through ICMR and NACO—and IAVI.About Partners

About the National AIDS Control Organization (NACO):

NACO is the nodal organization for formulation of policy and implementation of programmes for prevention and control of HIV/AIDS in India. The overall vision of the National AIDS Control Organization (NACO) is to lead and catalyze an expanded response to the HIV/AIDS epidemic in order to contain the spread of infection, reduce people’s vulnerability to HIV, promote community and family-based care to HIV/AIDS cases within an enabling environment without any stigmatization and discrimination, and alleviate the epidemic’s devastating social and economic impact.

About the Indian Council of Medical Research (ICMR):

The ICMR, the apex body in India for the formulation, co-ordination and promotion of biomedical research, having been founded in 1911, is one of the oldest medical research bodies in the world.

The Governing Body of the Council is presided over by the Union Health Minister. It is assisted in scientific and technical matters by a Scientific Advisory Board comprising eminent experts in different biomedical disciplines. The Board, in turn, is assisted by a series of Scientific Advisory Groups, Scientific Advisory Committees, Expert Groups, Task Forces and Steering Committees, which evaluate and monitor different research activities of the Council.

About the Tuberculosis Research Centre (TRC):

TRC, headquartered in Chennai, was set up in 1955 by the ICMR to boost biomedical research in India and to complement the National Tuberculosis Control Programme. In recent years, TRC has been extensively involved in HIV research. The institution has one of India’s best and most experienced multidisciplinary teams of scientists and one of the best-equipped laboratories for HIV/AIDS and tuberculosis research.

About the Y R Gaitonde Centre for AIDS Research and Education (YRG Care):

YRG Care is a non-profit HIV referral and research centre in Chennai. The centre was founded in 1993 by Dr. Suniti Solomon M.D., who documented the first evidence of HIV infection in India. YRG CARE is a widely recognized model of AIDS care and support services. YRG CARE has established a comprehensive platform for HIV diagnostic, laboratory and clinical facilities that are unparalleled in the country. The centre has developed an extensive network of local, national and international collaborators. The centre has a commendable track record in excellence in program implementation and research.

About the International AIDS Vaccine Initiative (IAVI):

IAVI is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates.  IAVI’s financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There’s A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world.  For more information, see www.iavi.org.

For further information, please visit the IAVI India website – www.iavi.org.in