India

Indian woman from a community organization in Chennai, India

With a rich pool of scientists and medical professionals, and a thriving pharmaceutical industry, India has the potential to play a leading role in AIDS vaccine research and development.

To tap this potential, IAVI signed in December, 2000, a memorandum of understanding with the Government of India’s Ministry of Health and Family Welfare, which was represented by the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO). In September, 2001, we opened an office in Delhi to oversee our vaccine development efforts in the country.

IAVI’s work in India encompasses everything from advocacy to the clinical development of candidate AIDS vaccines. We are also engaged in vaccine design research in partnership with the Indian government and a variety of corporations.

We work with several partners in India, including:

ICMR: The Council, a government institution, is responsible for the formulation, coordination and promotion of all biomedical research in India

NACO: A division of the Ministry of Health and Family Welfare, NACO oversees the formulation of policies and implementation of programs for the prevention and control of HIV/AIDS in India
National AIDS Research Institute (NARI): An institute overseen by the ICMR and based in Pune, Maharashtra, NARI has a mandate to provide leadership in research on HIV infection and AIDS. In February, 2005, this research center enrolled 30 volunteers in India’s first AIDS vaccine trial. Though the candidate vaccine was safe and well tolerated, it proved to be only moderately immunogenic
Tuberculosis Research Center (TRC): Headquartered in Chennai, TRC was set up by the ICMR in 1955 to boost biomedical research in India. TRC too conducted a Phase I trial of the candidate AIDS vaccine assessed by NARI. Both TRC and NARI are currently preparing to launch a second Phase I clinical trial
Department of Biotechnology (DBT): IAVI signed a Memorandum of Understanding with DBT in July 2005 to participate in the research, development and evaluation of AIDS vaccines primarily for use in India. Our collaboration with DBT, a division of the Ministry of Science and Technology, covers research toward the discovery of novel AIDS vaccines, building technical capacity for vaccine trials in India, exchanging information on AIDS vaccine research and addressing intellectual property issues to facilitate licensing and technology transfer agreements

Y R Gaitonde Centre for AIDS Research and Education (YRG Care): A non-profit organization in Chennai, Tamil Nadu, YRG Care is involved in AIDS-related treatment and care, advocacy, clinical and social research, community outreach and HIV prevention and education. We partner with YRG Care to support community education and mobilization around AIDS vaccine research studies

The Naz Foundation (India) Trust: Based in New Delhi, The Naz Foundation is a community-based organization working on HIV prevention in India. It has a service delivery network that promotes awareness about HIV, and provides care and support for those infected with or otherwise affected by the virus. We partner with The NAZ Foundation to work with marginalized populations and to build understanding of gender issues in the HIV crisis

VACCINE DESIGN

IAVI and DBT launched in 2007 the Indian Medicinal Chemistry Program, a collaboration between IAVI’s scientists and those at academic and corporate labs in India that is chiefly dedicated to generating and testing novel concepts in AIDS vaccine design. The partnerships include the following institutions:

International Centre for Genetic Engineering and Biology, for the design and generation of conceptually novel immunogens for an AIDS vaccine
Indian Institute of Science, for the design and generation of conceptually novel immunogens for an AIDS vaccine
Chembiotek, a contract research organization, for the industrial-scale synthesis of novel small molecule compounds, including those required for the Medicinal Chemistry Initiative
Strand Life Sciences for the computational design of novel immunogens for an AIDS vaccine

BUILDING TECHNICAL CAPACITY

To ensure the long-term viability of the clinical trial programs in which we participate, we stress the cultivation of technical capacity at the research centers where we conduct biomedical research.

In line with that policy, IAVI has supported the training of NARI and TRC researchers in Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).

SUPPORTING TRIALS

IAVI has collaborated with NARI to establish a community center at the Institute’s Vaccine Trial Center to improve public understanding of AIDS vaccine trials and support the recruitment of volunteers. Here, information about HIV and participation in vaccine-related research is shared with potential volunteers. The center also trains community outreach workers and hosts a community advisory board (CAB), which provides crucial input on the informed consent processes during volunteer recruitment.

As part of the TRC Vaccine Trial Center’s clinical program, counselors provide voluntary counseling and testing for HIV (VCT), as well as information about AIDS vaccines and participation in research. TRC and IAVI partner with YRG CARE, which has already established a CAB for AIDS-related research.

Working with an array of experts in India, IAVI began addressing in 2002 the critical gender issues that are likely to arise during AIDS vaccine trials. The effort generated a curriculum to train research staff to address gender-related issues that have an impact on volunteer participation in clinical trials as well as the conduct of those trials. This training was completed before the vaccine trials were started.

REACHING OUT

The AIDS vaccine effort would not be sustainable without the widespread support of communities where vaccine trials are conducted.

With that in mind, we helped to convene a National Advisory Board consisting of independent experts in a variety of fields—from medicine to sociology—and representatives of national and international agencies to advise AIDS vaccine research and development efforts in India. We also established an Informed Consent Group in India. Its task was to develop a culturally appropriate template of the informed consent document that is required for the ethical recruitment of volunteers in vaccine trials.

IAVI supported the creation of the National Coalition on Health Initiatives (NCHI), a national network of NGOs that have close ties to the communities with which they work. Such organizations can play a vital, supportive role in activities related to heath care, whether they involve the provision of services, advocacy or the recruitment of volunteers to clinical research. IAVI partners with NCHI to build grassroots support for AIDS vaccines by disseminating information on the subject and its associated issues to regional NGOs. Members of this network include YRG CARE, NAZ (India) Foundation Trust, Freedom Foundation, SOS Foundation, AIDS Prevention Society, and Indian Network for Positive People Living with HIV/AIDS.

We have also, since 2001, distributed a bimonthly newsletter, SANKALP, that highlights issues related to AIDS vaccine research and reports on the latest developments in HIV prevention in India. It has a readership of more than 7,000, and is published in Tamil, Marathi, and English.

Finally, we work with a variety of organizations in India to access high risk populations, research the impact of gender on clinical trials and incorporate those lessons in our vaccine development program. For example, in partnership with local organizations and the Population Council, an international NGO, IAVI explored ways to engage communities of men who have sex with men and transgendered persons in AIDS vaccine research. The research study was conducted in four sites in three high-prevalence states of India: Chennai and Madurai in Tamil Nadu, Hyderabad in Andhra Pradesh, and Mumbai in Maharashtra.

CULTIVATING POLITICAL SUPPORT

High-level political support and sound policy are also essential to the sustainability of the AIDS vaccine effort.

As we do elsewhere, we have developed a systematic strategy to educate civil society and political leaders about HIV vaccines and support sound policies in the arena of HIV prevention and treatment. Leaders across the political spectrum in India have expressed support for both IAVI and its objectives. We sustain this backing through regular briefings and conferences with policymakers and government officials. Such consultations helped generate recommendations that were adopted into the larger framework of the Indian government’s HIV/AIDS care and treatment policy guidelines.

In 2007, IAVI completed three pieces of policy research focused on AIDS vaccine research and development and future access to effective AIDS vaccines in India. Together, these projects illustrate how policy change could benefit a range of AIDS vaccine activities: accelerating research and development, stimulating future market demand and addressing potential delivery issues. We are sharing these results with policy-makers.

ADVOCACY

Engaging country leaders at the highest level is a cornerstone of IAVI’s effort to advance the Global Political Advocacy Initiative (GPAI), which advocates for sound public policies to accelerate the development and distribution of AIDS vaccines. In 2006, at the first India-Brazil-South Africa (IBSA) Summit, leaders of the three nations agreed to enhance trilateral cooperation and support collaborative actions to bolster research and development for AIDS vaccines.

Learn More

Visit the IAVI India website