IAVI

IAVI develops vaccine candidates and other biomedical innovations and manages clinical research with partners in academic, biotechnology, pharmaceutical, and government institutions. IAVI also provides translational research services and support to other organizations in the field, assisting them with the complex process of transitioning innovations from the laboratory into clinical trials. This includes providing assistance with manufacturing protocols and clinical and regulatory filings.

Product Development Center
In 2013, the Bill & Melinda Gates Foundation (BMGF) awarded a grant to IAVI to create the Vaccine Product Development Center (VxPDC) to assist investigators affiliated with BMGF’s Collaboration for AIDS Vaccine Discovery with the complex process of transitioning vaccine candidates from the laboratory to the clinic. Subsequently, IAVI expanded the Product Development Center (PDC) in recognition of efforts beyond vaccines and extending this translational expertise to other partners — whether academic, nonprofit, government, or industry — that are advancing new biomedical interventions. The PDC fills a critical gap in the development process for new vaccines and other biomedical innovations. Today, investigators from the U.S. National Institutes of Health and European funding partners are among those who utilize IAVI’s PDC.


The PDC provides:
- A team of pharmaceutical development experts who collectively have advanced hundreds of projects through global regulatory agencies.
- An extensive network of Contract Research Organizations, Contract Manufacturing Organizations, and technology partners to accelerate development and minimize risk.
- Access to clinical research networks around the world, including in Africa and India.
- Over 20 years of HIV vaccine development experience from projects using a wide range of technology platforms.

IAVI conducts clinical trials, observational epidemiology, and socio-behavioral research that informs the design of vaccine candidates and other prevention modalities. This work also provides important data for future efficacy trials to prevent HIV and other diseases of global public health significance. IAVI works with academic, government, foundation, and community-based partners to conduct this research.

IAVI’s network of clinical research partners in sub-Saharan Africa, India, and the U.K. play a central role in our clinical research.

IAVI supports the development of in-country scientific and technical expertise and leadership needed to conduct research at the highest ethical and scientific standards. IAVI also implements the concepts of Good Participatory Practice Guidelines to ensure community engagement throughout the research process.

IAVI’s key clinical research activities:
- Test novel vaccines and antibodies from preclinical research through Phase I-III clinical trials. This includes products against HIV, SARS-CoV2, tuberculosis, Lassa fever, snakebite, and others.
- Prepare to execute efficacy trials in at-risk populations through supportive epidemiology and capacity building, as well as stakeholder and community engagement.
- Develop in-country scientific capacity and leadership in the HIV research field, including HIV vaccine design and development through a wide range of collaborative and education programs.

IAVI advocacy work engages policymakers, scientists, activists, civil society organizations, influencers, community representatives, and stakeholders across the world to ensure that necessary resources and policies can sustain local, regional, and global support for vaccine development and new biomedical prevention approaches. IAVI recognizes that these approaches must reflect regional realities and priorities essential to ending AIDS, tuberculosis (TB), and emerging infectious diseases (EIDs) as well as addressing other unmet global health challenges. IAVI’s advocacy partners — from the community to the global level — mobilize a comprehensive response to disease prevention while ensuring decision-makers have the information and evidence to make informed choices about supporting global health solutions. This work has forged the path for HIV vaccines to be listed as national health research priorities in many countries where the organization works. IAVI, in partnership with the Uganda AIDS Commission, has also developed guidelines and a road map for delivering HIV and AIDS services in vulnerable Ugandan fishing communities. These national commitments translate into increased domestic support for strengthening research and regulatory facilities, as well as inclusive and effective health policies.

IAVI’s careful and informed approach to community engagement is essential to conduct safe and ethical HIV, TB and EID research in a way that avoids the potential for social harm such as discrimination, gender-based violence and stigma to study participants, especially those most vulnerable, including adolescent women and young girls, men who have sex with men, transgender women, and fishing communities. The IAVI model for community engagement continues to demonstrate that many marginalized and vulnerable communities are accessible and, with careful outreach initiatives, are eager to participate in potentially lifesaving scientific research. Activities such as India’s experiential learning, interactive theatre, and creative arts-based approaches demystify clinical trials for potential participants. Such work is essential for ensuring a fully informed and balanced representation of key populations in clinical trials.