Table 1.

Stakeholders Domains and Rationale of Engagement in HIV Vaccine Development

Stakeholder	Examples (nonexhaustive)	Domains and rationale of engagement
International agencies	WHO, UNAIDS, World Bank	Catalyzer for National HIV Vaccine Development Plan, HIV Vaccine Advisory Committee, advocacy, policy and guidelines, monitoring & evaluation, expert review committees and working groups, ad hoc review of clinical trial proposals, normative communication of scientific results, continuum of engagement across stakeholders, health economy studies (in particular in low- and middle-income countries)
Scientific community	Academic institutions (US NIH VRC, HIV Vaccine Working Group and the AIDS Research Advisory Committee), BMGF, MHRP, CDC, HVTN, UK MRC), Global HIV Vaccine Enterprise, research agencies (IAVI, KAVI, SAAVI, EuroVacc, ANRS, ICMR), African AIDS Vaccine Programme, Institutional scientific advisory committees	Drive the global scientific agenda and tailor the agenda to country and/or regional needs. Implement clinical trials, generate and communicate results Monitor the HIV epidemic and contribute to the establishment of national guidelines and National HIV Vaccine Development Plans Are in constant interaction with all stakeholders at all levels
Funding agencies and constituencies	US NIH, USAID, BGMF, US Army, ANRS, AFPPD, European Community, Governments, private donors	Key stakeholders whose contribution is essential to the conduct of the overall HIV vaccine development agenda
Public health and regulatory agencies	US NIH, Ministry of (Public) Health, country-specific regulatory authorities (e.g., US FDA, EMA, Thai FDA, South African Health Products Regulatory Authority, NACO, China FDA)	Tailor the scientific agenda to the country-specific HIV epidemic and community needs. Ensure that the products tested comply with national regulations. Responsible for national policy and deployment strategies Are in constant dialogue with the scientific community and other stakeholders for discussions and requirements on licensure and access
Civil society	People living with HIV (PLHIV), key populations, advocacy groups (AVAC, IAVI), CAB, NGO, Ethics Committees, Institutional Review Boards, Legal groups	Contribute to a broad range of activities from advocacy, human rights, ethics and legal considerations, and represent the key interface with the scientific community Convey expectations and concerns from the public targeted for HIV vaccine trials and deployment Key stakeholders for the recruitment and follow-up of volunteers for clinical trials
Pharmaceutical industry	Sanofi Pasteur, Novartis, Merck, GlaxoSmithKline, GSID, Biotech companies, CMOs	Contribute to the design of the scientific agenda, manufacture and supply products to be tested in humans and work on access and licensure with national public health and regulatory authorities
Media	Newspapers, TV, radio, internet, newsletters	Relay general scientific findings to the public and convey expectations and concerns Can positively contribute to global, regional and national HIV vaccine advocacy and conversely mislead public opinion

ANRS, Agence Nationale de Recherche sur le Sida, France; AVAC, Global Advocacy for HIV prevention; BMGF, Bill & Melinda Gates Foundation; CAB, Community Advisory Board; CDC, Centers for Disease Control and Prevention, USA; China FDA, Food and Drug Administration; CMOs, Contract Manufacturing Organizations; EMA, European Medicines Agency; FDA, US Food and Drug Administration; GSID, Global Solutions for Infectious Diseases; HVTN, HIV Vaccine Trials Network; IAVI, International AIDS Vaccine Initiative; ICMR, Indian Council of Medical Research, India; KAVI, Kenya AIDS Vaccine Initiative; MHRP, US Military HIV Research Program; NACO, National AIDS Control Organisation, India; NGO, Nongovernmental organization; NIH VRC, National Institutes of Health, Vaccine Research Centre; SAAVI, South Africa AIDS Vaccine Initiative; UK MRC, United Kingdom Medical Research Council.