Presented at the meeting
    
"HIV Vaccines for South-East and South Asia:
    
The Challenges and Opportunities"
    
Bangkok, 17-19 January 1996
    
    


    

    


    


      


      HIV Vaccine Development:
      
UNAIDS Perspectives
      


      


      J. Esparza, P. Piot

      

Joint United Nations Program on HIV/AIDS (UNAIDS),
      
Geneva, Switzerland.


      


    


    In view of the continuing spread of HIV infection worldwide, and of its devastating health and socioeconomic consequences, six organizations of the United Nations with complementary mandates and expertise (UNICEF, UNDP, UNFPA, UNESCO, WHO, and the World Bank) were brought together to form a cosponsored Joint United Nations Program on HIV/AIDS (UNAIDS). After a period of consultation and planning, UNAIDS became operational on January 1996.


    The mission of UNAIDS is to lead, strengthen and support an expanded response aimed at preventing the transmission of HIV, providing care and support, reducing the vulnerability of individuals and communities to HIV/AIDS, and alleviating the impact of the epidemic.


    


    Main focus of UNAIDS
    


    The main focus of UNAIDS is on strengthening national capability for an expanded response against the epidemic, by:

    


      

    • Identifying, developing and serving as a major source of international best practice, and promoting and supporting relevant research. "International best practice" consists of the principles, policies, strategies and activities that, according to collective experience from around the world, are recognized to be technically, ethically and strategically sound;

      


    • Catalysing and providing selected technical support targeted at strengthening national capability for an expanded response to HIV/AIDS, especially in developing countries;

      


    • Promoting a comprehensive, multisectorial response to HIV/AIDS, that is provided with adequate resources; and

      


    • Helping to coordinate and rationalize activities by the cosponsors and other United Nations bodies in support of the national response to HIV/AIDS.

    


    UNAIDS recognizes that better tools are urgently required to slow the expansion of the HIV epidemic and that a safe and effective HIV vaccine would be invaluable complement to other prevention strategies. The program will actively promote the development, evaluation and availability of appropriate HIV vaccines for worldwide use, especially in developing countries.


    The UNAIDS policy for HIV vaccine development will be developed through consultation, collaboration and strategic alliances with all partners, both in the public and in the private sector, using as starting point for discussion the "WHO Strategy for HIV Vaccine Development", formulated in 1990. Implementation of the strategy will be based on careful identification of the specific competence and roles of all partners, to coordinate and accelerate the development, evaluation and future availability of HIV vaccines.


    


    UNAIDS vaccine development policy:
    


    The guiding principles for the formulation of the UNAIDS policy and strategy for HIV vaccine development are:

    


      

    1. A recognition of the disparity between resources and needs in industrialized and developing countries. With more than 90% of all new HIV infections occurring in developing countries, these countries are in desperate need of better prevention methods, including a safe and effective HIV vaccine. However, the financial resources, the pharmaceutical industrial base, and most of the know-how and human resources needed to develop HIV vaccines are located in industrialized countries. UNAIDS will play an important role in bridging the gap between resources and public health needs for HIV vaccines in industrialized and developing countries;

      


    2. The participation of multiple partners (the scientific community, national and international AIDS research agencies, the pharmaceutical industry, private foundations, member states, and the affected communities) with changing roles as appropriate. The vaccine development "environment" has changed over time; Five years ago, the scientific community was more confident on the possibility of developing HIV vaccines, and numerous disincentives have decreased the interest of some pharmaceutical manufacturers in this area. However, non-governmental organizations and private foundations promoting HIV vaccines today are more active than five years ago. Very importantly, developing countries are becoming a leading force in the area of HIV vaccine development;

      


    3. Vaccine research must adhere to international best practice and norms, to ensure that trials are conducted to the highest scientific and ethical standards and with respect for human rights. UNAIDS will provide continuous scientific and ethical advice through international advisory groups, and a forum to discuss emerging and/or contentious issues, in order to base policy recommendations on the best scientific information available;

      


    4. There is an urgent need to move forward on HIV vaccine research. In the absence of a full understanding of the pathogenesis of HIV/AIDS and of immune correlates of protection, it is unlikely that vaccine trials will be conducted with full consensus of the scientific community. However, as part of its working culture, UNAIDS is prepared to take risks and to learn from both success and failure. In taking decisions about vaccine trials, UNAIDS will advocate for an appropriate balance between the theoretical and the empirical approach to vaccine development, after careful analysis of risk/benefit, scientific, logistical and public health considerations; 

      


    5. Vaccine research should have a long-term perspective, which will require
the formulation of a comprehensive product development strategy, including the
parallel development of different vaccine concepts. UNAIDS will continuously monitor and identify new opportunities for vaccine development and evaluation and will promote these activities by establishing strategic alliances with key partners;

      


    6. Capacity strengthening in developing countries, where vaccine development
activities are taking place, is essential for the long-term success of the strategy; and 

      


    7. International vaccine research should be conducted respecting national sovereignty of host countries. Trials must be discussed, approved, and conducted through the appropriate channels and institutions in the host country and final decisions will belong to the host country. UNAIDS will support and build on national actions. 

    


    


    Goals of the UNAIDS vaccine development strategy:
    


    In collaboration with its partners, and in accordance with the above principles, UNAIDS is designing and will implement a strategy with three main goals:

    


      

    • Vaccine development: Promoting the development and manufacture of candidate vaccines which are appropriate for developing countries (i.e., antigenically relevant to prevalent strains, easy to administer, capable of inducing long-term protection). This goal will be pursued through the systematic collection and characterization of HIV strains from different parts of the world (through the UNAIDS Network for HIV Isolation and Characterization). Virus strains and other reagents (such as molecular clones), as well as information generated through the Network, will be provided to vaccine scientists and to pharmaceutical manufacturers, to facilitate the development of appropriate candidate vaccines, and novel vaccine approaches (such as DNA immunization);

      


    • Vaccine evaluation: Facilitating the evaluation of appropriate candidate vaccines with the highest scientific and ethical standards. This goal will be pursued by strengthening national capabilities for HIV vaccine research, especially in developing countries, and by supporting targeted research in preparation for efficacy trials. Preparatory field research will include monitoring HIV variability at potential vaccine evaluation sites, development of cohorts of HIV negative volunteers and related social and behavioural studies, and repeat of Phase I/II (safety and immunogenicity) trials of selected candidate vaccines. It is envisaged that multiple efficacy trials of different HIV vaccine concepts, in different population groups, and in different countries, will be required before a safe and highly effective vaccine becomes generally available; and

      


    • Vaccine availability: Ensuring the availability of future HIV vaccines for public health use, especially in developing countries. This will pursued, first, by identifying and addressing potential disincentives for vaccine development (e.g., liability issues, regulatory bottlenecks) and, second, by planning well in advance strategies for future use and procurement of vaccines for developing countries, including negotiations with the pharmaceutical industry and potential funding/donor countries/agencies. 

      

    


    


    Selected Papers
    


    [1] ESPARZA J., OSMANOV S., KALLINGS L.O, and WIGZELL H. Planning for HIV vaccine trials: The World Health Organization perspective. AIDS, 5 (suppl 2), S159-S163, 1991. 


    [2] ESPARZA J., OSMANOV S., CLEMENTS M.L., and HEYMANN D. Preparation for efficacy trials of HIV vaccines: the role of the World Health Organization. In: Retroviruses of Human AIDS and Related Animal Diseases, 7th Colloque des "Cent Gardes". Edited by Girard M., Valette L. Marnes-La-Coquete, Paris. Fondation Marcel Merieux, 217-222, 1992. 


    [3] ESPARZA J. Development of WHO-sponsored sites for HIV vaccine evaluation. AIDS Res Hum Retroviruses, 9 (suppl 1), S133-S134, 1993.


    [4] ESPARZA J., OSMANOV S., HEYWARD W.L., and PIOT P. Ethical aspects of trials of candidate vaccines against the human immunodeficiency virus (HIV). In: Proceedings of the 4th International Seminar on Immunizations in Africa. Yamoussoukro, Cote d'Ivoire, 330-331, 1994. 


    [5] ESPARZA J., HEYWARD W.L., and OSMANOV S. HIV vaccine development: from basic research to human trials. AIDS, 10 (suppl A), in press, 1996. 


    [6] OSMANOV S., HEYWARD W.L., and ESPARZA J. The World Health Organization Network for HIV Isolation and Characterization: summary of a pilot study. AIDS Res Hum Retroviruses, 10, 1325-1326, 1994.


    [7] WORLD HEALTH ORGANIZATION. Scientific and public health rationale for HIV vaccine efficacy trials. AIDS, 9, WHO1-WHO4, 1995.