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A Globally Effective HIV Vaccine Requires Greater
Participation of Women and Adolescents in Clinical Trials
Press
Release WHO/UNAIDS N°59
31 August
2004
Geneva - Greater participation of women and adolescents is
needed in HIV vaccine clinical trials, according to a group of international
experts, who attended a consultation on HIV vaccine trials in Lausanne,
Switzerland, from 26-28 August.
The meeting, organized by
the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS), brought together for the
first time 40 experts from around the world to address the issues of gender
and age in particular, as well as race in HIV vaccine-related research and
clinical trials.
"We have identified
measures aimed at rectifying the injustice stemming from the frequent
exclusion or low participation of women and adolescents in HIV vaccine
clinical trials. Clinical trial enrolment needs to be more inclusive, so the
benefits of research are more fairly distributed," said Dr Ruth Macklin,
co-Chair of the meeting and a bioethics professor at the Albert Einstein
College of Medicine in New York city.
Studies show that women,
when exposed to HIV, are at least twice as likely to become infected with HIV
as their male counterparts. In parts of sub-Saharan Africa, girls and young
women are up to six times more likely to be infected than their male peers.
Girls and young women aged 15-24 make up 62% of the young people in
developing countries living with HIV or AIDS. "Women and girls are
particularly vulnerable to HIV infection for biological, social and economic
reasons," said Dr Catherine Hankins, Chief Scientific Advisor at UNAIDS,
who spoke at the opening of the meeting.
Youth and young adults are
also at high risk for HIV: about half of new HIV infections in the developing
world occur among 15 to 24 year olds.
"In spite of the
epidemiological reality, women and adolescents, especially girls, have often
had minimal involvement in clinical trials of HIV vaccines, as compared to
men. This is in spite of the fact that they would be major beneficiaries of a
future HIV vaccine," said Dr Saladin Osmanov,
Acting Coordinator, WHO-UNAIDS HIV Vaccine Initiative, WHO. The Initiative
promotes the development of an HIV vaccine, including through the
facilitation of clinical trials.
Reasons for the lack of
participation of women and young people in HIV vaccine clinical trials to
date are numerous and include: lack of empowerment, independent
decision-making and education in some settings; social isolation;
discrimination; pregnancy and the potential effects of a candidate vaccine on
a foetus; stigma associated with high-risk behaviour; trial enrolment criteria; and issues concerning
confidentiality and informed consent. For instance, the participation of a
minor in a clinical trial would require the parents' or guardian's consent,
and youth must fully understand what receiving a candidate HIV vaccine does
or does not mean for their health.
Experts agreed that these
obstacles could and should be overcome because HIV vaccines need to be tested
in a heterogeneous population, particularly in those most in need of a
vaccine. Vaccines for several infectious diseases have shown varying levels
of efficacy in different gender, age and racial or ethnic sub-groups. The
1998-2003 trial of VaxGen's AIDSVAX, the only
candidate vaccine so far to reach Phase III efficacy testing in large numbers
of people, found that although the vaccine was not effective overall,
non-whites and women possibly had some degree of protection. This
finding merits further investigation.
More than 30 promising, new
candidate HIV vaccines are currently being tested in human clinical trials,
the majority of which began in the past four years. The number of AIDS
vaccine candidates in small-scale human trials has doubled since 2000. The
trials are taking place in 19 countries. A safe, effective and affordable
vaccine against HIV would be a powerful arm against the AIDS epidemic which
continues to infect five million adults and children and kill three million
people every year.
The international HIV
vaccine research mission is to develop HIV vaccines that are licensed,
acceptable, available and accessible by all populations regardless of their
gender, age, socio-economic status, race, ethnicity or country, and that are
effective across the board. Special attention must be paid to ensure that
vulnerable groups, particularly women and girls, benefit from an HIV vaccine.
Recommendations--covering
ethics, policy, advocacy, community participation, clinical trial design and
research gaps--issued at the consultation will form the basis of a policy
document that will help guide those designing and conducting HIV vaccine
clinical trials. An important suggestion for future work was to study HIV
clinical trial sites with enrolments that include appropriate numbers of
people from different sub-groups, and to try to better understand the
barriers that have prevented wider participation.
The challenges to the
creation of an HIV vaccine are mainly scientific and economic, primarily due
to the lack of incentive by the private sector to engage in product
development. However, new momentum has been generated in the field of HIV
vaccine research. In June this year, the G8 countries endorsed a Global HIV
Vaccine Enterprise to accelerate efforts to develop an HIV vaccine through an
expanded capacity to test and manufacture vaccines, the establishment of
vaccine development centres around the world and
the development of an integrated global clinical trials system allowing
laboratories to easily share data.
Represented at the
consultation, co-sponsored by WHO and UNAIDS, were
governmental public health research institutions in developing and industrialized
countries, medical schools, industry, foundations and non-governmental
organizations.
For further information,
please contact Melinda Henry, Information Officer, Immunization, Vaccines and
Biologicals Department, World Health Organization,
Geneva; Tel.: +41 22 791 2535, mobile +41 79 477 1738, email: henrym@who.int; or Dominique de Santis, Communications Officer, Joint United Nations Programme on HIV/AIDS, Geneva; Tel.: +41 22 791 4509, mobile: +41 79 254 6803, email: desantisd@unaids.org.
All WHO Press Releases,
Fact Sheets and Features as well as other information on this subject can be obtained on Internet on the WHO home page: http://www.who.int
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