With women at least twice as likely to become infected with HIV as men when exposed to the virus that causes AIDS – and six times as vulnerable in parts of sub-Saharan Africa – HIV vaccine clinical trials must be geared towards meeting their needs, the United Nations health agency said Tuesday.
– 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 Saladin Osmanov, Acting Coordinator of the HIV Vaccine Initiative of the World Health Organization (WHO) and the Joint UN Programme on HIV/AIDS (UNAIDS).
Reasons women are not covered include their lack of empowerment and education as well as prevailing discrimination, according to a meeting of 40 international experts organized by WHO and UNAIDS in Lausanne, Switzerland, last week on vaccine research for the epidemic which infects 5 million people and kills 3 million every year.
Pregnancy and the potential effects of a candidate vaccine on a foetus, and stigma associated with high-risk behaviour also play a role.
– 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, Ruth Macklin, co-Chair of the meeting and a bioethics professor at the Albert Einstein College of Medicine in New York, told the gathering convened to address issues of gender, age and race in HIV vaccine-related research and clinical trials.
– Clinical trial enrolment needs to be more inclusive, so the benefits of research are more fairly distributed, she added. Girls and young women aged 15-24 make up 62 per cent of young people in developing countries living with HIV or AIDS.
Recommendations included choosing trial sites with enrolments that include appropriate numbers of people from different sub-groups and trying to better understand the barriers that have prevented wider participation.
– Women and girls are particularly vulnerable to HIV infection for biological, social and economic reasons, Catherine Hankins, Chief Scientific Advisor at UNAIDS told 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.
More than 30 promising new candidate HIV vaccines are currently being tested in 19 countries, double the number of four years ago.
While there has been a lack of incentive by the private sector to engage in product development, in June the Group of Eight (G-8) leading industrial countries endorsed a global plan to accelerate the effort.
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