Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials

Abstract

IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.

An Exploratory Analysis of Human Immunodeficiency Virus (HIV) Prevalence in Nigeria

“…Without treatment, HIV can progress to Acquired Immunodeficiency Syndrome (AIDS), a condition characterized by severe immune system impairment. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), approximately 38 million people worldwide were living with HIV at the end of 2020 [1].…”

“…Sub-Saharan Africa has been disproportionately affected by the HIV epidemic, accounting for approximately two-thirds of the global HIV infections. In this region, southern and eastern African countries have been particularly hard hit, with prevalence rates among the highest in the world [1].…”

“…Despite significant progress in preventing new infections and expanding access to treatment, certain populations continue to face higher risks. Among them are key populations such as men who have sex with men, people who inject drugs, sex workers, transgender people, and prisoners [1]. Moreover, women and girls bear a disproportionate burden of HIV, particularly in sub-Saharan Africa.…”

“…Moreover, women and girls bear a disproportionate burden of HIV, particularly in sub-Saharan Africa. In this region, young women aged 15-24 are significantly more likely to acquire HIV compared to their male counterparts [1]. Additionally, HIV prevalence among children remains a concern, with an estimated 160,000 new infections occurring among children under the age of 15 globally in 2020 [1].…”