Despite progress in the treatment and prevention of HIV – which has caused 35 million deaths since the early 1980s – there remains a pressing need for a preventive vaccine to help end the global pandemic. In this insight brief, IQVIA experts apply the company’s extensive experience in HIV, including 61 global treatment and prevention studies at 2,284 sites, and involving 30,170 subjects, to describe progress towards vaccine development. Areas of focus include the four vaccine concepts that have been tested; ongoing trials; lessons learned; and avenues of future research.
The IQVIA experts summarize recent advances in the immunopathology of HIV, encouraging new developments in vaccine research, and the very limited status of pediatric studies. They also examine the impact of pre-exposure prophylaxis (PrEP) on vaccine trials, and the role of innovative and efficient approaches such as adaptive clinical trial design.
There has been great progress in the treatment and prevention of human immunodeficiency virus (HIV) in the three decades since its discovery, with the rate of new infections slowing in many countries. However, the goal of developing a safe and effective vaccine has not yet been reached. This is due to factors including the unique nature of the HIV-1 virus and the complex human dimensions of the infection, such as same-sex and mother-to-child transmission, the breadth of cultures involved and hard-to-treat patients. While pre-exposure prophylaxis (PrEP), treatment as prevention and other preventive methodologies have greatly reduced rates of transmission, these approaches also pose ethical and scientific challenges for the design of preventive vaccine studies.
The HIV Pandemic
Since the early 1980s, there have been 35 million deaths due to HIV, with an estimated 78 million people infected1 (Figure 1 on the following page). Some 37 million people are currently living with HIV, of whom 30-40% are unaware that they are infected. There are 2.1 million new HIV infections each year.