Nearly half a decade after HIV emerged, causing a pandemic that has left more than 40 million people dead and more than 38 million currently living with the infection worldwide, hope is finally on the horizon.
Following the recent failure of three experimental vaccines in development, a trial of a preventive HIV vaccine candidate has begun enrollment in the United States and in South Africa with phase 1 trial evaluating a novel vaccine known as VIR-1388.
The study which will be conducted on adults aged 18 to 55 years in overall good health and without HIV will see participants enrolled concurrently into one of three dose levels of VIR-1388 or placebo (any treatment that has no active properties, such as a sugar pill).
The overall study design includes two study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule.
Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use two forms of contraception and maintain a similar overall safety monitoring schedule as Part A.
There is an optional long-term follow-up study that would lengthen study participation for up to three years post-first dose.
The trials will involve testing the safety and ability to induce an HIV-specific immune response in people with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health, providing scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.
