Johnson & Johnson unit Janssen Pharmaceutical Companies has reported positive early stage data from the APPROACH study, a Phase l/lla clinical trial of an investigational HIV-1 vaccine for the treatment of human immunodeficiency virus (HIV).
The trial enrolled 393 healthy adult subjects in the US, Rwanda, Uganda, South Africa and Thailand to examine the safety, tolerability and immunogenicity of several mosaic-based, prime-boost vaccine regimens for HIV-1.
These vaccine regimens include two main doses of the mosaic viral vector Ad26.Mos.HIV, followed by two doses of either Ad26.Mos.HIV, MVA-Mosaic and/or different doses of the soluble protein Clade C gp140 adjuvanted with aluminium phosphate.
At 52 weeks into the trial, four weeks after the last vaccine dose, all vaccine regimens were found to be safe and generally well-tolerated.
The regimens also demonstrated significant humoral and cellular HIV-1 immune responses.
In addition, the trial found the mosaic Ad26 and Ad26+gp140 regimen as the most immunogenic regimen in combating HIV in humans.
The regimen elicited Env-specific binding antibody responses, antibody-dependent cellular phagocytosis responses, and T-cell responses in 100%, 80% and 83% of the trial’s subjects, respectively.
The US National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program, Beth Israel Deaconess Medical Center and International AIDS Vaccine Initiative and others are involved in the APPROACH study.
Beth Israel Deaconess Medical Center Center for Virology and Vaccine Research director Dan Barouch said: “These are promising but still early stage results.
“At 52 weeks, we observed that the mosaic HIV vaccine induced robust and comparable immune responses to HIV in humans and in non-human primates, and the vaccine protected against infection with an HIV-like virus in non-human primates.”
Based on the new APPROACH study results, a Phase llb trial has been started to evaluate the efficacy of Ad26/Env HIV-1 vaccine to determine its ability to prevent HIV infection in humans in southern Africa.
Results from the trial are expected to be released by 2021.