Moderna Launches Clinical Trial of Its mRNA-based HIV Vaccine

Written by: Dr. Ali Khatau

Posted at: 2022-02-09 08:55:41

The first doses of an experimental HIV vaccine that uses Moderna’s mRNA technology have been given to participants in a phase 1 clinical trial, the company announced last week. The trial is being conducted in partnership with the nonprofit International AIDS Vaccine Initiative (IAVI). Researchers are testing whether an mRNA-based vaccine that delivers the instructions for HIV-specific antigens can induce certain immune responses. These antigens, also known as immunogens, were developed by scientific teams at IAVI and Scripps Research. A “proof-of-concept” trial last year found that one of these immunogens generated the desired immune response — priming the right kinds of B cells — in 97 percent of participants.  “We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Dr. Mark Feinberg, president and CEO of IAVI, said in a statement. “The search for an HIV vaccine has been long and challenging, and having new tools, in terms of immunogens and platforms, could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.” The new trial, funded in part by the Bill & Melinda Gates Foundation, is the first step in the process of guiding the maturation of certain types of B cells. The ultimate goal is stimulating the development of B cells that can produce broadly neutralizing antibodies that can target a broad range of HIV variants. An eventual vaccine using this method will likely involve multiple doses given over weeks to years. Researchers will enroll 56 healthy, HIV-negative adult volunteers in the current clinical trial. Of these, 48 will receive 1 or 2 doses of the priming immunogen vaccine, with 32 also receiving the boosting immunogen vaccine. Eight people will receive only the vaccine for the boosting immunogen. In addition, researchers will follow participants for 6 months after their last dose to examine their immune responses and monitor for potential safety concerns. Since then, researchers have tried to develop an effective vaccine to protect against HIV — with several large-scale phase 3 clinical trials but no real success. One challenge with developing an HIV vaccine is that once the virus infects a cell, it replicates wildly, so an effective vaccine would need to essentially block all infection.

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