Moderna Begins mRNA HIV Vaccine Clinical Trial

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Moderna and the International AIDS Vaccine Initiative (IAVI) have started the clinical trial of an experimental HIV vaccine that uses the same mRNA technology used in some COVID-19 vaccines. Romy Arroyo Fernandez/NurPhoto via Getty Images
  • Moderna has given volunteers the first doses of its mRNA-based HIV vaccine in a clinical trial.
  • The vaccine delivers instructions to HIV-specific antigens that could potentially elicit certain immune responses.
  • It has taken decades to develop an HIV vaccine, and mRNA technology can help speed the process.

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 court hearing is conducted in partnership with the non-profit International AIDS Vaccine Initiative (IAVI). Researchers are testing whether an mRNA-based vaccine that provides the instructions for HIV-specific antigens can induce specific immune responses.

These antigens, also known as immunogens, were developed by scientific teams at IAVI and Scripps Research. ONE „Proof-of-Concept“-Studie Last year found that one of these immunogens elicited the desired immune response — by activating the right types of B cells — in 97 percent of participants.

This experiment delivered the priming immunogen itself to the cells. The current study will use Moderna’s mRNA technology to deliver the genetic instructions for the immunogen, which the cells will then use to make that protein.

In addition, the researchers are testing a separate boosting immunogen – also delivered via the mRNA platform – to see if it can help B cells continue to mature in the right direction.

“We are very excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” said Dr. Mark Feinberg, President and CEO of IAVI, in a Explanation.

“The quest for an HIV vaccine has been long and challenging, and new tools in the form of immunogens and platforms may hold the key to rapid progress toward a much-needed, effective HIV vaccine.”

The new study, funded in part by the Bill & Melinda Gates-Stiftung, is the first step in the process of controlling the maturation of certain types of B cells.

The ultimate goal is to stimulate the development of B cells that can produce broadly neutralizing antibodies that can target a wide range of HIV variants.

A potential 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 study. Of these, 48 will receive 1 or 2 doses of the immunogen-priming vaccine while 32 will also receive the immunogen-boosting vaccine. Eight people will receive the boosting immunogen vaccine only.

In addition, researchers will follow participants for 6 months after their last dose to assess their immune responses and monitor for potential safety concerns.

It has been almost 40 years since scientists identified the human immunodeficiency virus (HIV) as the cause of AIDS.

Since then, researchers have tried to develop an effective vaccine to protect against HIV – with several large-scale phase 3 clinical trials, but without real success.

A challenge in developing an HIV vaccine is that once the virus has infected a cell, it replicates wildly, so an effective vaccine would essentially have to block all infections.

“When [HIV] comes through to cause an infection, even if someone has been vaccinated, then that infection is lifelong,” he said Dr. Davey Smith, Infectious Disease Specialist and Translational Research Virologist at the University of California, San Diego.

The COVID-19 vaccines also do not offer such complete protection against infection. However, they still offer strong protection against serious illness, hospitalization and death.

The bar for an HIV vaccine is raised because of the need to prevent lifelong infection with the virus.

There is effective HIV drugs which can reduce the replication of the virus in the body, but they do not eliminate the virus completely. These medicines can help people live long and healthy lives and reduce the risk of passing the virus on to others.

Previous attempts at HIV vaccines have focused on getting the immune system to produce neutralizing antibodies that inactivate the virus, for example by preventing it from infecting cells.

But HIV is rapidly evolving to create new variants, even more so than the influenza virus.

Every year the seasonal flu vaccines need to be updated to reflect the virus strains expected to spread through the community.

In comparison, one to learn estimates that the global diversity of influenza virus genetic sequences is comparable to the diversity of HIV sequences found in a single person with the virus.

The wide genetic variation of HIV makes it difficult to combat the virus with a vaccine because neutralizing antibodies produced in response to a vaccine may only be effective against a few strains of HIV.

Recent HIV vaccine research has focused on developing vaccines that can generate broadly neutralizing antibodies that target parts of the virus surface common to many strains.

The scientists at IAVI and Scripps are pursuing this approach. The challenge is finding the best immunogens to direct the maturation of B cells to produce these broadly neutralizing antibodies.

Moderna’s mRNA technology can help speed up this process, as much of the work involved in designing the vaccine can be done on a computer.

This ability helped researchers develop candidate COVID-19 vaccines within days after Chinese scientists published the genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19.

“We have a promising proof of concept for germline targeting in [last year’s trial], and this study allows us to take that approach to the next phase,” William Schief, PhD, a professor at Scripps Research, said in the statement.

“Additionally, Moderna’s technology has allowed us to accelerate the production of clinical trial material at a remarkably fast pace,” he said.

Smith cautions against overdoing the current study, particularly given HIV’s ability to evade the body’s immune responses, even those stimulated by vaccines.

“It’s a very, very high hill for this new mRNA technology to climb,” he said, “to generate a very broad and strong immune response to protect against HIV.”

Still, he believes there is much to be gained from this research.

“I think they set up these experiments very wisely to learn as much as possible,” he said. “What is the immunogen that really kickstarts the immune system? And what will help us protect people from future exposure to HIV?”

He is also grateful for the renewed interest in finding a vaccine for HIV.

While the World Health Organization (WHO) has given HIV “epidemic” status, many argue against it should be called a “pandemic”. because of the millions of people living with HIV worldwide.

“We should not give up on the last pandemic [HIV] just because we’re fighting the COVID-19 pandemic,” Smith said. “So I really applaud investigators for looking at new technology to develop an HIV vaccine, one that even after nearly 40 years of trying, we still haven’t gotten.”

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