Moderna Starts HIV Vaccine Research

Opening New Doors
Moderna to Begin HIV Vaccine Research Using COVID-19 Technology
by Chip Alfred

Based on the success of its COVID-19 vaccine, Moderna, a biotech company pioneering messenger RNA (mRNA) therapeutics and vaccines, is expanding its pipeline of innovative vaccines to include two new clinical trials testing vaccine candidates against HIV.

“The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna,” said Stéphane Bancel, Moderna’s chief executive officer. “Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more ambitious development programs within our prophylactic vaccines modality. We are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology.”

In an interview published on previewing the 4th HIV Research for Prevention Conference, Dr. Anthony Fauci explains why an HIV vaccine has been so challenging for researchers to find. “A vaccine generally mimics the body’s natural immune reaction to a virus that usually results in being cleared,” he said. “This is why I knew—not hoped—that we could develop a COVID vaccine, because in 98% of cases the immune system does clear the virus sooner or later. But in HIV, it doesn’t. So, a vaccine has to elicit an immune response that’s better than nature, and that’s hard to do.” He added that HIV vaccine research had “absolutely” enabled the development of the COVID vaccines. “What goes around comes around, and I expect this to feed back into HIV vaccine development.”

From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment, and prevention of HIV. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is a novel approach to HIV vaccine strategy in humans designed to elicit broadly neutralizing HIV-1 antibodies.

A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. The company expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 this year.

Photo by iStock

More About mRNA Vaccines
mRNA vaccines are some of the first COVID-19 vaccines authorized for use in the United States. They are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. This is not the case with mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

Researchers have been studying and working with mRNA vaccines for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines.

A&U asked Luis Montaner, DVM, DPhil, Herbert Kean, MD, Family Endowed Professor and Leader of the HIV-1 Immunopathogenesis Laboratory and Leader of the HIV Research Program, Vaccine & Immunotherapy Center at The Wistar Institute in Philadelphia for his take on Moderna’s announcement.

“Before COVID, there was a lot of apprehension to diverge from the incremental steps of vaccine development. COVID changed the rate of vaccine development by delivering a vaccine in less than a year. In addition to speed, there was greater acceptance to clinically test novel strategies that had been stalling to break through. With COVID, there was a rush of innovation like Moderna’s mRNA COVID vaccine able to be tested clinically.”

He adds that with an mRNA COVID vaccine now having established proof-of-principle, “it has opened different possibilities for vaccine design in other applications such as HIV.”

Dr. Montaner believes that people already living with HIV could also see benefits from mRNA technology. “I think there are developing strategies that could develop for efficacious vaccines or prevention that are going to spill over into controlled cure or alternative therapies for persons living with HIV. We’re seeing that already with broadly neutralizing antibodies that are being promoted and tested as an alternative for HIV antiretroviral therapy.”

He also points out there are the bigger issues of stigma and criminalization, which would hopefully diminish if a vaccine is generated. “The whole narrative around HIV is going to change. Both HIV-positive and HIV-negative people have something to gain here.”

Chip Alfred is A&U’s Editor at Large, a public speaker, and a media and public relations consultant based in Philadelphia. Follow Chip on Twitter @ChipAlfred.