How Biomarker Research Has Brought Scientists Closer to an HIV Vaccine

An Overview of the Publication

Wallace told PharmaNewsIntelligence that the AMP study “was a proof-of-concept study that sought to test and evaluate whether the broadly neutralizing antibody researchers were using would be effective at preventing HIV.”

As it is common knowledge that all bodies develop antibodies to introduced diseases or infections,  Wallace briefly explained broadly neutralizing antibodies as opposed to regular antibodies.

“Because there's so much genetic diversity in HIV, regular antibodies wouldn't be as efficient to respond to HIV in the body. Broadly neutralizing antibodies would be important and broadly means that they can address HIV in its different strains or iterations.”

The main product of this study is the discovery of a biomarker that may be used later to develop a vaccine or other HIV prevention tools.

“The biomarker that's being described is PT80. This particular biomarker is novel and important to acknowledge because the prior surrogate biomarker that scientists were using, IC80, could not tell us whether there were sufficient antibodies in the body or quantify the number of antibodies in the body and couldn’t tell researchers the antibody's killing power.”

“PT80 can do those things, at least based on the results from this analysis. The goal is to continue to validate it as a true endpoint going forward,” he expanded.

A Global Initiative

The studies analyzed in the paper use data collected globally. Wallace said, “there was a trial cohort also occurring in Southern Africa. The trials have clinics, not just here in the US but in Latin America, Mexico, Brazil, Argentina, and Peru, several countries in Southern Africa, and a few countries in Europe. This must be a global response and not just a US response.”

A global understanding of HIV and HIV care is essential to the progression of disease treatment. Collaborative research can provide additional insights on how to develop a vaccine properly. Beyond vaccine development and collaboration, having a larger patient population and data set can ensure accurate and broadly applicable research.

Stigma and Mistrust

In addition to discussing the benefits of this research for the HIV community. Wallace also talked to PharmaNewsIntelligence about the stigma surrounding HIV. Wallace explains how he and his colleagues are working to reduce the stigma surrounding HIV and foster trust between researchers and the communities this research is meant to serve.

Recent PrEP Ruling

In light of the recent ruling in which a Texas Judge voted against mandating PrEP coverage, the stigma around HIV may be further propagated.

When asked how this ruling may impact research, Wallace told PharmaNewsIntelligence that “the real impacts will be seen in communities and among people who desire PrEP, and those who may be wondering whether PrEP is the right option for them. This ruling could impact the stigma that exists around HIV as well."

Clearly, there is already a stigma around HIV in the US and worldwide. Wallace implies that this ruling could further enhance that stigma and discrimination can appear in numerous different ways, such as stigmatizing people seeking PrEP and other HIV prevention mechanisms.

“It may impact people's decision about whether or not to even engage in PrEP or with the PrEP regimen overall. So, there are many considerations for the individual and the community,” noted Wallace.

Combatting Distrust from Marginalized Communities

In addition to explaining the stigma around HIV and its impact, Wallace also shared his thoughts on the mistrust between marginalized communities and the research community. Historically, marginalized communities have been mistreated when it comes to medical research. Not only have their contributions been sidelined, but treatments are frequently not catered to these populations.

Because of this mistreatment, there can be a level of uncertainty between these communities and researchers, as seen throughout the COVID-19 pandemic. Wallace’s team hopes to garner the trust of marginalized communities by including them in HIV prevention and care development and advancement.

“The message matters. How the message is constructed will be focused on these communities and who the messenger is. Having messengers from the community share this information with other community members would be really important. One of the best ways to do that is to ensure that those communities are involved in the research process. So, if communities are engaged and involved, there's a higher likelihood of acceptance and uptake down the road for eventual products,” Wallace highlighted.

Furthermore, researchers must develop ways to deploy these interventions and reach these marginalized groups effectively.

“Marginalized communities have different intersecting identities that result in layered oppression, for example, Black transgender women. It is really important to partner with social groups that engage these communities more actively and go where they are. It is important to go to these communities, set up mobile clinics in community spaces, and attend community events where LGBTQ people associate and congregate to make the vaccine more accessible,” suggested Wallace.

Future Research Directions

While this study was not directly focused on developing a vaccine, the outcomes of the publication and AMP may work to help develop future vaccines. Wallace told PharmaNewsIntelligence that “the downstream effect of this research has the potential to help us identify an antibody cocktail that might be an effective tool in the arsenal of tools to prevent HIV.”

He continued by saying, “right now, we have condoms and PrEP treatment as prevention, and quite a few other tools, behavior change, education, and HIV testing are other examples. Having additional tools in the proverbial toolkit would be helpful for many communities who desire choice, options, and thinking about the best strategies for them. The cocktail also allows us to identify a real pathway to developing an HIV vaccine.”

As the research continues and investigators like Wallace contribute discoveries, members of the HIV community will monitor the changes. Clinicians and researchers are urged to collaborate on HIV and HIV treatment research to produce effective treatments further.