This is the first of a series of reflections from AVAC staff and members of the Vaccine Advocacy Resource Group (VARG) on the regional meeting of the HIV Vaccine Trials Network (HVTN), which took place in Johannesburg from Feb. 28 to Mar. 1, 2017.
AMP. Licensure. Enrollment targets. Success.
These were a few of the buzz words from the HIV Vaccine Trials Network (HVTN) regional meeting last month. This meeting, the first of three the network will convene in 2017, was held in Johannesburg, highlighting the HVTN's build out of programs in sub-Saharan Africa -- and the significance of an HIV vaccine for this region.
As network meetings go, the audience for this meeting was largely internal; a chance for HVTN core staff and leadership to celebrate key milestones, particularly around the network's two large efficacy studies -- HVTN 702 and the Antibody Mediated Prevention Trials (AMP) -- with their clinical site partners.
While advocates are not the primary audience, the HVTN allows us to attend plenaries and other open sessions. AVAC and civil society partners look to these meetings to hear updates, interact with research teams, and continue to build our research literacy and our translation and liaison roles in the HIV vaccine field.
To advocates -- both from AVAC and the Vaccine Advocacy Resource Group (VARG), a global team of HIV prevention advocates -- looking in from the outside, this meeting underscored the intensity of resources necessary to make clinical trials happen and allowed us to get a sense of how the vaccine field sees itself.
What follows are impressions from AVAC and a few VARG members from our times in meeting rooms -- and in hallways.
The AMP trials are in an exciting place -- exceeding enrollment targets across all sites, both in the Americas and Southern Africa, and maintaining high retention and adherence. While we are thrilled about the trials' current success, and intrigued by passive immunization as a potential prevention strategy, we felt a gap in communication from the trial's architects about how to situate it in the broader field. AMP is testing a 30-60 minute infusion of an antibody called VRC01 that is administered every two months for just under two years. While there was much discussion about this particular antibody and others in development, it's not yet clear how researchers will build on the AMP results to deliver a feasible prevention option. We were left with questions about what will happen with VRC01 if the trial shows efficacy, as its dosing schedule makes it hard to imagine as a real world tool. There are also more powerful antibodies and easier methods of administering them that are being explored. We want to be sure that the goals and follow up steps of AMP are well articulated and understood. Watch this space -- it is sure to evolve quickly!
The first vaccine efficacy trial in seven years is now in its 22nd week of enrollment. As 702 sites continue to get started and data from the precursor trials, RV 144 and HVTN 100, continue to provide more clarity on mechanisms of improving immunogenicity, we note a need for cautious optimism. While 702 presents a possibility for moving toward a licensed vaccine, we were a bit concerned about the hopes being raised about this trial, and feel strongly that the messages should convey realistic expectations. Licensure is the ultimate goal, but we have to closely watch, and accurately translate, the data for ourselves and to our communities. If we've learned one thing from HIV vaccine research, it's that we never know what to expect!
Finally, let's talk about oral PrEP -- researchers certainly did at this meeting. Access to PrEP is (slowly) becoming a reality in trial communities all over the world -- and the HVTN, and all trialists, are grappling with how to incorporate PrEP into trials, especially as this context evolves at national, community, and individual levels. As research advocates, we know that the trial context rarely reflects the real world. While we commend the AMP and 702 teams for exploring ways to connect trial participants to mechanisms for PrEP access, we see a necessity for a more rigorous and urgent commitment to link national and local PrEP programs to participants who need and want it.
Note: This is a crucial area that advocates are watching, and where they can and need to help research teams. Without taking PrEP into account and ensuring that communities have input, clinical trials run the risk of being viewed as skirting larger community needs as well as ethical and human rights obligations.
Now that the meeting is wrapped, and we've had a couple of weeks to reflect, we're left with the feeling that the field appears too siloed. The conversations around antibodies and vaccine candidates seem to be happening in isolation from larger dynamism in the field and the very communities where trials are taking place. The rich and rapidly iterating prevention research environment needs an HIV vaccine -- and an HIV vaccine needs this exciting environment.