Immunogenicity Data Patterns Emerging from Cross Trial Comparisons

Tracey Day, Barbara Metch, Nicole Frahm, and Cecilia Morgan

A major advantage for vaccine studies conducted by the HIV Vaccine Trials Network (HVTN) is the uniformity with which the trials are conducted and evaluated. This includes maintaining similar key study design elements, as well as standardized methods for operational procedures, clinic procedures, data capture, and immunogenicity assessments. This consistency facilitates efficient trial implementation and ensures robust immunogenicity results.¹ It also provides the ability to compare immunogenicity data across multiple trials.

Orlando HVTN 505 Study Site: From Challenges to Accomplishments

Edwin DeJesus and Keith Barsky

Orlando site recruiting event. From right to left: Keith Barsky, Dino Martino, Tomas Devia, Anthony Egreja, Juan Rodriguez, Saul Leon

In October 2010, the Orlando Immunology Center (OIC) became an expansion site for the HIV Vaccine Trials Network (HVTN). Although new to the HVTN and the NIH’s Division of AIDS (DAIDS), we had over 20 years of experience in recruiting patients into privately-sponsored clinical trials for various pharmaceutical companies and NIH-sponsored programs. However, we were faced with the reality that many of the established HVTN programs, services, and strategies had not yet been tested or implemented at an independent private site. Some of those elements required modifications to meet the needs of our clinic and our community.

Turning Up the Heat in Miami

Jim Maynard

Vic Sorrell’s karaoke recruitment event inspired other recruiters at the Miami Recruiters’ Retreat

Vic Sorrell sings like an angel and he’s found a way to make it work for him in Nashville. Vic had a great idea to create excitement and draw attention to HVTN 505. He did it with song! Vic launched a city-wide Karaoke competition that used other people’s love of singing to raise money for a local AIDS service agency, while educating his community about the trial and collecting contacts from dozens of interested volunteers. He took a fresh idea and turned up the heat on recruitment in Nashville and now it was time to spread that fire in Miami and beyond!

Recruitment staff from across the United States joined HVTN’s Core Community Engagement (CE) Project Managers in Miami in January to share their very best ideas and brainstorm new ones, all for the sake of increasing enrollment in HVTN 505. This trial, the only HIV vaccine efficacy trial in the world, has been very difficult to enroll.

Probing the Diversity of Vaccine Elicited HIV-1 Antibodies: Informed by the RV144 Correlates Analysis

Georgia D. Tomaras

RV144, a trial conducted by the U.S. Military HIV Research Program and the Thai Ministry of Health, was the first HIV-1 vaccine study in which a modest efficacy (31.2%) of HIV‑1 vaccination was shown. The study regimen consisted of a canarypox prime expressing Gag, Pro, and gp120 (ALVAC-HIV), and a gp120 boost (AIDSVAX® B/E). These results were published in the New England Journal of Medicine in 2009.¹

A concerted effort by an international consortium of investigators, led by Dr. Barton F. Haynes of Duke University, set out to determine if any immune variables correlated with infection risk in the RV144 trial. In the initial phase of the studies, there was an open call to measure vaccine-elicited immune responses on RV144 samples. In the next phase, a selected set of immune variables, chosen from the pilot study results, were formally tested as primary immune variables for the correlates analysis of RV144.

Assays to Probe the Humoral Response

Georgia D. Tomaras

There are several categories of assays used to examine the diverse humoral response to vaccination: 1) validated assays for HIV-1 vaccine endpoints, 2) qualified and/or standardized assays and 3) assays for research and development. Validated assays are currently used in the first line assessment of HIV-1 vaccine trials. Qualified and/or standardized assays are utilized to generate hypotheses and further characterize vaccine immunogenicity. Assays for research and development are more exploratory in nature and are not suitable as a vaccine study endpoint, but can provide substantial insight into the complexity and potential functionality of vaccine elicited immune responses.

Assessing Mucosal Immune Responses in HIV Vaccine Trials

Tracey Day and Florian Hladik

HIV infection most frequently occurs via sexual transmission of the virus through the mucosal surfaces of the genitals or rectum. The gut mucosa also serves as a site where the virus inflicts significant damage on the immune system during the first few weeks of infection. A primary focus of HIV preventive vaccine research is therefore the induction of protective immune responses in these crucial early battlefields.

PDF Version of New Issue Available

The PDF version of the new HVTNews issue (July 2012) is now available at http://hvtn.org/science/hvtnews/hvtnews-Jul2012Web.pdf. The blogged stories will appear shortly. We apologize for the delay.