HVTN 705/HPX2008 – The Imbokodo Study


By: Dr. Philipp Mann and Carrie Sopher- HVTN, Seattle, WA, USA with contributions from the HVTN 705/HPX2008 Protocol Team

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HVTN 705/HPX2008 is an HIV vaccine efficacy trial, designed as a proof of concept for a combination vaccine regimen. It completed enrollment on May 28, 2019, and now continues in follow-up.

The study aims to show the level of efficacy that can be provided by a combination of two different HIV vaccine candidates. An Adenovirus Vector Vaccine, Ad26.Mos4.HIV, is given at two timepoints, followed by two administrations of a combination of Ad26.Mos4.HIV and a protein vaccine called Clade C gp140. The study will enroll 2600 young women at 24 sites in 5 sub-Saharan countries: Malawi, Mozambique, the Republic of South Africa, Zambia, and Zimbabwe. 1300 will receive the combination vaccine regimen, and 1300 will receive placebo. The women enrolled in this study will be healthy, HIV uninfected volunteers at risk of HIV infection.

Several studies have evaluated the different components of this regimen, and pre-specified “Go/No-Go criteria” were met before the study was started. The results are expected to inform the HIV vaccine field and the HIV prevention field at large.

Table 1. Study schema
Table 1. Study schema

The HVTN 705/HPX2008 study represents an ongoing collaboration between the HIV Vaccine Trials Network (HVTN) and multiple partner organizations. The study is sponsored by Janssen Vaccines and Prevention B.V., part of the Janssen pharmaceutical companies of Johnson & Johnson, with co-funding from two primary partners, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Bill & Melinda Gates Foundation. Other partners providing support include the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, US Army Medical Materiel Development Activity (USAMMDA), and the Ragon Institute. The development of this study was an extensive, multi-stakeholder effort. The partners are all motivated by the continued impact of the HIV epidemic despite recent advances in HIV prevention and treatment. We are inspired by the potential contribution an effective HIV vaccine could have on the devastating pandemic.

The first participant enrolled in this study on 9th November 2017, with participants enrolled at 21 active research sites. Enrolling such a large number of participants requires tremendous work within the communities and as such, community engagement efforts began months before the trial opened, underscoring the HVTN’s commitment to community engagement. These early efforts included trainings and stakeholder engagement meetings, as well as additional local and regional activities designed to engage communities early on in the trial development and implementation phases to ensure community support, and a degree of ownership, of the study. Community engagement activities have remained strong throughout the ongoing conduct of the study. HVTN staff meet with the sites’ community engagement teams regularly to provide support that is focused on working in the communities, concentrating on community education and effective recruitment and retention strategies.

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A team of dedicated laboratory, statistical, data management, core operations, and clinical staff based in the participating countries, the US, the Netherlands, Belgium, and beyond are supporting committed community educators, recruiters, CAB members, clinicians, data managers, laboratory technicians, investigators, clinic coordinators, and many others at our fantastic study sites. Together with our inspiring study participants, the HVTN 705/HPX2008 team hopes to find an effective HIV vaccine, moving us all toward an AIDS-free future. 

 

 

 

 

 

Dr. Philipp Mann is the HVTN Protocol Team Leader and Carrie Sopher is the HVTN Clinical Trial Manager for HVTN 705/HPX2008.