- Trail aims to evaluate safety, tolerability, and immunogenicity of vaccine candidate
- First dose given today, in Lusaka, Zambia
- Vaccine aims to combat numerous HIV strains, a key requirement of any vaccine to end the HIV/AIDS epidemic
3 August 2021: The Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership (GREAT) announced today start of vaccinations in a Phase I clinical trial of a novel HIV vaccine candidate. With the first dose given at the Center for Family Health Research in Zambia (CFHRZ), in Lusaka, Zambia, the trial will extend to sites in Kenya and Uganda in the coming weeks.
“International partnerships are crucial in developing and evaluating HIV vaccine candidates in countries and communities where HIV vaccines will ultimately have the greatest public health impact,” said Dr. William Kilembe, project director of CFHRZ and trial principal investigator. “CFHRZ is proud to be part of the consortium evaluating HIVconsvX and to deliver the first dose of this experimental HIV vaccine in the HIV-CORE 006 trial.”
The goal of the trial, known as HIV-CORE 006, is to evaluate the safety, tolerability, and immunogenicity of a novel vaccine candidate, HIVconsvX, a mosaic vaccine targeting a broad range of HIV-1 variants, making it potentially applicable for HIV strains in any geographical region.
Tomas Hanke, professor of vaccine immunology at the University of Oxford, and lead researcher on the trial, said: “This highly rational, bioinformatics-assisted, vaccine design addresses the enormous variability of HIV-1 – one of the greatest challenges to the development of an effective vaccine against HIV/AIDS.”
Dr. Paola Cicconi, senior clinical research fellow at the University of Oxford, and the trial chief investigator, said: “An effective HIV vaccine remains an essential but unrealised component of the HIV prevention toolkit and remains the most cost-effective and desirable solution to end the HIV epidemic.”
The trial will see 88 healthy, HIV-negative adults, aged 18-55, who are considered not to be at high risk of infection, receive one dose of the vaccine initially, followed by a further booster dose at four weeks.
While most HIV vaccine candidates work by inducing antibodies generated by B-cells, HIVconsvX induces the immune system’s potent, pathogen obliterating T cells, targeting them to highly conserved and therefore vulnerable regions of HIV – an “Achilles heel” common to most HIV variants.
“It is crucial that we have a diverse pipeline of HIV vaccine candidates that target both the antibody and T-cell arms of the immune system,” said Dr. Vincent Muturi-Kioi, medical director at IAVI. “HIVconsvX represents an exciting new hypothesis in engaging the killer T-cell arm to prevent HIV infection.”
At present, prevention of HIV largely focuses on behavioral and biomedical interventions such as voluntary medical male circumcision, condom use, and anti-retroviral drugs used prior to exposure.
“Preventive vaccines, especially those that provide durable protection against all major HIV subtypes, would be a powerful tool for people not able to access or use existing prevention options,” said Dr. Walter Jaoko, director of KAVI-Institute of Clinical Research (KAVI-ICR) and trial principal investigator. “This is why it remains a priority that we design and evaluate novel vaccine approaches such as HIVconsvX.”
The researchers hope to be able to report results of the HIV-CORE 006 trial at the end of 2022.
Notes to Editors
About the research team
Led by Professor Tomáš Hanke at the Jenner Institute at Oxford University. In addition to Hanke, the trial’s Chief Investigator is Dr. Paola Cicconi at the Jenner Institute at Oxford University and other principal investigators are Pontiano Kaleebu, M.D., Ph.D. director of MRC/UVRI and LSHTM Uganda Research Unit; Walter Jaoko, M.D., Ph.D., director of KAVI-Institute of Clinical Research (KAVI-ICR); Eduard Sanders, M.D., Ph.D., principal investigator at KEMRI-Wellcome Trust Research Programme; and William Kilembe, M.D., M.Sc., project director of the Center for Family Health Research Zambia (CFHRZ).
To request an interview with any of the researchers, please contact their institution directly.
About the HIV-CORE 006 Trial
The Phase I clinical trial will enroll 88 adults, ages 18-50, who are HIV negative and who are not at high risk of infection. Participants will be randomised to receive either the vaccine regimen or placebo. Participants in the vaccine arm will receive one dose of the ChAdOx1.tHIVconsv1 prime at enrolment followed by one dose each of the MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at four weeks after enrolment. The vaccine candidates are administered through intramuscular injection and follow-up will occur for 48 weeks.
The HIV-CORE 006 trial is supported by the European and Developing Countries Clinical Trials Partnership (EDCTP), with co-funding from IAVI and Oxford University, and builds on extensive research expertise and infrastructure, as well as successful community engagement programs, at KAVI, KWTRP, UVRI and CFHRZ. Contract manufacturing organizations Advent (Pomezia, Italy) and IDT Biologika (Rosslau-Dessau, Germany) manufactured the vaccine candidate used in the trial. In parallel, GREAT is strengthening local capacity through support for a range of projects at IAVI-partner clinical research centers to prepare them for participation in future large-scale vaccine efficacy trials.
This project is part of the EDCTP2 programme supported by the European Union (grant number SRIA2015-1066). The vaccines were manufactured through funds from EDCTP, IAVI and the European AIDS Vaccine Initiative 2020 (EAVI2020).
IAVI’s contributions to GREAT are made possible by the support of the American People through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID). The contents of this study are the sole responsibility of the trial sponsor and partners and do not necessarily reflect the views of PEPFAR, USAID, or the United States Government. The full list of IAVI donors is available here.
About the HIVconsvX vaccine candidate
The HIVconsvX immunogen (insert) has been designed by Professor Hanke together with Dr. Bette Korber of the Los Alamos National Laboratory. It is an upgraded version of HIVconsv, which demonstrated in several prime-boost studies with a simian adenovirus prime and poxvirus MVA boost that the most vulnerable parts of HIV neglected by the immune system during natural infection can induce robust immune responses.
About the GREAT consortium GREAT is a collaboration with Oxford University, IAVI, Imperial College London, KAVI-Institute of Clinical Research (KAVI-ICR) at the University of Nairobi, the Uganda Virus Research Institute-IAVI HIV Vaccine Program (UVRI-IAVI), the MRC/UVRI and LSHTM Uganda Research Unit, the Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), and CFHRZ.