19 Jul 2022
Johannesburg/New York City/Oslo. 19 July 2022: Aurum Institute, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Human Vaccines Project are partnering to deliver an important African-initiated COVID-19 vaccine strategies study. CEPI will provide up to $10.4 million in funding to support a clinical trial to assess the safety and immunogenicity of mixed vaccine strategies of three COVID-19 vaccines in people living with or without HIV in South Africa, where the HIV burden is high.
People living with HIV are more likely to progress to more severe COVID-19 disease due to their compromised immune systems. In addition to potentially increased susceptibility to infection, morbidity and mortality pre-vaccination, HIV-infected people may have reduced vaccine immune responses allowing post-vaccination breakthrough infections to occur. However, data on the effectiveness of COVID-19 vaccines in people living with HIV remain limited so it is important to gather additional data about the safety of the vaccines and their ability to induce protective immunity in HIV-infected individuals to inform the development of vaccination strategies in regions with high prevalence of HIV.
The overarching goal of this trial is to investigate the safety and immunogenicity of mixed COVID-19 vaccine strategies in HIV-infected and HIV-uninfected individuals. It will be conducted at up to five established Aurum Institute clinical research sites in South Africa. The first participant was enrolled in the trial on 12 July 2022.
The study will evaluate three different authorized vaccines either as a single dose in unvaccinated HIV-infected individuals with documented prior SARS-CoV-2 infection, or as boosters in persons with or without HIV who have previously been vaccinated. Janssen’s adenovirus vectored vaccine (Jcovden), Pfizer’s mRNA vaccine (Comirnaty), and Serum Institute of India/ Novavax’s protein-based vaccine (Covovax) will all be included in the study. Each of these vaccines features in the rollout of vaccines in Africa, including through COVAX.
In line with CEPI’s Equitable Access Policy, the data generated by this trial will be shared through open-access publications and via scientific meetings to ensure that all can benefit from the research. The data will help to inform the recommendations of policy makers and regulatory authorities on the use of COVID-19 vaccines in HIV-infected and HIV-uninfected populations.
Co-Principal Investigator and CEO of Aurum Group
CEO of the Human Vaccines Project and International Principal Investigator
Executive Director of Vaccine Research and Development, CEPI
The study consortium brings together the Aurum Institute’s extensive clinical trials experience in conducting vaccine trials with the Human Vaccines Project’s leading human immunology-based clinical research consortium, focused on advancing vaccine development by deciphering the principles of effective immunity in populations most vulnerable to disease. Statistical support is provided by the South African Medical Research Council’s (SAMRC) Biostatistics Unit, whose expertise supports the organization’s network of researchers as well as government departments and national and international research bodies. Study vaccines are sponsored by Janssen Pharmaceuticals, Serum Institute of India and the South African National Department of Health.
This project will also be supported by partner laboratories: the South Africa National Institute of Communicable Diseases (NICD), Cytespace Laboratories, Medical Microbiology Laboratory, University of Kwazulu-Natal, the Viral Immunology Laboratory (VIL), University of Cape Town (UCT) and HVP Partner Laboratories.
This is the latest programme to be funded in response to a CEPI Call for Proposals which aims to address gaps in our clinical knowledge of vaccine performance both now and in the long term, in order to expand access to COVID-19 vaccines as part of the global vaccination rollout. Examples of such gaps include assessment of the safety and effectiveness of COVID-19 vaccines in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, mix-and-match strategies, and dosing intervals.
This work forms part of CEPI’s 5-year plan, published in March 2021, which aims to reduce or even eliminate the future risk of pandemics and epidemics. As part of this plan CEPI is working to strengthen our defences against COVID-19 and reduce the risk of future coronavirus pandemics, by optimizing our current vaccines, addressing variants of concern, developing next-generation COVID-19 vaccines, and initiating the development of broadly protective or universal coronavirus vaccines.
In response to CEPI’s Call for Proposals to generate additional clinical data on COVID-19 vaccines, CEPI is also funding a study of COVID-19 vaccines in immunosuppressed and transplant patients, a project to expand access to BBIBP-CorV in Africa, clinical trials of mix-and-match combinations of vaccines in Pakistan and Taipei, and a study to assess mix-and-match boosters in people living with HIV in DRC, Kenya and Rwanda. In addition, CEPI has previously announced funding to support a mix-and-match study led by the University of Oxford, and is supporting trials to evaluate fractional COVID-19 booster shots in multiple countries.
A summary of these CEPI-funded projects can be found here.
About Aurum Institute
Established in 1998, the Aurum Institute is an African Public Benefit Organization whose mission is to generate evidence for policy and translate policy into practice to positively impact the health of communities globally. Aurum’s headquarters are in South Africa with offices in Ghana, Mozambique, the U.S.A and Europe. www.auruminstitute.org
About Human Vaccines Project
The Human Vaccines Project is a nonprofit public-private partnership with a mission to decode the human immune system and accelerate the development of vaccines and immunotherapies across major global diseases. The Project brings together leading academic research centers, industrial partners, nonprofits and governments to answer core questions about how the human immune system fights disease and pioneer a new era in human health. www.humanvaccinesproject.org
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at https://endpandemics.cepi.net.
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