Johannesburg/New York City/Oslo. 19 July 2022: The 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.

Study design

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. 

Professor Gavin Churchyard, Co-Principal Investigator and CEO of Aurum Group, said: "People living with HIV are at twice the risk of dying from COVID-19 compared to the general population. We cannot afford to leave anyone behind in COVID-19 vaccine research."

Professor Wayne C. Koff, CEO of the Human Vaccines Project and International Principal Investigator, said: “To end the pandemic as quickly as possible, it is vital to evaluate vaccines in the populations most vulnerable. We’re proud that we have entered the collaboration with Aurum Institute with a shared mission to ensure COVID-19 vaccines are safe and effective for people living with HIV.”

Dr Melanie Saville, Executive Director of Vaccine R&D, CEPI said: ”COVID-19 vaccines have saved many million of lives around the world, but some of the most vulnerable people are being left behind by gaps in the clinical data. This trial will evaluate three vaccines that are playing a significant role in controlling the pandemic in Africa, and help to maximise the impact of vaccination strategies to protect people living with HIV.”

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.

Supporting equitable access to vaccines for vulnerable populations

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.

ENDS

Notes to editors

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 and a full list is 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

 About CEPI

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 http://www.endpandemics.cepi.net.

Follow our news page for the latest updates. Follow us via @CEPIvaccines, @DrRHatchett, and LinkedIn.

Media contacts:

Aurum Institute

Kanya Ndaki, This email address is being protected from spambots. You need JavaScript enabled to view it., +27 83 2986100

Human Vaccines Project

Bernadette Mittermeier, This email address is being protected from spambots. You need JavaScript enabled to view it., +49 162 266 5357

CEPI

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• Fixed-dose combination treatments reduce the pill burden from nine to three pills a week for adults and prevent TB in those at highest risk of developing the disease

• Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe will be the first countries out of a total of 12 to provide the new regimen at a US$15 price thanks to funding from Unitaid, PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Johannesburg (3 February 2021)—A new fixed-dose combination (FDC) of “3HP”, a short-course tuberculosis (TB) preventive treatment (TPT) combining two drugs, rifapentine and isoniazid, is starting to be rolled out in five TB high burden countries in Africa. This will reduce the number of pills that people who need the treatment have to take every week from nine to three. Enough treatments for up to 3 million patients are expected to be made available for eligible countries this year. As the result of an agreement concluded by Unitaid, the Clinton Health Access Initiative (CHAI) and the manufacturer of the FDC, Macleods, the latter has agreed to offer a ceiling price of US$15 (ex-works) for a three-month patient course of weekly rifapentine and isoniazid. Thanks to the IMPAACT4TB project funded by Unitaid and led by the Aurum Institute, five initial countries from a total of 12 targeted by the end of the year, will start providing the FDCs in February and March 2021: Ethiopia, Ghana, Kenya, Mozambique, and Zimbabwe. Other countries are expected to receive supplies with the support of PEPFAR and the Global Fund to Fight HIV, Tuberculosis and Malaria.

The partnership with Macleods will bolster efforts to treat TB infection also known as “latent TB” – currently estimated to affect one-quarter of the world population – by broadening access to shorter and easier to use preventive therapies. As part of a wider access strategy to facilitate the introduction of generic rifapentine-based formulations in low- and middle-income countries (LMICs), it will contribute to move towards the United Nations High-level Meeting (HLM) target to provide TPT to at least 30 million people by 2022. “WHO welcomes the new fixed-dose combination TB preventive treatment that will result in reducing the pill burden for people with TB infection, enabling better adherence and outcomes,” said Dr Tereza Kasaeva, Director of World Health Organization’s (WHO) Global TB Programme. “This collaboration between Unitaid, the Clinton Health Access Initiative and manufacturers has been vital to support the uptake of TB preventive treatment as recommended in WHO guidelines. We now look forward to a surge in action from national programmes supported by donors and partners to scale-up access to TB preventive treatment and reach the UN High-Level Meeting targets.”

People with TB infection, often dubbed latent, have no symptoms, are not contagious and most do not know they are infected. Without treatment, 5% to 10% of these people will develop active TB, the form which makes people sick and can be transmitted from person to person.
The agreement establishing the US$15 price and other access conditions was concluded by Unitaid, the Clinton Health Access Initiative (CHAI) and Macleods. The price will be available to government institutions in 138 LMICs, as well as for the international organizations in charge of the procurement. “The ceiling price agreement negotiated with Macleods is another example of our commitment to ensure that effective, quality-assured and affordable TB preventive therapies are made available in low- and middle-income countries,” said Robert Matiru, Director of the Programme Division at Unitaid. “Beyond this deal, we will continue working hard to ensure a healthy market for all manufacturers that wish to develop and commercialize rifapentine-based products.” The first phase of the access strategy resulted in a price discount offer by Sanofi for rifapentine 150 milligram tablets (Priftin®), announced in 2019, lowering a patient treatment course of Priftin® from US$45 to US$15. “The availability of a shorter, more easily tolerated, and safer regimen for TB prevention that is also affordable is critical for accelerating the fight against TB," said Dr. Angeli Achrekar, Acting U.S. Global AIDS Coordinator. "This also has important implications for the HIV response, as TB remains the leading cause of death for people with HIV around the world.” With both Sanofi and Macleods expected to ramp up their production in 2021, Unitaid expects that there will be global availability of enough 3H to reach more than 3 million patients in eligible countries this year, across both manufacturers.

“2020 was a hard year for TB prevention and treatment, as many services were disrupted by lockdowns,” said Prof. Gavin Churchyard, founder and CEO of the Aurum Institute. “But with the roll-out of this new FDC, alongside the existing formulation provided by Sanofi, I’m feeling a renewed sense of optimism that we can get back on track to meet our ambitious global TB prevention goals. Saving lives is the priority. We lose in the end if COVID-19 mortality goes down, but TB rates go up.” With the FDC, a complete course of treatment for eligible adults is included in one box, addressing many concerns about the pill burden of 3HP and ensuring that TPT can be provided conveniently for individuals at risk for TB. With this more convenient product in hand that is easier to dispense, take and adhere to, the IMPAACT4TB consortium members are now working to accelerate the delivery of 3HP in 12 high TB burden countries in Africa, Asia, and South America. For its part, USAID, the largest bilateral funder of TB efforts globally, has been a leader in partnering with high burden TB countries in the successful implementation of their national TB strategies for over 20 years. Preventive TB treatment is a cornerstone of USAID’s Global Accelerator to End TB, which builds countries’ commitment and capacity to reach the United Nations HLM TB targets by 2022. Having a shorter FDC TPT regimen available at a relatively low price will enable USAID to work with partners and stakeholders to rapidly scale up TPT for all who would benefit from it in high burden countries.
Additional quotes

“The availability of this new fixed-dose combination is good news for everyone, especially patients and their families,” said Ahmed Bedru, KNCV Tuberculosis Foundation country representative, leading 3HP implementation for Ethiopia. “Getting people to adhere to a treatment when they are not sick has always been a challenge. The lower number of pills — three pills versus nine pills for an adult — means the treatment is now easier to take, stick to and complete.” “I’ve started to notice patients taking their medication without difficulties or complaints,” said Dr. Tafadzwa Priscilla Sibanda, Medical Director of the Mpilo Centre and a public health specialist working with the AIDS Healthcare Foundation in Zimbabwe. “It really helps that the 3HP regimen is short. When we explain the doses to patients, they can see the light at the end of the tunnel, and they are encouraged knowing that they will complete the course within 12 weeks.”

“Adherence is always a challenge, especially when people have to take many pills for long periods. But 3HP is changing that. The FDC allows patients to take just three pills once a week for 12 weeks. This will be so much better,” said Dr Pereira Zindoga, a clinician with the Mozambique Ministry of Health’s National TB Program. ## About TB infection In 2019 alone, 10 million people fell ill from TB, which killed close to 1.5 million people, over 95% of whom were living in low- and middle-income countries. About one-quarter of the world’s population is infected with TB bacilli and most of them do not have the disease and are not contagious. If left untreated, TB infection may progress to TB disease, the form of TB that makes people sick and is capable of being transmitted from one person to another. TPT regimens like 3HP lower the risk of progression in people at risk.
About 3HP: Using the FDC, the once-weekly dose over 12 weeks — a complete course of treatment for eligible adults — is contained in one box. This formulation addresses many concerns about the pill burden of 3HP and will ensure that TPT can be provided conveniently for programmes, providers and individuals at risk for TB. 3HP offers many benefits for infected individuals, clinicians and programs compared to the previous standard of care, when patients were required to take a pill daily for six months or more.

About IMPAACT4TB: Unitaid is investing US$59 million in the Aurum Institute’s IMPAACT4TB project, to protect people most vulnerable to developing active TB. IMPAACT4TB is led by the Aurum Institute in consortium with the Clinton Health Access Initiative, KNCV Tuberculosis Foundation and John Hopkins University, in collaboration with the World Health Organization (WHO) and the Global Drug Facility (GDF). The four-year grant will prioritize short-course TB preventive treatment for people living with HIV and children under five, and subsequently all those in close contact with TB patients in 12 high-burden countries. The target groups will receive a quality-assured, affordable, short-course TB preventive treatment known as 3HP, consisting of high-doses of two antibiotics that treat TB (isoniazid and rifapentine given weekly for three months). www.unitaid.org and www.impaact4tb.org
South Africa’s Aurum Institute is spearheading the TB prevention project and is working with the Clinton Health Access Initiative, KNCV Tuberculosis Foundation, and John Hopkins University, in collaboration with the World Health Organization and the Global Drug Facility.

About Aurum: Established in 1998, the Aurum Institute is an African Public Benefit Organization whose mission is to improve the health of people and communities living in poverty through innovation in global health research, systems and delivery. It is rooted in Africa and is dedicated to researching, supporting and implementing innovative, integrated approaches to global health with their headquarters in South Africa with offices in the U.S.A, Ghana and Mozambique. The Aurum Institute has developed itself into a leading player, bridging the worlds of research, policy and implementation for impact. www.auruminstitute.org About Unitaid: Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose and treat diseases more quickly, cheaply and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID Tools Accelerator. Unitaid is hosted by the World Health Organization. www.unitaid.org

About WHO: The Global Tuberculosis Programme of WHO works towards the goal of a world free of TB, with zero deaths, disease and suffering due to the disease. The team’s mission is to lead and guide the global effort to end the TB epidemic through universal access to people-centred prevention and care, multisectoral action and innovation. As part of its core functions, the Global Tuberculosis Programme develops policy options, norms and standards for TB prevention and care and facilitates their implementation.

About PEPFAR: Through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. government has invested over $85 billion in the global HIV/AIDS response, the largest commitment by any nation to address a single disease in history, saving over 20 million lives, preventing millions of HIV infections, and accelerating progress toward controlling the global HIV/AIDS epidemic in more than 50 countries.

About KNCV Tuberculosis Foundation: KNCV Tuberculosis Foundation has been fighting TB since its establishment in 1903. Over these 117 years, the organization has acquired indispensable knowledge and experience in the field of effective TB control, resulting in significant contributions to global evidence generation, policy development and TB program implementation worldwide. KNCV has extensive international technical experience in supporting those countries preparing to introduce new drugs and regimens. www.kncvtbc.org

About the Clinton Health Access Initiative, Inc. (CHAI): CHAI is a global health organization committed to saving lives and reducing the burden of disease in low-and middle-income countries. We work with our partners to strengthen the capabilities of governments and the private sector to create and sustain high-quality health systems that can succeed without our assistance. For more information please visit www.clintonhealthaccess.org

About Treatment Action Group (TAG): TAG is an independent, U.S based activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG is the community engagement lead under the IMPAACT4TB project. www.treatmentactiongroup.org 

About the Global Drug Facility (GDF): GDF is the world’s largest procurer of TB medicines and diagnostics. Since its creation in 2001, GDF has facilitated access to TB medicines and diagnostics in more than 145 countries, making quality-assured treatments available to over 36 million people with TB. In 2020 alone, GDF delivered more than USD300 million worth of TB medicines and diagnostics to 123 countries. GDF has led the introduction of all-oral regimens for drug-resistant-TB, child-friendly medicines for drug-sensitive and drug-resistant TB, and advanced diagnostics Since 2012, GDF has secured price reductions of over 50% for most second-line TB medicines, primarily by reducing risk to suppliers and minimizing their transaction costs. http://www.stoptb.org/gdf/ 

About the Johns Hopkins Center for Tuberculosis Research: The Johns Hopkins Center for TB Research was founded in 1998 to contribute to global tuberculosis control through innovative research and training. Its research efforts span the fields of epidemiology, clinical trials, diagnostics and basic science, with faculty from six departments in the Johns Hopkins University Schools of Medicine, Public Health and Nursing. Clinical research sites are located in Baltimore City, Maryland, as well as sites in Brazil, South Africa, India, and other TB high burden countries. http://tbcenter.jhu.edu/ 

You can also view this press release on the IMPAACT4TB website. 

Johannesburg, 25 January 2021- The Aurum Institute, in collaboration with the International AIDS Society (IAS), will present the inaugural Gita Ramjee Prize at the upcoming HIV Research for Prevention Conference (HIVR4P // Virtual). The award, given in memory of Aurum’s late Chief Scientific Officer, Professor Gita Ramjee, will recognise leading female scientists in the field of HIV prevention research who demonstrate the principles and practices Prof Ramjee embodied in her life and career: a commitment to generate evidence, uplift disadvantaged communities and promote gender transformation.

The award will be given to a top-scoring author of an abstract to be presented at HIVR4P // Virtual, as part of the Thursday 28 January plenary session at the conference.

Prof Ramjee was a long-time member of the IAS, who dedicated her life to HIV prevention and treatment research and contributed substantially to advancing HIV prevention among women in South Africa.

Prof Ramjee passed away on 31 March 2020 due to COVID-19 related complications leaving behind an extensive body of work. She published more than 200 research articles and was a reviewer and editor of several scientific journals and a member of several local and international committees and advisory groups. Over the years she received numerous awards including, the European Development Clinical Trials Partnerships (EDCTP) Outstanding Female Scientist Award, International Microbicide Conference Lifetime Achievement Award and the South African Medical Research Council (MRC) Scientific Merit Gold Medal Award.

Prior to taking up her appointment as Chief Scientific Officer: HIV Prevention, at Aurum, Prof Ramjee was Chief Specialist Scientist and Director of the HIV Prevention Research Unit at the MRC. She held Honorary Professorships at the London School of Hygiene and Tropical Medicine, the University of Washington in Seattle and the University of Cape Town.

“She was a bold and compassionate leader in the response to HIV. She firmly believed in health as a fundamental human right. Her ground-breaking research in HIV prevention contributed hugely to the global response to HIV and AIDS,” said Professor Gavin Churchyard, Group CEO of The Aurum Institute.

Prof Linda-Gail Bekker, IAS Past President described Prof Ramjee as, “An unapologetic champion for South African women. She combined passion with a beautiful, elegant spirit.”

The winner of the inaugural Gita Ramjee Prize will be announced at the opening plenary of the IAS 4th HIV Research for Prevention Conference, taking place virtually on 28 January 2021. 

For more information contact Nosipho Mngoma, Communications Specialist, The Aurum Institute, +27 72 541 8282, This email address is being protected from spambots. You need JavaScript enabled to view it.  

About The Aurum Institute

Established in 1998, the Aurum Institute is an African Health Impact organisation whose mission is to improve the health of people and communities living in poverty through innovation in global health research, systems, and delivery. It is rooted in Africa and is dedicated to researching, supporting, and implementing innovative, integrated approaches to Global Health. Its headquarters are in South Africa with offices in the USA, Switzerland, Ghana, Lesotho and Mozambique. The Aurum Institute has developed itself into a leader in the field of TB and HIV, bridging the worlds of research, policy, and implementation for impact.

About the IAS

The International AIDS Society (IAS) leads collective action on every front of the global HIV response through its membership base, scientific authority and convening power. Founded in 1988, the IAS is the world’s largest association of HIV professionals, with members in more than 170 countries. Working with its members, the IAS advocates and drives urgent action to reduce the impact of HIV. The IAS is also the steward of the world’s most prestigious HIV conferences: The International AIDS Conference, the IAS Conference on HIV Science, and the HIV Research for Prevention Conference.

About HIVR4P

HIVR4P fosters interdisciplinary knowledge-exchange on HIV vaccines, microbicides, PrEP, treatment as prevention and biomedical interventions as well as their related social and behavioral implications. The great strength of HIVR4P is the participation of researchers, policymakers, implementers and advocates working across the spectrum of biomedical interventions and scientific disciplines informing state-of-the-art HIV prevention from pre-clinical research through to implementation.