Phase 1 Clinical Ttrial of HIV Vaccine Starts in Africa to Evaluate Immune Responses to Highly Networked HIV T-Cell Epitopes
HARARE, ZIMBABWE, ROME, ITALY, NEW YORK, NY, AND CAMBRIDGE, MA / ACCESS Newswire / August 4, 2025 / The Mutala Trust, ReiThera Srl (ReiThera), the Ragon Institute of Mass General Brigham, MIT, and Harvard (the Ragon Institute), and IAVI are pleased to announce that the first doses of an investigational HIV vaccine candidate have been administered. The vaccine candidate, Gorilla Adenovirus Vectored HIV Networked Epitopes Vaccine (GRAdHIVNE1), was first administered on July 28, 2025, at the Mutala Trust clinical trial site in Harare, Zimbabwe. This effort is made possible by a global collaboration and a team of African principal investigators who will lead the clinical research in South Africa and Zimbabwe (listed below). Vaccine immunogenicity will also be assessed locally by a network of state-of-the-art African research institutes: Cape Town HVTN Immunology Laboratory in Cape Town, African Health Research Institute in Durban, and the National Institute for Communicable Diseases in Johannesburg, South Africa.
This Phase 1, first-in-human clinical trial will enroll approximately 120 healthy adults aged 18-50 years, including 48 people living with HIV who are virally suppressed on antiretroviral therapy (ART). The trial is designed to assess the safety and immunogenicity of the vaccine candidate in people living with and without HIV. Participants will receive either one or two doses of the investigational vaccine or a placebo and will be monitored over a period of 19 months for safety and immune responses.
This clinical trial, IAVI C114, is sponsored by IAVI. GRAdHIVNE1 has been made possible by a collaborative effort. ReiThera developed the GRAd viral vector platform and manufactured the vaccine candidate, while the Ragon Institute designed the immunogen using novel strategies to identify protective HIV epitopes and facilitate their targeting by T cells. This clinical program is funded by the Gates Foundation.
The IAVI C114 clinical trial is taking place at three clinical trial sites: the Mutala Trust Clinical Trial Site, in Harare, Zimbabwe; the Desmond Tutu Health Foundation (DTHF), in Cape Town, South Africa; and the Africa Health Research Institute (AHRI), in Durban, South Africa. To determine the vaccine candidate's potential for relevance in sub-Saharan Africa, where disease burden is greatest, it is essential that the candidate be tested within communities affected by the epidemic.
"This is a landmark moment for South Africa, Zimbabwe, and the continent. It shows the power of true partnership: IAVI's sponsorship, ReiThera's GRAd technology, the Ragon Institute's innovative immunogen built on decades of science, and African investigators co-leading every phase of the trial. We are edging closer to an HIV vaccine, made possible by global collaboration, with clinical trials conducted in Africa, for Africa, and for the world." said Dr. Tariro Makadzange, Clinical Trial Lead, Mutala Trust.
"This trial represents the future of vaccine development, rooted in Africa, built through global partnerships, and designed for the communities most affected by HIV," said Dr. Vincent Muturi-Kioi, HIV Vaccines Product Development Team Lead at IAVI.
The vaccine candidate is designed to engage the immune system to recognize and target critical structural regions of HIV using a clinically validated, potent, T cell-inducing GRAd vector. This approach will be evaluated to assess the ability of the vaccine candidate to direct strong CD8+ T cell immune responses towards these vulnerable viral regions.
"We are thrilled to be moving insights from our long-term studies of spontaneous elite controllers of HIV toward the development of GRAdHIVNE1 and its testing in Africa. We are truly grateful to the network of global and African partners that have come together to make the IAVI C114 trial a reality," said Dr. Gaurav Gaiha, Associate Professor of Medicine at Harvard Medical School and Principal Investigator at the Ragon Institute of Mass General Brigham, MIT, and Harvard.
Because CD8+ T cells induced by this vaccine hold promise for targeting HIV-infected cells, this clinical trial will also assess the safety and immune response in people living with HIV. These data will be used to assess the suitability of the vaccine candidate for the development of investigational HIV therapeutic and curative interventions.
"We are enormously pleased with the launch of this Phase 1 trial representing the result of a successful global partnership," said Stefano Colloca, CEO and co-Founder of ReiThera. "This candidate HIV vaccine, built on our GRAd platform, holds great promise to trigger a strong CD8 response targeting vulnerable viral regions."
Principal Investigators Leading Clinical Trial Sites:
Tariro Makadzange, Mutala TrustTheodorah Rirhandzu Ndzhukule, DTHFLimakatso Lebina, AHRI
About IAVI
IAVI is a global nonprofit scientific organization that works to develop vaccines and antibodies to prevent HIV and other infectious diseases, with a focus on innovation and equitable access. IAVI is the sponsor of this trial. Read more at www.iavi.org.
IAVI media contact
Heather Teixeirahteixeira@iavi.org
About Mutala Trust
Mutala Trust is founding member of Africa Clinical Research Network (ACRN) and is a site based in Harare, Zimbabwe. It is known for conducting high-quality, ethically sound clinical trials addressing diseases that affect African communities. Mutala is the clinical lead site for the study.
Mutala Trustmedia contact
coms@acrnhealth.com
About ReiThera Srl.
ReiThera Srl, an Italian CDMO specializing in technology and process development as well as GMP manufacturing of viral vectors for genetic vaccines and advanced therapies, is the developer and owner of the GRAd platform used for this HIV vaccine.
ReiThera media contact
communication@reithera.com
About the Ragon Institute of Mass General Brigham, MIT, and Harvard
The Ragon Institute of Mass General Brigham, MIT, and Harvard was established with a collaborative scientific mission among these institutions that brings scientists, clinicians and engineers together to harness the immune system to combat and cure human disease. They contributed to vaccine design. For more information, visit www.ragoninstitute.org
Ragon Institutemedia contact
ragoncommunications@mgh.harvard.edu
SOURCE: IAVI
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
3 hours ago
- Medscape
Novel Tuberculosis Shots May Benefit HIV-Positive Population
TOPLINE: A two-dose regimen of the M72/AS01 E-4, a recombinant fusion protein tuberculosis vaccine candidate, demonstrated acceptable safety and immunogenicity in virally suppressed, antiretroviral therapy (ART)-treated adolescents and adults living with HIV, showing strong antibody and CD4 T-cell responses. METHODOLOGY: Researchers conducted a randomized, phase 2 trial in South Africa to evaluate the safety and immunogenicity of the investigational M72/AS01 E-4 tuberculosis vaccine, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A) and AS01 E-4 adjuvant, in people living with HIV. tuberculosis vaccine, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A) and AS01 adjuvant, in people living with HIV. Overall, 401 participants — each on ART for ≥ 3 months with HIV viral loads < 200 copies per mL and CD4 T-cell count ≥ 200 cells per µL — were randomly assigned to receive either the M72/AS01 vaccine (n = 201; mean age, 29.4 years; 87% women) or placebo (n = 200; mean age, 29.6 years; 88% women), on days 1 and 29. Primary endpoints were the vaccine's reactogenicity and safety, assessed via solicited adverse events (AEs) within 7 days, unsolicited AEs within 28 days, and serious AEs throughout the trial. Immunogenicity was evaluated by measuring M72-specific immunoglobulin G antibody concentrations on days 1, 29, 57, 210, and 390, as well as M72-specific CD4 and CD8 T-cell responses. TAKEAWAY: Vaccine-related AEs occurred more frequently in the vaccine group (12%) than in the placebo group (6%), primarily due to a higher rate of injection-site reactions in the vaccine group (8% vs 1%). Two severe unsolicited AEs related to the vaccine were reported — a case each of dizziness and injection-site erythema, but no participant discontinued the trial or died due to AEs. Nine serious AEs occurred — four in the vaccine group (COVID-19, tibia fracture, spontaneous abortion, or psychotic disorder) and five in the placebo group (COVID-19, anal abscess, spontaneous abortion, substance-induced psychotic disorder, or physical assault); none was related to the vaccine. In the vaccine group, the geometric mean concentration of antibodies against M72 increased from the baseline level to 13.28 EU/mL by day 29, peaked at 479.70 EU/mL by day 57, and then declined to 32.43 EU/mL by day 390 — yet remained above prevaccination levels. No such increase was observed in the placebo group. The M72-specific CD4 T cells expressing interferon gamma or interleukin-2 was significantly higher in the vaccine group than in the placebo group at both day 57 and day 390 (P < .0001). IN PRACTICE: 'In conclusion, a two-dose regimen of M72/AS01 E-4 vaccine, administered 1 month apart, was well-tolerated, with an acceptable safety profile, and was immunogenic in virally suppressed, ART-treated people living with HIV aged 16-35 years,' the authors wrote. SOURCE: The study was led by Alemnew F. Dagnew, MD, Gates Medical Research Institute, Cambridge, Massachusetts. It was published online on July 1, 2025, in The Lancet HIV. LIMITATIONS: The trial population was restricted to people living with HIV who achieved viral suppression through ART, potentially limiting the generalizability of the results to those not on ART, not adhering to treatment, or newly diagnosed with HIV. Additionally, most participants were women, which may have affected overall trial outcomes given the higher risk for tuberculosis among men. DISCLOSURES: The study was funded by the Gates Foundation and the Wellcome Trust. Several authors were employees of the Gates Medical Research Institute during the trial. Some authors also received financial aid from other organizations, including Wellcome, UK Research and Innovation, Cancer Research UK, and TB Alliance. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Vox
4 hours ago
- Vox
What happens when we lose global health data?
is a fellow for Future Perfect. He reports on global health, science, and biomedicine, focusing on how policies and systems shape progress. A census enumerator, right, talks with a Maasai woman during the population and housing census, the first time being conducted digitally, at a village in Engikaret on August 23, 2022. AFP via Getty Images When President Donald Trump and Elon Musk fed the US Agency for International Development into the wood chipper earlier this year, one of the lesser-known casualties was the shutdown of an obscure but crucial program that tracked public health information on about half of the world's nations. For nearly 40 years, the Demographic and Health Surveys (DHS) Program has served as the world's health report card. In that time, it has carried out over 400 nationally representative surveys in more than 90 countries, capturing a wide range of vital signs such as maternal and child health, nutrition, education levels, access to water and sanitation, and the prevalence of diseases like HIV and malaria. Taken together, it offered perhaps the clearest picture ever compiled of global health. And that clarity came from how rigorous these surveys were. Each one started with a globally vetted blueprint of questions, used by hundreds of trained local surveyors who went door-to-door, conducting face-to-face interviews in people's homes. The final, anonymized data was then processed by a single contractor ICF International, a private consulting firm based in Reston, Virginia, which made the results standardized and comparable across countries and over time. Its data powered global estimates from institutions like the Institute for Health Metrics and Evaluation, which in turn shaped public health policy, research, and funding decisions around the world. 'If DHS didn't exist, comparing anemia across countries would be a PhD thesis,' said Doug Johnson, a senior statistician at the nonprofit IDinsight. Crucially, DHS also tracked things few other systems touched, like gender-based violence, women's autonomy, and attitudes toward domestic abuse. Doctor's offices aren't representative and only capture folks who can access a formal health care system. Also, since DHS data is anonymized, unlike a police report, responders don't have to fear intervention if they don't want it. 'You can't get answers from other sources to sensitive questions like the ones DHS posed,' said Haoyi Chen from the UN Statistics Division, pointing to one example: Is a husband justified in beating his wife if she burns the food? Then, earlier this year, DHS was shut down. The decision came as part of the Rescissions Act of 2025, a bill passed in June that clawed back $9.4 billion from foreign aid and other programs. Eliminating DHS saved the government some $47 million a year — only about 0.1 percent of the total US aid budget, or half the cost of a single F-35 fighter jet. Future Perfect Explore the big, complicated problems the world faces and the most efficient ways to solve them. Sent twice a week. Email (required) Sign Up By submitting your email, you agree to our Terms and Privacy Notice . This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. That tiny budget cut has had immediate consequences. The move halted around 24 in-progress country surveys – 10 of which were just short of final publication, and three in Ethiopia, Guinea, and Uganda that were stopped mid-fieldwork. The program's public-facing website remains up, but the machinery behind it is gone. With no one to approve new applications, the process for researchers to access the underlying microdata has ground to a halt. How the DHS has saved lives The shutdown isn't just about numbers on a spreadsheet. Here's how DHS data has shaped policy and saved lives across the globe. Guinea: DHS data was used to help tailor the rollout of the new malaria vaccine India: The 2019–2021 national survey (India's version of the DHS) showed a stark gap in menstrual hygiene between urban and rural areas, which prompted a new national policy to address the disparity. Nepal: A 2016 DHS survey revealed stagnating maternal mortality rates. This spurred the government to enhance its Safe Motherhood Program , resulting in more women delivering babies in health facilities rather than homes — and fewer women dying in childbirth. Nigeria: DHS surveys showed child marriage rates as high as 76 percent in some states. Advocates used that as evidence to successfully push local governments to strengthen their laws against the practice. There will also be long-term damage. When governments or aid organizations can no longer see exactly where children are malnourished, where malaria outbreaks are quietly spreading, or where mothers are dying in childbirth, they can't effectively target life-saving interventions, leaving the most vulnerable populations to pay the price. For 24 countries, including the Democratic Republic of Congo and Mali, the DHS was the sole data source for the UN's official maternal mortality estimates. Going forward, 'it would just be basically estimates that are based on other countries' data,' says Saloni Dattani, a editor on science and global health at Works in Progress magazine and 2022 Future Perfect 50 honoree. 'We just wouldn't know.' Without the data DHS provided, foreign aid becomes less effective, and less accountable 'We have no way of externally or objectively estimating the positive impact that those [aid] programs are having, or negative,' said Livia Montana, the former deputy director of the DHS Program, who is now a survey director for the Understanding America Study at the University of Southern California. Naturally, the global health community has been scrambling to plug the enormous gap. The Gates Foundation recently committed $25 million in emergency funding to rescue some ongoing surveys, and Bloomberg Philanthropies has also stepped in with a separate commitment to support the effort. This funding is a crucial lifeline, but only a stopgap. The search for a long-term fix has forced a reckoning with the old programs' flaws. Everyone agrees that DHS delivered high-quality, trusted data — but it wasn't perfect. Many experts have criticized it as fundamentally 'donor-driven,' with priorities that didn't always align with the national interests of the countries it surveyed. For instance, the program's historic focus on reproductive health was a direct reflection of the priorities of its primary funder, USAID, and some country officials privately felt the data served the accountability needs of international organizations better than their own immediate planning needs. This has created a central dilemma for the global development community: is it possible to build a new system that is both genuinely country-led and also globally comparable? A lifeline and a reckoning Faced with this data vacuum, an obvious question arises: Why can't other global organizations like the World Health Organization or the United Nations simply step in and take over? It's not out of the question, but it would be really, really difficult. Think of it this way: The DHS Program was like a single, powerful architecture firm that perfected a blueprint and built houses in 90 neighborhoods for 40 years. Because it was a single program managed by private contractor, ICF International, and backed by one major funder, USAID, it could enforce a standardized methodology everywhere it worked. As a for-profit firm, ICF's interest was also financial, it managed the global contract and profited from the work. The UN and WHO, by contrast, act as the global city planners: Their mandate isn't to design and build the houses themselves, but to set the building codes and safety standards for everyone. According to WHO, its role is not to 'directly fund population-based surveys,' but to provide leadership and bring the right stakeholders together. While that mandate may prevent the UN from simply inheriting the old program's work, it makes it an ideal coordinator for the path forward, says Caren Grown, a senior fellow at the Brookings Institution's Center for Sustainable Development. Grown argues that the UN is the only body that can handle the 'heavy lift' of coordinating all the different countries, donors, and organizations. And now that the DHS has been dissolved, both Grown and Chen are now part of a UN task force attempting to establish new internationally agreed-upon standards for how health data should be collected and governed. At the same time, other efforts are more focused on the practical work of implementation rather than on global governance. Montana is leading a coalition to 'rebuild elements of DHS' by creating a global consortium of research institutions that can provide technical support to countries. These efforts were catalyzed by initial conversations hosted by organizations like the Population Reference Bureau, which brought together donors, government agencies, and global data users to grapple with the shutdown's immediate aftermath. Critics argue that for every India, there are a dozen other nations where the program's sudden collapse is proof that a deep, sustainable capacity was never built. Between this mishmash, the most practical development has been a lifeline from the Gates Foundation, which announced a $25 million investment in 'bridge funding.' Separately, in a statement to Vox, Bloomberg Philanthropies confirmed its commitment to fund the completion of an additional 12-country surveys over the next eight months. A source from the Gates Foundation clarified that Bloomberg's commitment is on top of theirs, confirming the two are distinct but coordinated rescue efforts. The Gates Foundation framed its effort as a temporary, stabilizing measure designed to give the global health community a much-needed respite. 'We believe data is — and must remain — a global public good,' said Janet Zhou, a director focused on data and gender equality at the Gates Foundation. 'Our interim support is helping to stabilize 14 ongoing country surveys. … This investment is designed to give global partners and national governments the time and space needed to build a more sustainable, country-led model for health data.' That support is aimed at the most urgent work: finishing surveys that were nearly complete, like in Ethiopia, and reopening the four-decade-old data archive. But rather than giving each respective country the money to complete their ongoing surveys, the Gates funding will be administered by ICF International, the same for-profit firm that ran the original DHS. The decision to work with the existing contractor, ICF International, was a pragmatic one. Continuing with the same implementer was the 'quickest, most affordable way' to prevent waste, and 'multiple host countries have shared a preference' to complete their work with the firm, said a source at the Gates Foundation. A Sudanese mother sits with her children at a shelter in the al-Qanaa village in Sudan's southern White Nile state on September 14, 2021. Ashraf Shazly/AFP via Getty Images It's a powerful argument for triage in an emergency, but it also papers over deeper flaws. Take a look at Nigeria, for example: Fieldwork for its 2023–'24 DHS finished in May 2024, and the questionnaires gathered new estimates of maternal and child deaths. Nigeria also ran a separate study to probe exactly why mothers and children are dying. In principle, the two datasets should dovetail but beyond a headline-numbers report, the full DHS micro-dataset is still in ICF's processing queue — likely frozen after DHS's shuttering. That bottleneck illustrates what critics mean by 'donor-driven.' With barely 3 percent of household surveys in low-income countries fully-financed by the local government, the WHO notes, most nations must rely on 'externally led surveys…limiting continuity and national ownership.' When the donor funding stops, so does the data pipeline. An ICF spokesperson pushed back saying survey priorities were 'primarily shaped by the participating countries.' Yet, of the $25 million that arrived from Gates, a large portion of it will go toward completing large-scale surveys in Nigeria and Kenya, two countries that also happen to be key 'geographies of interest' for the Gates Foundation's own strategic priorities, underscoring how funders still steer the spotlight. Insiders I spoke with described ICF's system as a 'black box,' with key parts of its methodology controlled by the contractor, leaving countries without the capacity to stand on their own. That matters because without home-grown statisticians and know-how, ministries can't rerun surveys or update indicators without outside help. In response, ICF stated that the program has a 'proven track record of building a long-term capacity,' noting that countries like India no longer require its assistance. But critics argue that for every India, there are a dozen other nations where the program's sudden collapse is proof that a deep, sustainable capacity was never built. This dependency creates a fragile system that can, as just happened, collapse overnight, leaving countries unable to continue that work on their own. This unresolved tension brings the debate back to a central question from the UN's Chen. 'DHS has been there for four decades,' she asks, 'and why are we still having this program doing the survey for countries?' Chen's question gets to the heart of the debate. But grappling with the flaws of the past can't get in the way of surviving the present. Existing global health data is already several years out of date due to the pandemic, while crises in maternal mortality and child nutrition continue to unfold. The need is for reliable data now, because the fundamental reality remains: You can't help people you can't see.
Indianapolis Star
6 hours ago
- Indianapolis Star
Trump's tax bill snuck in Planned Parenthood attack that will hurt Indiana women
Reproductive health care is under attack, and recent policy changes threaten to make matters worse. The One Big Beautiful Bill Act, signed into law July 4, includes provisions that go into effect Oct. 1 mandating that Medicaid spending can't be used towards clinics designated as nonprofit organizations that provide family planning services and reproductive care. A federal judge has partially blocked implementation of this provision. If it takes effect, though, that would mean Medicaid users won't be able to access care from Planned Parenthood clinics, among other similar nonprofit health services. While conservatives are hailing this as a pro-life victory, this law is far from saving lives. It targets all of the resources and care that Planned Parenthood provides, including contraception, STI testing, HIV-related care, mental health support and so much more. More from Sadia Khatri: Abortion ban, fetal anomaly and a ticking clock: 'an impossible decision' There's a misconception that Planned Parenthood only provides access to abortions. The organization offers a wide variety of care. In states like Indiana, where abortion is banned, Planned Parenthood doesn't even provide abortions. Some states might use state funding to cover abortion services for Medicaid enrollees, but federal dollars do not pay for abortions. Dr. Tracey Wilkinson, a pediatrician and professor at the Indiana University School of Medicine, thinks the Big Beautiful Bill has less to do with fiscal responsibility and a lot more to do with control. 'The Hyde Amendment has been in place for decades, preventing any federal funds, including Medicaid funds, to ever be used for abortion,' Wilkinson said. 'This issue in the federal budget is not about that. This issue is about preventing people that want to get birth control or want to get testing for sexually transmitted diseases, not being able to go there anymore, and ultimately, hopefully, the goal being that that clinic no longer can keep their doors open and will close.' This bill goes beyond the typical anti-abortion agenda. It's an attack on health care, and it's particularly concerning for a state like Indiana. More from Sadia Khatri: Why young progressives shouldn't give up on Indiana — or flee from it Many Indiana counties are considered maternity care deserts, which are defined as counties where there are zero hospitals that offer obstetric care and zero physicians who provide obstetric care. A little under a quarter of Indiana counties are maternity care deserts. An additional fifth of Indiana counties have limited access to obstetric care. Collectively, almost half of the counties in Indiana have limited or no access to obstetric care. Not all Hoosiers can easily get access to reproductive, sexual health and general OB-GYN-related care in Indiana. This bill is only going to exacerbate that. Planned Parenthood last year received 34,403 visits from Hoosiers across 11 health centers, 53% of whom had incomes at or below the federal poverty line. In 35% of cases, patients were insured by Medicaid. Planned Parenthood provided 30,000 family planning visits, 42,000 STI tests, 5,500 HIV tests and 1,300 Pap tests. Federal law threatens all of those services for Medicaid enrollees. For Hoosiers on Medicaid who live in areas where obstetric care is limited or nonexistent, there aren't always alternatives to Planned Parenthood clinics. Planned Parenthood often is the alternative. It's not just Planned Parenthood that's going to be negatively impacted. Indiana could lose 12 rural hospitals, Wilkinson said. When hospitals shut down, health care deserts worsen. This allegedly big and beautiful bill is about taking bodily autonomy and control away from patients and placing it in the hands of elected officials. Limiting access to family-planning and contraceptive resources has ripple effects. 'When you take away people's abilities to decide if and when and how to become a parent, all the downstream impacts are worsened,' Wilkinson said. 'Infant mortality is worsened, maternal mortality is worsened and pregnancies tend to be more complicated.' For Hoosiers enrolled in Medicaid, it's important to be vigilant and aware about your coverage. Dr. Wilkinson recommends regularly checking to make sure you are still enrolled. Rebecca Gibron, a regional CEO for Planned Parenthood, said the organization will continue to build new pathways to care. Planned Parenthood recently increased access to its telehealth services, helping more patients access remote services. "Indiana's reproductive health care landscape is being reshaped by relentless political interference from local and national leaders —designed to limit our freedom to control our own bodies," Gibron said. "But they should know: Planned Parenthood will never stop showing up for our patients." Despite what some politicians and pundits may say about the Big Beautiful Bill, the reality is that people will lose access to healthcare in some way. The outlook on reproductive health in Indiana is only going to get more grim.
