By Charmaine Ndlela
South Africa has enrolled the first 20 HIV-negative volunteers in BRILLIANT 011, a first-in-human clinical trial of an HIV vaccine.
The trial is underway at the Desmond Tutu HIV Foundation (DTHF) site at Groote Schuur Hospital in Cape Town. Participants were enrolled on 4 February 2026.
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BRILLIANT 011 is a partnership between the South African Medical Research Council (SAMRC), the Desmond Tutu HIV Foundation and the Wits Health Consortium.
“This trial marks a major milestone in African-led HIV vaccine research,” the SAMRC said in a statement. “BRILLIANT 011 brings renewed hope that an HIV vaccine developed through African science for African populations is becoming increasingly possible.”
SAMRC sponsor representative Professor Glenda Gray described the study as groundbreaking.
“This is a first-in-human, first-in-Africa study,” Gray said. “It forms part of an HIV discovery programme aimed at inducing broadly neutralising antibodies in vaccinated individuals.”
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She explained that the vaccine targets a specific region of the HIV envelope and includes an adjuvant designed to strengthen the immune response.
“The aim is to teach the immune system to produce antibodies capable of neutralising the virus,” Gray said.
If early results show a strong immune response, researchers will move to larger trials and refine the vaccination regimen.
“This will help determine whether we need a next-generation vaccine or whether the current version can be optimised,” she said.
The vaccine strategy is both preventative and potentially therapeutic. Researchers will explore its ability to prevent HIV infection and assess whether similar approaches could improve outcomes for people living with HIV, including reducing lifelong dependence on antiretroviral therapy or contributing to functional cure research.
The trial is highly intensive, involving frequent blood sampling and advanced laboratory analysis to track immune responses at a cellular level.
“We conduct single-cell and B-cell analytics to understand exactly how the immune system responds,” Gray said. “This allows us to refine vaccine design and engineer improved immunogens if necessary.”
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Gray noted that South Africa has participated in HIV vaccine research since 2005 and highlighted the collaborative nature of the consortium, which includes scientists from South Africa, Nigeria, Uganda, Kenya, Tanzania, Zimbabwe, Zambia and Mozambique.
The initiative is also notable for being predominantly led by African women scientists, with the SAMRC spearheading the first trial.
South Africa continues to carry one of the world’s heaviest HIV burdens. As of 2024, an estimated 8 million to 8.15 million people were living with HIV, with about 6.2 million receiving treatment.
According to recently released estimates from Thembisa, a leading mathematical model tracking HIV and TB trends, the number of people living with HIV in South Africa has reached eight million for the first time. Research by Dr Leigh Johnson of the University of Cape Town has also pointed to declining condom use, underscoring ongoing prevention challenges.
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While BRILLIANT 011 remains in its early stages, researchers say it represents an important step toward strengthening long-term HIV prevention and treatment strategies.
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