Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa.

This study evaluated the effectiveness of the Moderna COVID-19 mRNA vaccine (mRNA-1273) as a booster for individuals previously vaccinated with one or two doses of the Ad26.COV2.S (J&J) vaccine. It compared infection rates, severe COVID-19 cases, hospitalizations, and deaths among boosted and non-boosted Sisonke participants. Additionally, the study assessed the safety of the mRNA-1273 booster in the South African context, providing crucial data for SAHPRA and regulators.

A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection

Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa.

The CRS Investigators and Study Staff worked in collaboration with the National Department of Health Vaccine Administration Centres across South Africa, providing support in vaccinating both public and private sector Health Care Workers.

Healthcare workers (HCWs) and other frontline responders faced increased exposure to SARS-CoV-2, with HCWs in South Africa being 4-7 times more likely to contract COVID-19. Over 55,000 HCWs tested positive, leading to severe illness, hospitalizations, and staff shortages that strained the healthcare system. Recognizing their vulnerability, the South African Government prioritized HCWs in phase 1 of the national vaccination rollout. This study, conducted in collaboration with the National Department of Health, assessed the effectiveness of the Ad26.COV2.S vaccine in preventing COVID-19 infections, severe disease, hospitalizations, and deaths among HCWs, first responders, and other essential workers. Lessons from this rollout helped shape future public vaccination strategies in South Africa.

Multicenter, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.

This study evaluates mRNA vaccine effectiveness against COVID-19 and severe illness in areas with the B.1.351 variant, focusing on high-risk groups like those over 40, pregnant women, and people with HIV. Despite reduced efficacy in some vaccines, mRNA vaccines remain highly effective (97%) against severe disease. Using a randomized, double-blind design, the trial will monitor breakthrough infections and sequence emerging variants. Rapid vaccine deployment and safety measures, including health monitoring and critical treatments, will prioritize protecting vulnerable populations.

Open-label, single-arm Phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa

A prospective study of acute immune responses to SARS-CoV-2 infection

Open-label, single-arm phase 3B implementation study to evaluate the effectiveness of the homologous boost of Ad26.COV2.S COVID-19 vaccine following the prime dose among Sisonke participants in South Africa (VAC31518COV30XX)

A total of 3042 healthcare workers were vaccinated with the booster in the district. Ladysmith contributed the largest amount of participants (633).

This study aimed to assess the effectiveness of a single-dose Ad26.COV2.S COVID-19 booster administered at least two months after the initial vaccination among Sisonke participants in South Africa. The study compared vaccine effectiveness (VE) in boosted participants against those who chose not to receive a booster and unvaccinated essential workers.

A Randomized, Double-blind, Placebo-controlled, Phase 3 study to assess to efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

410 participants were Screened and 300 Enrolled. Participants received the J&J vaccine then a booster 24 and 52 months after during COVID lockdown. 

Characterizing SARS-CoV-2-specific immunity in convalescent individuals

A multicenter, randomized, double-blind, placebo-controlled, phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphate adjuvanted Clade C gp140 in preventing HIV-1 infection in women in Sub-Saharan Africa

This study is focused on evaluating the effectiveness, safety, and tolerability of a novel HIV vaccine regimen in HIV-negative women in sub-Saharan Africa. Using a heterologous prime/boost approach, the vaccine combines Ad26.Mos4.HIV with Clade C gp140, an aluminum-phosphate adjuvanted component. The goal is to prevent HIV infection by assessing vaccine efficacy through confirmed HIV-1 diagnoses between the 7-month and 24-month visits.

A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in preventing HIV-1 infection in adults in South Africa

This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South

African adults over 24 months and potentially up to 36 months from enrollment.

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA, and of MF59®- or AS01B-adjuvanted clade C Env protein in various combinations, in healthy, HIV-uninfected adult participants

A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

A follow-on, open-label trial to assess continued safety of and adherence to the Dapirivine (25mg) vaginal ring-004 in healthy, HIV-negative women

This is an observational, long-term follow-up study for participants who become HIV positive during IPM 027. The study will assess the impact, if any, of exposure to a antiretroviral microbicide at the time of infection.

A Multi-Centre, Randomised, Double-Blind, Placebo-controlled Phase III Long-term Safety Trial of Dapivirine Vaginal Matrix Ring in Healthy HIV Negative Women

To assess the safety and efficacy of a silicone elastomer vaginal matrix ring. Vaginal ring containing 25mg dapivirine; one ring inserted once every 4 weeks over 24 months.

The Ring Study reported results early in February 2016 after an independent safety and monitoring board recommended the study proceed to final analysis. It has moved to open-label in South Africa and Uganda. In July, 2016 new analyses announced by MTN at AIDS 2016 found that, among women who appeared to use the monthly ring consistently, HIV risk was cut by at least 56 percent — a statistically significant finding.

A Phase III multi-centre randomized controlled trial to assess the safety and effectiveness of the vaginal microbicide 1% Tenofovir gel in the prevention of Human Immunodeficiency Virus type 1 infection in women, and to examine effects of the microbicide on the incidence of herpes simplex virus type 2 infection.

Tenofovir, an antiretroviral (ARV) drug, prevents HIV from replicating within human cells and is commonly used in tablet form to treat HIV infections. A 1% tenofovir gel, containing the same active ingredient, has been developed as a microbicide for HIV prevention. Studies have demonstrated that vaginal tenofovir gel, applied before and after sex, significantly reduces the risk of HIV infection and genital herpes. FACTS 001 is a follow-up study aimed at confirming the safety and effectiveness of vaginal tenofovir gel, using the same dosing regimen as CAPRISA 004, to further validate its role in HIV prevention.

This is a Phase I/II trial designed to assess and compare the safety of a dapivirine vaginal ring against a placebo vaginal ring when inserted once every 28 days over a 12-week period among healthy, HIV-negative women. IPM 015 also assessed the acceptability of the vaginal ring and enrolled 280 healthy, HIV-negative women at multiple research centres in Kenya, Malawi, Rwanda, South Africa and Tanzania.

This is a Phase I/II clinical trial designed to assess the safety and acceptability of one formulation of dapivirine gel (gel 4759, 0.05% 2.5g) as compared to a matching placebo gel in healthy, HIV-negative women in Kenya, Malawi, Rwanda and South Africa.

The gel was used once a day for a period of six weeks.

The trial used the Daily Monitored Adherence (DMA) design, a model used to help women establish a pattern of routine product use.

This is a cross-sectional and prospective cohort study to estimate the HIV incidence among sexually active women, ages 18 to 35 years, in five sites across South Africa. As part of the cross-sectional component of the study, approximately 800 women at each site were tested for HIV once, with pre- and post-test counseling. Among them, the 300 women who tested HIV-negative at each site were enrolled into a 12-month prospective cohort study, with regular(quarterly) HIV testing and counseling.