The Centre for Infectious Disease Research in Zambia (CIDRZ), in collaboration with the Ministry of Health, conducted a study on the transition to Dolutegravir (DTG)-based first-line antiretroviral therapy (ART) from June 2020 to December 2022.

The study titled DTG-SWITCH: Longitudinal analysis of virologic failure and drug resistance at and after switching to Dolutegravir-based first-line ART implemented at Kanyama, Matero first level hospitals, and Kalingalinga clinic sought to investigate the outcomes of switching people living with HIV to a new treatment called Dolutegravir in Zambia.

It also aimed to understand how well people who switched to this new treatment respond over two years, especially those who had detectable levels of HIV viral load(Viremia) when they switched. Further the study also looked at whether people developed resistance to the new treatment.

The study found that after two years, most people on DTR based treatment had good outcomes. However, those with high viral loads at switching were more likely to experience treatment failure.

In Malawi all people living with HIV were switched to DTG based treatment, regardless of their viral load. However, in Zambia, only those with a viral load below 1000 copies/ml were switched to DTG.

From June 2016 to July 2017, the Centre for Infectious Disease Research in Zambia (CIDRZ) conducted high-quality clinical research through its involvement in the HIV Vaccine Trials Network (HVTN) 111 study, a Phase 1/2A clinical trial.

The trial, titled “A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DNA and of MF59-Adjuvanted Clade C Env Protein, in Healthy, HIV-Uninfected Adult Participants,” was implemented across three countries including Zambia, South Africa, and Tanzania. CIDRZ was among the five clinical research sites involved.

The primary aim of the study was to evaluate the safety, tolerability, and immune response generated by a candidate HIV vaccine. A total of 132 healthy, HIV-uninfected adult participants were enrolled, and 123 (93%) successfully completed all vaccination and follow-up visits.

Findings from the study showed that all vaccine formulations and combinations were safe and well tolerated. There were no serious adverse events, vaccine-related severe side effects, or significant local reactions reported.

In terms of immune response, the combination of DNA and protein vaccines demonstrated a stronger boost to the immune system, which may help reduce the risk of HIV-1 infection. Additionally, the study compared delivery methods, finding that administering the DNA vaccine via Biojector (a needle-free device) followed by a booster injection produced a stronger immune response than the traditional needle and syringe method—though this benefit was not observed when both were given at the same time.

Although the study was conducted several years ago, it remains a strong demonstration of CIDRZ’s technical expertise and its role in global scientific efforts to develop an effective HIV vaccine.

“This trial, conducted over a decade ago, is a testament to CIDRZ’s capacity to implement complex, multi-country research aligned with international standards,” said a CIDRZ spokesperson. “We continue to build on this legacy to support innovative health research in Zambia and beyond.”

The success of the HVTN 111 study highlights CIDRZ’s continued commitment to improving public health through cutting-edge research and international collaboration.

From January 2022 to March 2024, the Centre for Infectious Diseases Research in Zambia (CIDRZ), Matero Clinical Research Site (CRS), conducted the CoVPN 3008 (Ubuntu) Multi-Centre, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.

The study evaluated the safety and effectiveness of the Moderna COVID-19 mRNA vaccine in seven African countries. Participants in the study included adults living with HIV as well as adults with other conditions such as obesity or diabetes, which may also increase the risk of severe COVID-19.

The study assessed how well the COVID-19 mRNA vaccine by Moderna, Inc. helped to prevent COVID-19 illness, including severe illness, among participants.

The CoVPN 3008 (Ubuntu) study is one of the largest prospective studies of a COVID-19 vaccine conducted exclusively in Africa, and the only such trial to enrol a large and diverse population of PLWH, including pregnant persons and individuals with poorly controlled HIV.

The study found that overall hybrid immunity was associated with a significant reduction in the risk of COVID-19 and severe COVID-19 compared to vaccine immunity, but this effect did not seem to hold among PLWH with low CD4 counts or HIV viraemia.

The vaccines also appeared safe and well tolerated in PLWH. Severe COVID-19 was rare in Ubuntu, and most infections were mild or asymptomatic. Importantly, the study identified a subpopulation of participants with persistent SARS-CoV-2 shedding, more often observed among PLWH with a detectable HIV viral load or low CD4 count.

Details of the trial can be found at: https://doi.org/10.1016/j.eclinm.2024.103054.

In 2016, the Centre for Infectious Diseases Research in Zambia (CIDRZ), Clinical Trials Unit conducted the HIV Vaccine Trials Network (HVTN) 120 Clinical trial, a multi-country study, double blind randomised trial. This was a phase 1/2a clinical trial of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein designed to evaluate the safety, tolerability, and immune response of a specific HIV vaccine candidate.

This study is part of the larger efforts by the HVTN, which focuses on developing a safe and effective vaccine to prevent HIV infection.
CIDRZ Clinical Trials Unit completed the study in 2019 and achieved 100% retention. The vaccine candidate was found to be safe and well tolerated. Use of an adjuvant resulted in increased CD4 T-cell and binding antibody responses, but responses were not low and not persistent. Details of the trial can be found at: HVTN 120/ ALVAC-HIV and Protein Dose-Sparing Effect...