The Ensemble Study (J&J vaccine)
Study Title: 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.
Date of site activation: November 2020.
Enrolment target: Our site exceeded the target set (450) and enrolled 602 participants, making us the second largest recruiting site among 31 South African sites. We are the only site representing the Limpopo Province. Retention and follow up stats are also exceeding required standards.
Status: Enrolment closed, follow-up on-going.
Ubuntu study (Moderna Vaccine)
Study Title: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern
Date of site activation: Ndlovu Research Centre has been selected to participate in the study and activation is pending.
Enrolment target: The site has been given a total of 261 participants to enroll. Enrolment plan includes pregnant women and HIV positive participants who are less than 40 years and participants over 40 years with at least one co-morbidity.
Status: Pending activation.
An innovative approach is the use of on-site ARV-druglevel testing to be indicative for therapy adherence.
The study is a collaboration between the University Medical Centre Utrecht, the
Amsterdam Medical Centre, both from the Netherlands tin cooperation with University of Witswatersrand, and Ndlovu Research Centre. Leading investigator is Lucas Hermans MD PhD student.
Sisonke study (J&J Vaccine)
Study Title: 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
Date of site activation: February 2021.
Enrolment target: We vaccinated more than 33 000 health care workers for the Limpopo Province under Sisonke study.
Status: Ongoing for breakthrough infections follow up.
• Are people interested in house testing as an early detection method?
• Are people who test HIV positive looking for care & treatment at an early stage
THE IMBOKODO STUDY
HVTN 705/HPX2008 is a collaboration between the HIV vaccine trials network (HVTN) and Janssen Pharmaceuticals, designed to test an HIV preventive vaccine regimen that covers the different types of HIV found across the world. It is a Phase II trial which studies the efficacy and safety of an HIV vaccine on HIV negative women in the age group 18-35.
The study started in November 2017 across approximately 26 sites in 5 countries in sub-Saharan Africa: Ndlovu Research Centre was selected as one of the sites. The number of study visits were extended in 2020 with a confirmed closure date for the study set for June/July 2022. The vaccination phase of the study is complete and currently sites are in the follow up phase.
Date of site activation: December 2017, Enrolment is currently closed, follow-up is on-going. Enrolment target: our site managed to exceed the target set (146) and enrolled 158 participants. Retention and follow up stats are meeting the required standards.
Status: Nearing completion.
COVPN 5001 is a prospective study of acute immune responses to SARS-COV-2 infection. The purpose of this study is to learn more about infection with and recovery from SARS-CoV-2. People who had no symptoms (asymptomatic), mild symptoms, and people who needed to be hospitalized because of more severe symptoms are all eligible for enrolment. Participants must be aged 18 years or older.
The study started in July 2020 across approximately 52 sites globally and Ndlovu Research Centre was selected as one of the sites. A total of 800 participants are required for the study globally.
Date of site activation: December 2020 and recruitment is still ongoing.
Enrolment target: Our site has far exceeded the enrolment target (12), and enrolled 50 participants so far, making it the 3rd highest enrolment site in the world.
Status: Nearing completion.