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Wits RHI

CoVPN 3008 Ubuntu Study

Infectious Diseases
Vaccine Preventable Diseases

CoVPN 3008 Ubuntu Study: Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.

Study Rationale

The CoVPN 3008 Ubuntu study investigates the efficacy of the mRNA COVID-19 vaccine (mRNA-1273) among populations at increased risk of severe COVID-19, particularly individuals living with HIV (PLWH). This study is critical in regions where SARS-CoV-2 variants pose heightened health risks. It aims to determine effective vaccination regimens that will mitigate the risk of symptomatic and severe COVID-19, with specific consideration for PLWH and those with co-morbidities.

Objectives

The primary objectives of the CoVPN 3008 Ubuntu study are to:

  1. Evaluate Symptomatic COVID-19 Risk – Compare the relative risk of symptomatic COVID-19 in two groups of PLWH: those who receive a 2-dose vaccine regimen and those receiving a 1-dose regimen.
  2. Evaluate Severe COVID-19 Risk – Assess the risk of severe COVID-19 in these groups under different vaccine regimens.
  3. Assess Vaccine Efficacy Post Month 6 – Compare symptomatic COVID-19 rates in participants receiving either mRNA-1273 or mRNA-1273.222 at Month 6.
  4. Compare Severe COVID-19 Post Month 6 – Measure the risk of severe COVID-19 in participants receiving mRNA-1273 vs. mRNA-1273.222.
  5. Assess Safety and Tolerability – Monitor the safety and tolerability of the vaccine regimens in participants throughout both pre- and post-Month 6 stages.

Study Design

This is a multi-center, randomized, double-blind, controlled trial comparing two different dosing regimens (2-dose vs. 3-dose) for the mRNA COVID-19 vaccine in participants at risk for severe disease. Participants receive either mRNA-1273 or mRNA-1273.222 at different stages of the study.

Study Population

The study targets adults aged 18 and older, including:

  • HIV-positive individuals (90% of participants)
  • Those with comorbidities such as hypertension, diabetes, obesity, and chronic conditions
  • Pregnant individuals (prioritized if HIV-positive)

Investigators

  • Prof Sinead Delany-Moretlwe, Principal Investigator
  • Dr Carrie-Anne Mathew, Sub-investigator
  • Dr Nicole Poovan, Sub-investigator

Latest Update

April 2024

For more details about CoVPN 3008 Ubuntu Study please email rhicomms@wrhi.ac.za

Research Brief

CoVPN 3008 Ubuntu Study