CoVPN 3008 Ubuntu Study

Study Overview

The CoVPN 3008 Ubuntu study is a multi-center, randomized, efficacy study focused on evaluating the COVID-19 mRNA vaccine (mRNA-1273) in regions impacted by SARS-CoV-2 variants of concern. The study aims to assess the vaccine’s efficacy among populations at increased risk of severe COVID-19, particularly people living with HIV (PLWH), and those with comorbidities like obesity and diabetes.

Study Rationale

This study is essential in regions where SARS-CoV-2 variants pose significant health risks. It investigates the effectiveness of vaccination regimens to reduce symptomatic and severe COVID-19, with particular attention to the challenges faced by PLWH and individuals with other health conditions.

Study Objectives

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

Evaluate Symptomatic COVID-19 Risk: Compare the risk of symptomatic COVID-19 in PLWH receiving a 2-dose versus a 1-dose vaccine regimen.
Evaluate Severe COVID-19 Risk: Assess the risk of severe COVID-19 in these groups under different vaccine regimens.
Assess Vaccine Efficacy Post Month 6: Compare symptomatic COVID-19 rates between mRNA-1273 and mRNA-1273.222 participants at Month 6.
Compare Severe COVID-19 Post Month 6: Measure the risk of severe COVID-19 in participants receiving mRNA-1273 versus mRNA-1273.222.
Assess Safety and Tolerability: Monitor safety and tolerability 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 will 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)
Individuals 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