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CoVPN 3008 Ubuntu

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

Primary Objectives

  1. to assess the relative risk of symptomatic COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen vs. in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose.
  2. to assess the relative risk of severe COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen vs. in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose.
  3. to assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up.
  4. to assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up.
  5. to assess the safety and tolerability of mRNA-1273 and mRNA-1273.222 in adults who are at risk of severe COVID-19 in both the pre-Month 6 and post-Month 6 stages.

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 please email rhicomms@wrhi.ac.za

Study Brief

CoVPN 3008 Ubuntu

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