PACTR202310615330649

Sisonke 4 (SHERPA)/ mRNA-1273-P508

Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.SCOVID-19 vaccine among health care workers in South Africa
Moderna Inc; South African Medical Research Council SAMRC·Phase 3·Pan Africa Clinical Trials RegistryRecruitment Completed
Study focus
Sponsor & location
Primary sponsor
Moderna Inc; South African Medical Research Council SAMRC
Funder
Moderna Moderna Inc; National Department of Health of South Africa; South African Medical Research Council SAMRC; South African National Treasury
Location
South Africa
Timeline & enrollment
Phase
Phase 3
Start date
May 24, 2022
End date
Jan 01, 1900
Summary

South Africa is severely affected by the global COVID-19 pandemic. As part of the Sisonke study, HCWs received a single dose of Ad26.COV2.S vaccine between 17 February and 17 May 2021, and were then offered a second dose between 8 November and 17 December 2021. Immunogenicity studies have since indicated that a heterologous mRNA vaccine boost strategy may elicit stronger neutralizing antibody responses among people who received the Ad26.COV2.S and other vector-based vaccines.The purpose of the study is therefore to evaluate the effectiveness of the heterologous mRNA-1273 (Moderna) boost against COVID-19 infections and severe disease (including deaths) among health care workers (HCWs) who participated in the Sisonke trial and received either a single dose or two doses of Ad26.COV2.S (Janssen, Johnson and Johnson) COVID-19 vaccine as their primary vaccination. Furthermore, the study aims to collect additional safety and immunogenicity data on the heterologous mRNA-1273 boost among Sisonke participants.

ICD-10 classifications
Certain infectious and parasitic diseasesOther infestationsInfestation, unspecifiedOther specified infestationsOther infectious diseases
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202310615330649
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR202310615330649 through Pure Global AI's free database. This Phase 3 trial is sponsored by Moderna Inc; South African Medical Research Council SAMRC and is currently Recruitment Completed. The study focuses on Infections and Infestations.

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