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Sisonke 4 (SHERPA)/ mRNA-1273-P508 - Trial PACTR202310615330649

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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PACTR202310615330649
Phase 3
Recruitment Completed
Trial Details
Pan Africa Clinical Trials Registry • PACTR202310615330649
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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

Study Focus

Sponsor & Location

Moderna Inc; South African Medical Research Council SAMRC

Moderna Moderna Inc; National Department of Health of South Africa; South African Medical Research Council SAMRC; South African National Treasury

South Africa

Timeline & Enrollment

Phase 3

May 24, 2022

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 diseases
Other infestations
Infestation, unspecified
Other specified infestations
Other infectious diseases

Data Source

Pan Africa Clinical Trials Registry

PACTR202310615330649

Non-Device Trial