Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.

Summary

To evaluate the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine plus a homologous boostwith Ad26.COV2.S COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonkeparticipants; vaccinated; and unvaccinated populations in South Africa

Conditions

• SARS CoV 2 Infection

Interventions

BIOLOGICAL

Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S

To evaluate the effectiveness and safety of the single dose Ad26.COV2.S (Jansen) COVID-19 vaccine plus a homologous boost with Ad26.COV2.S (Janssen) COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonke participants In addition we will continue to evaluate VE of the Sisonke Boost compared to: i) Vaccinated populations pre boosts ii) Unvaccinated populations in South Africa.

DRUG

Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S

Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S

Sponsors & Collaborators

• National Department of Health of South Africa

  collaborator UNKNOWN

• National Institute of Communicable Diseases - NICD

  collaborator UNKNOWN

• KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Hutchinson Center Research Institute of South Africa (HCRISA)

  collaborator UNKNOWN

• Janssen Vaccines & Prevention B.V.

  collaborator INDUSTRY

• Bio Analytical Research Corporation

  collaborator INDUSTRY

• Dis-Chem Pharmacy

  collaborator UNKNOWN

• BioVac

  collaborator UNKNOWN

• Biocair

  collaborator UNKNOWN

• Right to Care

  collaborator OTHER

• Clinical Laboratory Services

  collaborator OTHER

• Institute of Infectious Disease and Molecular Medicine

  collaborator UNKNOWN

• Wits Health Consortium (Pty) Ltd

  lead OTHER

Principal Investigators

• Glenda Gray, MBChB · Non-Executive Director

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-10

Primary Completion

2022-01-31

Completion

2023-06-30

Countries

• South Africa

Study Locations