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

PHASE3UnknownINTERVENTIONAL
Enrollment

500,000

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

January 31, 2022

Study Completion Date

June 30, 2023

Conditions
SARS CoV 2 Infection
Interventions
BIOLOGICAL

Booster vaccine

"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."

Trial Locations (31)

1050

RECRUITING

Mzansi Ethical Research Centre, Middleburg

1632

RECRUITING

The Aurum Institute: Tembisa Clinical Research Centre, Johannesburg

1809

RECRUITING

Perinatal HIV Research Unit Kliptown, Johannesburg

1862

RECRUITING

Perinatal HIV Research Unit (PHRU), SOWETO, Johannesburg

2000

RECRUITING

Clinical HIV Research Unit (CHRU),, Johannesburg

2059

RECRUITING

The Aurum Institute Clinical Research Centre, Pretoria, Pretoria

2571

RECRUITING

The Aurum Institute Klerksdorp Clinical Research Centre, Klerksdorp

3370

RECRUITING

Qhakaza Mbokodo Research Clinic, Ladysmith

3660

RECRUITING

Botha's Hill Clinical Research Site, Bothas Hill

4001

RECRUITING

CAPRISA eThekwini Clinical Research Site, Dr, Durban

4030

RECRUITING

Chatsworth Clinical Research Site, Durban

4400

RECRUITING

Tongaat Clinical Research Site, Dr, Tongaat

5100

RECRUITING

Nelson Mandela Academic Clinical Research Unit (NeMACRU), Mthatha

6001

RECRUITING

PHOENIX Pharma Pty Ltd, Port Elizabeth

6529

RECRUITING

TASK Eden, George

6850

RECRUITING

South African Vaccine Initiative (SATVI), Worcester

7100

RECRUITING

TASK Applied Science, Delft Day Hospital Premises, Cape Town

RECRUITING

TASK Applied Science, Dr Ivans Toms Clinic Premises, Cape Town

7505

RECRUITING

FAMCRU (Family Clinical Research Unit),, Cape Town

7530

RECRUITING

TASK Applied Science, Brooklyn Chest Hospital Premises, Cape Town

RECRUITING

TASK Central, Cape Town

RECRUITING

TASK Clinical Research Centre, Cape Town

7781

RECRUITING

Emavundleni Research Centre, Cape Town

7925

RECRUITING

Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital, Cape Town

7975

RECRUITING

Desmond Tutu Health Foundation - Masiphumelele Research Office, Cape Town

9300

RECRUITING

Josha Research, Bloemfontein

0000

RECRUITING

MeCRU Clinical Research Unit, Pretoria

0152

RECRUITING

Setshaba Research Centre,, Pretoria

Unknown

RECRUITING

Ndlovu Research Centre, Pretoria

RECRUITING

CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza, Durban

0299

RECRUITING

The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence, Rustenburg

All Listed Sponsors
collaborator

National Department of Health of South Africa

UNKNOWN

collaborator

National Institute of Communicable Diseases - NICD

UNKNOWN

collaborator

KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP

UNKNOWN

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Hutchinson Center Research Institute of South Africa (HCRISA)

UNKNOWN

collaborator

Janssen Vaccines & Prevention B.V.

INDUSTRY

collaborator

Bio Analytical Research Corporation

INDUSTRY

collaborator

Dis-Chem Pharmacy

UNKNOWN

collaborator

BioVac

UNKNOWN

collaborator

Biocair

UNKNOWN

collaborator

Right to Care

OTHER

collaborator

Clinical Laboratory Services

OTHER

collaborator

Institute of Infectious Disease and Molecular Medicine

UNKNOWN

lead

Wits Health Consortium (Pty) Ltd

OTHER