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

• Sponsor: Wits Health Consortium (Pty) Ltd (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05148845
• Collaborator: National Department of Health of South Africa (Other), National Institute of Communicable Diseases - NICD (Other), KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP (Other), Fred Hutchinson Cancer Center (Other), Hutchinson Center Research Institute of South Africa (HCRISA) (Other), Janssen Vaccines & Prevention B.V. (Industry), Bio Analytical Research Corporation (Industry), Dis-Chem Pharmacy (Other), BioVac (Other), Biocair (Other), Right to Care (Other), Clinical Laboratory Services (Other), Institute of Infectious Disease and Molecular Medicine (Other)
• Enrollment: 500,000
• Locations: 31
• Anticipated Duration (Months): 18.7
• Patients Per Site: 16129
• Patients Per Site Per Month: 864.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection	Biological: Booster vaccine	Phase 3

Detailed Description

Purpose 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 the investigators will continue to evaluate VE of the Sisonke Boost compared to:

1. Vaccinated populations pre boosts ii) Unvaccinated populations in South Africa.

Study design Open-label, single-arm phase 3B vaccine implementation study

Rationale South Africa is severely affected by the global COVID-19 epidemic, and following the initial prime vaccination among HCWs in the first 4 months of 2021. New data has demonstrated the safety and effectiveness of a booster dose given two months or more after the initial Ad26.COV2.S. This provides the rationale and feasibility for the evaluation of a homologous booster vaccine dose to the cohort of vaccinated Sisonke participants to inform the larger vaccine rollout.

Study participants Sisonke participants age 18 and over working in the South African public and private health care sector (approx N=500 000) who were enrolled in Sisonke and have not subsequently had a further booster vaccine dose.

Study sites Department of Health Vaccine Administration Sites across South Africa supported by the Sisonke (Together) (VAC31518COV3012) Trial Research Site Investigators and Study Staff

Study duration Participants will receive a homologous Ad26.COV2.S (Janssen) booster dose of vaccine at least 6 months post the prime vaccination. The investigators will monitor outcomes utilising the DATCOV surveillance system and NHLS/NICD SARS COV-2 testing databases for up to 2 years post initial vaccination.

Study products Ad26.COV2.S by Janssen administered as a single dose followed by a single booster injection.

Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared with the unboosted Sisonke populations.

Secondary objectives To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared vaccinated and unvaccinated populations of essential workers in South Africa.

• To estimate the incidence of symptomatic SARS CoV-2 infections in Sisonke participants following a boost compared with the unboosted Sisonke populations and general vaccinated and unvaccinated population in South Africa

• To estimate booster dose uptake among Sisonke participants in South Africa

• To monitor the genetic diversity of breakthrough SARS CoV-2 infections.

• To monitor safety in the case of homologous boosts in Sisonke participants.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500000 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-label, single-arm phase 3B vaccine implementation studyOpen-label, single-arm phase 3B vaccine implementation study
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Open-label, Single-arm Phase 3B Implementation Study to Evaluate the Effectiveness of the Homologous Boostof Ad26.COV2.S COVID-19 Vaccine Following the Prime Dose Among Sisonke Participants in South Africa(VAC31518COV30XX)
• Actual Study Start Date: Nov 10, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to unboosted Sisonke participants (single Ad26 vaccine only) [24 Months]

   Rates of hospitalizations and deaths among boosted Sisonke participants versus unboosted Sisonke participants and unvaccinated populations in South Africa

Secondary Outcome Measures

1. To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to the vaccinated and unvaccinated populations (no vaccination) in South Africa. [24 Months]

   Rates of hospitalizations and deaths among boosted Sisonke participants versus unboosted vaccinated and unvaccinated populations in South Africa

2. To estimate the incidence of symptomatic SARS CoV-2 infections among boosted Sisonke ppts. [24 months]

   Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records. Rates of severe disease in Sisonke participants who are found to be RT-PCR positive at any time up to 2 years post prime vaccination

3. To monitor the genetic diversity of breakthrough SARS CoV-2 infections [24 Months]

   Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories.

4. To estimate booster vaccine uptake among Sisonke participants in South Africa [24 Months]

   Proportion of Sisonke participants approached for study participation taking part in the boost study and receiving the booster vaccine

5. To monitor safety in homologous boosts [24 Months]

   All SAEs and events of special interest will be collected and reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Age 18 and older

• All Sisonke participants

• Received a priming Ad26.SARS.COV.2.S vaccination as part of the Sisonke study at least 6 months prior

• Participants who are pregnant or report breastfeeding at the time of enrolment may be included.

• Willingness and ability to comply with vaccination plan and other study procedures.

• Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.

Exclusion Criteria:

• Participants who have received boosting vaccination through other means.

• Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant

• Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee.

• Participants with a history of heparin-induced thrombocytopenia or TTS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nelson Mandela Academic Clinical Research Unit (NeMACRU)	Mthatha	Eastern Cape	South Africa	5100
2	PHOENIX Pharma Pty Ltd	Port Elizabeth	Eastern Cape	South Africa	6001
3	Josha Research	Bloemfontein	Free State	South Africa	9300
4	The Aurum Institute: Tembisa Clinical Research Centre	Johannesburg	Gauteng - South	South Africa	1632
5	Perinatal HIV Research Unit Kliptown	Johannesburg	Gauteng - South	South Africa	1809
6	Perinatal HIV Research Unit (PHRU), SOWETO	Johannesburg	Gauteng	South Africa	1862
7	Clinical HIV Research Unit (CHRU),	Johannesburg	Gauteng	South Africa	2000
8	MeCRU Clinical Research Unit	Pretoria	Gauteng	South Africa	0000
9	Setshaba Research Centre,	Pretoria	Gauteng	South Africa	0152
10	The Aurum Institute Clinical Research Centre, Pretoria	Pretoria	Gauteng	South Africa	2059
11	Ndlovu Research Centre	Pretoria	Gauteng	South Africa
12	Botha's Hill Clinical Research Site	Bothas Hill	KWA ZULU Natal	South Africa	3660
13	CAPRISA eThekwini Clinical Research Site, Dr	Durban	KWA ZULU Natal	South Africa	4001
14	Chatsworth Clinical Research Site	Durban	Kwa Zulu Natal	South Africa	4030
15	CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza	Durban	Kwa Zulu Natal	South Africa
16	Qhakaza Mbokodo Research Clinic	Ladysmith	KWA ZULU Natal	South Africa	3370
17	Tongaat Clinical Research Site, Dr	Tongaat	Kwa Zulu Natal	South Africa	4400
18	Mzansi Ethical Research Centre	Middleburg	Mpumalanga	South Africa	1050
19	The Aurum Institute Klerksdorp Clinical Research Centre	Klerksdorp	North WEST Province	South Africa	2571
20	TASK Applied Science, Delft Day Hospital Premises	Cape Town	Western Cape	South Africa	7100
21	TASK Applied Science, Dr Ivans Toms Clinic Premises	Cape Town	Western Cape	South Africa	7100
22	FAMCRU (Family Clinical Research Unit),	Cape Town	Western Cape	South Africa	7505
23	TASK Applied Science, Brooklyn Chest Hospital Premises	Cape town	Western Cape	South Africa	7530
24	TASK Central	Cape Town	Western Cape	South Africa	7530
25	TASK Clinical Research Centre	Cape Town	Western Cape	South Africa	7530
26	Emavundleni Research Centre	Cape Town	Western CAPE	South Africa	7781
27	Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital	Cape Town	Western Cape	South Africa	7925
28	TASK Eden	George	Western Cape	South Africa	6529
29	South African Vaccine Initiative (SATVI)	Worcester	Western Cape	South Africa	6850
30	Desmond Tutu Health Foundation - Masiphumelele Research Office	Cape Town		South Africa	7975
31	The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence	Rustenburg		South Africa	0299

Sponsors and Collaborators

• Wits Health Consortium (Pty) Ltd
• National Department of Health of South Africa
• National Institute of Communicable Diseases - NICD
• KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP
• Fred Hutchinson Cancer Center
• Hutchinson Center Research Institute of South Africa (HCRISA)
• Janssen Vaccines & Prevention B.V.
• Bio Analytical Research Corporation
• Dis-Chem Pharmacy
• BioVac
• Biocair
• Right to Care
• Clinical Laboratory Services
• Institute of Infectious Disease and Molecular Medicine

Investigators

• Principal Investigator: Glenda Gray, MBChB, Non-Executive Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wits Health Consortium (Pty) Ltd
• ClinicalTrials.gov Identifier: NCT05148845
• Other Study ID Numbers: Sisonke Boost Open Label Study
• First Posted: Dec 8, 2021
• Last Update Posted: Aug 1, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 1, 2022