Clinical trial NCT05148845: Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: SARS CoV 2 Infection
Lead sponsor: Wits Health Consortium (Pty) Ltd
Sponsor class: OTHER
Collaborators: name: National Department of Health of South Africa
name: National Institute of Communicable Diseases - NICD
name: KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP
name: Fred Hutchinson Cancer Center
name: Hutchinson Center Research Institute of South Africa (HCRISA)
name: Janssen Vaccines & Prevention B.V.
name: Bio Analytical Research Corporation
name: Dis-Chem Pharmacy
name: BioVac
name: Biocair
name: Right to Care
name: Clinical Laboratory Services
name: Institute of Infectious Disease and Molecular Medicine
First posted: 2021-12-08
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single-arm phase 3B vaccine implementation study
Primary purpose: PREVENTION

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

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:

i) 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 24 Months
Secondary outcomes:
measure: 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.
timeFrame: 24 Months
measure: To estimate the incidence of symptomatic SARS CoV-2 infections among boosted Sisonke ppts.
timeFrame: 24 months
measure: To monitor the genetic diversity of breakthrough SARS CoV-2 infections
timeFrame: 24 Months
measure: To estimate booster vaccine uptake among Sisonke participants in South Africa
timeFrame: 24 Months
measure: To monitor safety in homologous boosts
timeFrame: 24 Months
Other outcomes:
Locations:
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Clinical Research Unit (NeMACRU)
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: PHOENIX Pharma Pty Ltd
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Josha Research
state: Free State
city: Johannesburg
country: South Africa
facility: The Aurum Institute: Tembisa Clinical Research Centre
state: Gauteng - South
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit Kliptown
state: Gauteng - South
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU), SOWETO
state: Gauteng
city: Johannesburg
country: South Africa
facility: Clinical HIV Research Unit (CHRU),
state: Gauteng
city: Pretoria
country: South Africa
facility: MeCRU Clinical Research Unit
state: Gauteng
city: Pretoria
country: South Africa
facility: Setshaba Research Centre,
state: Gauteng
city: Pretoria
country: South Africa
facility: The Aurum Institute Clinical Research Centre, Pretoria
state: Gauteng
city: Pretoria
country: South Africa
facility: Ndlovu Research Centre
state: Gauteng
city: Bothas Hill
country: South Africa
facility: Botha's Hill Clinical Research Site
state: KWA ZULU Natal
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site, Dr
state: KWA ZULU Natal
city: Durban
country: South Africa
facility: Chatsworth Clinical Research Site
state: Kwa Zulu Natal
city: Durban
country: South Africa
facility: CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza
state: Kwa Zulu Natal
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic
state: KWA ZULU Natal
city: Tongaat
country: South Africa
facility: Tongaat Clinical Research Site, Dr
state: Kwa Zulu Natal
city: Middleburg
country: South Africa
facility: Mzansi Ethical Research Centre
state: Mpumalanga
city: Klerksdorp
country: South Africa
facility: The Aurum Institute Klerksdorp Clinical Research Centre
state: North WEST Province
city: Cape Town
country: South Africa
facility: TASK Applied Science, Delft Day Hospital Premises
state: Western Cape
city: Cape Town
country: South Africa
facility: TASK Applied Science, Dr Ivans Toms Clinic Premises
state: Western Cape
city: Cape Town
country: South Africa
facility: FAMCRU (Family Clinical Research Unit),
state: Western Cape
city: Cape town
country: South Africa
facility: TASK Applied Science, Brooklyn Chest Hospital Premises
state: Western Cape
city: Cape Town
country: South Africa
facility: TASK Central
state: Western Cape
city: Cape Town
country: South Africa
facility: TASK Clinical Research Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Emavundleni Research Centre
state: Western CAPE
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
state: Western Cape
city: George
country: South Africa
facility: TASK Eden
state: Western Cape
city: Worcester
country: South Africa
facility: South African Vaccine Initiative (SATVI)
state: Western Cape
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation - Masiphumelele Research Office
city: Rustenburg
country: South Africa
facility: The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence
Study officials:
affiliation: Non-Executive Director
name: Glenda Gray, MBChB
role: PRINCIPAL_INVESTIGATOR
References: