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

Last updated: July 29, 2022
Sponsor: Wits Health Consortium (Pty) Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05148845
Sisonke Boost Open Label Study
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

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 beincluded.
  • Willingness and ability to comply with vaccination plan and other study procedures.
  • Capable of giving electronic or personal signed informed consent as described inAppendix 5, which includes compliance with the requirements in this protocol.

Exclusion

Exclusion Criteria:

  • Participants who have received boosting vaccination through other means.
  • Any significant acute or chronic medical condition, situation or circumstance that inthe opinion of the PI/designee makes the participant unsuitable for participation inthe study, or jeopardises the safety or rights of the participant
  • Current participation in any other research studies that would interfere with theobjectives of this study. The determination of whether participation in another studywould be exclusionary for a given participant will be made by the PI/designee.
  • Participants with a history of heparin-induced thrombocytopenia or TTS

Study Design

Total Participants: 500000
Study Start date:
November 10, 2021
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)

    Mthatha, Eastern Cape 5100
    South Africa

    Active - Recruiting

  • PHOENIX Pharma Pty Ltd

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Active - Recruiting

  • Josha Research

    Bloemfontein, Free State 9300
    South Africa

    Active - Recruiting

  • Clinical HIV Research Unit (CHRU),

    Johannesburg, Gauteng 2000
    South Africa

    Active - Recruiting

  • Perinatal HIV Research Unit (PHRU), SOWETO

    Johannesburg, Gauteng 1862
    South Africa

    Active - Recruiting

  • MeCRU Clinical Research Unit

    Pretoria, Gauteng 0000
    South Africa

    Active - Recruiting

  • Ndlovu Research Centre

    Pretoria, Gauteng
    South Africa

    Active - Recruiting

  • Setshaba Research Centre,

    Pretoria, Gauteng 0152
    South Africa

    Active - Recruiting

  • The Aurum Institute Clinical Research Centre, Pretoria

    Pretoria, Gauteng 2059
    South Africa

    Active - Recruiting

  • Perinatal HIV Research Unit Kliptown

    Johannesburg, Gauteng - South 1809
    South Africa

    Active - Recruiting

  • The Aurum Institute: Tembisa Clinical Research Centre

    Johannesburg, Gauteng - South 1632
    South Africa

    Active - Recruiting

  • Botha's Hill Clinical Research Site

    Bothas Hill, KWA ZULU Natal 3660
    South Africa

    Active - Recruiting

  • CAPRISA eThekwini Clinical Research Site, Dr

    Durban, KWA ZULU Natal 4001
    South Africa

    Active - Recruiting

  • Qhakaza Mbokodo Research Clinic

    Ladysmith, KWA ZULU Natal 3370
    South Africa

    Active - Recruiting

  • CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza

    Durban, Kwa Zulu Natal
    South Africa

    Active - Recruiting

  • Chatsworth Clinical Research Site

    Durban, Kwa Zulu Natal 4030
    South Africa

    Active - Recruiting

  • Tongaat Clinical Research Site, Dr

    Tongaat, Kwa Zulu Natal 4400
    South Africa

    Active - Recruiting

  • Mzansi Ethical Research Centre

    Middleburg, Mpumalanga 1050
    South Africa

    Active - Recruiting

  • The Aurum Institute Klerksdorp Clinical Research Centre

    Klerksdorp, North WEST Province 2571
    South Africa

    Active - Recruiting

  • Emavundleni Research Centre

    Cape Town, Western CAPE 7781
    South Africa

    Active - Recruiting

  • Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital

    Cape Town, Western Cape 7925
    South Africa

    Active - Recruiting

  • FAMCRU (Family Clinical Research Unit),

    Cape Town, Western Cape 7505
    South Africa

    Active - Recruiting

  • TASK Applied Science, Delft Day Hospital Premises

    Cape Town, Western Cape 7100
    South Africa

    Active - Recruiting

  • TASK Applied Science, Dr Ivans Toms Clinic Premises

    Cape Town, Western Cape 7100
    South Africa

    Active - Recruiting

  • TASK Central

    Cape Town, Western Cape 7530
    South Africa

    Active - Recruiting

  • TASK Clinical Research Centre

    Cape Town, Western Cape 7530
    South Africa

    Active - Recruiting

  • TASK Applied Science, Brooklyn Chest Hospital Premises

    Cape town, Western Cape 7530
    South Africa

    Active - Recruiting

  • TASK Eden

    George, Western Cape 6529
    South Africa

    Active - Recruiting

  • South African Vaccine Initiative (SATVI)

    Worcester, Western Cape 6850
    South Africa

    Active - Recruiting

  • Desmond Tutu Health Foundation - Masiphumelele Research Office

    Cape Town, 7975
    South Africa

    Active - Recruiting

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

    Rustenburg, 0299
    South Africa

    Active - Recruiting

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