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

Phase 3

• Conditions: SARS CoV 2 Infection

• Registration Number: NCT05148845
• Lead Sponsor: Wits Health Consortium (Pty) Ltd

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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study Start: 2021-11-10
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-04
• Study First Posted: 2021-12-08
• Primary Completion: 2022-01-31
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500000

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
To monitor safety in homologous boosts	24 Months	All SAEs and events of special interest will be collected and reported.
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
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.

Trial Locations

Locations (31)

Nelson Mandela Academic Clinical Research Unit (NeMACRU); 🇿🇦 Mthatha, Eastern Cape, South Africa

PHOENIX Pharma Pty Ltd; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Josha Research; 🇿🇦 Bloemfontein, Free State, South Africa

The Aurum Institute: Tembisa Clinical Research Centre; 🇿🇦 Johannesburg, Gauteng - South, South Africa

Perinatal HIV Research Unit Kliptown; 🇿🇦 Johannesburg, Gauteng - South, South Africa

Perinatal HIV Research Unit (PHRU), SOWETO; 🇿🇦 Johannesburg, Gauteng, South Africa

Clinical HIV Research Unit (CHRU),; 🇿🇦 Johannesburg, Gauteng, South Africa

MeCRU Clinical Research Unit; 🇿🇦 Pretoria, Gauteng, South Africa

Setshaba Research Centre,; 🇿🇦 Pretoria, Gauteng, South Africa

The Aurum Institute Clinical Research Centre, Pretoria; 🇿🇦 Pretoria, Gauteng, South Africa

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