Sisonke (Together): OPEN LABEL TRIAL COVID-19
Condition: SARS (Severe Acute Respiratory Syndrome)
MeSH terms: Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health
      care workers (HCW) in South Africa
    

Detailed description: 
      Purpose To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among
      health care workers (HCW) as compared to the general unvaccinated population 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, but currently no
      vaccine has been rolled out. The recent promising results of the 'ENSEMBLE' trial conducted
      by Janssen in South Africa, and the availability of a limited amount of vaccine doses,
      provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine
      rollout.

      Study participants Health Care workers age 18 and above working in the South African public
      and private health care sector (N=500 000) 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 single dose of vaccine at enrolment; to monitor
      outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years
      post-vaccination.

      A sub-cohort (approx. 850-1000 people) consisting of special sub-populations will be followed
      up at approx. 1, 3, 6 weeks and 6 months post vaccination. This group will also have outcomes
      monitored for up to a further 18 months, bringing their total follow-up duration to 2 years
      post-vaccination

      Study products Ad26.COV2.S by Janssen administered as a single injection

      Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID,
      hospitalizations and deaths in HCWs as compared with the general unvaccinated population in
      South Africa.

      Secondary objectives • To estimate the incidence of symptomatic SARS CoV-2 infections in HCW

        -  To estimate vaccine uptake among HCWs in South Africa

        -  To monitor the genetic diversity of breakthrough SARS CoV-2 infections To monitor
           immunological responses (neutralising, non-neutralising antibodies and T cell responses)
           in HCWs with breakthrough infections

        -  To measure baseline SARS CoV-2 antibody testing to evaluate pre-existing immunity in up
           to 100 000 HCWs.

        -  In a subgroup of participants (approx. 850-1000 people) including representative
           sub-populations of interest, e.g. elderly, immune compromised:

             -  To compare serum neutralization and immune responses before and after vaccination
                at 0, 6 weeks and up to 6 months.

             -  To explore clotting parameters post vaccination at weeks 0, 1, 3.

             -  To monitor for asymptomatic infection

      Exploratory objectives To set up a comprehensive safety desk and establish a link between the
      national pharmacovigilance system to assist with monitoring safety and any unexpected adverse
      effects
    

Intervention name(s): To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine
Intervention type(s): Biological
Intervention description(s): To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm phase 3B vaccine implementation study
Masking: None (Open Label)
Primary purpose: Prevention