deltatrials
Unknown PHASE3 INTERVENTIONAL NCT05148845

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

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)

Sponsor: Bio Analytical Research Corporation

Interventions Booster vaccine
Updated 7 times since 2022 Last updated: Jul 29, 2022 Started: Nov 10, 2021 Primary completion: Jan 31, 2022 Completion: Jun 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05148845, this PHASE3 trial focuses on SARS CoV 2 Infection and remains ongoing. Sponsored by Bio Analytical Research Corporation, it has been updated 7 times since 2021, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2022 – ~May 2022 · 4 months · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Jan 2024 · 16 months · monthly snapshotRecruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 11 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  4. Jan 2024 — Jul 2024 [monthly]

    Unknown Status PHASE3

    Status: RecruitingUnknown Status

  5. Sep 2022 — Jan 2024 [monthly]

    Recruiting PHASE3

Show 2 earlier versions
  1. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  2. Jan 2022 — May 2022 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

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

For direct contact, visit the study record on ClinicalTrials.gov .