NCT04838795: Sisonke

Sisonke (Together): OPEN LABEL TRIAL COVID-19

Completed Phase 3 Last updated 1 August 2022

What this trial tests

Phase 3 trial testing To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine in SARS (Severe Acute Respiratory Syndrome) in 477,102 participants. Completed in 31 March 2022.

Timeline

17 February 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Wits Health Consortium (Pty) Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	477,102
Start date	17 February 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	31 locations across South Africa

Drugs / interventions tested

• To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine — full drug profile →

Conditions studied

• SARS (Severe Acute Respiratory Syndrome) — all drugs for SARS (Severe Acute Respiratory Syndrome) →

Sponsor

Wits Health Consortium (Pty) Ltd

Who can join

Adults 18 to 105, any sex, with SARS (Severe Acute Respiratory Syndrome). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral vector-based gene therapies in the clinic.
   Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
2. COVID-19 vaccine access in Africa: Global distribution, vaccine platforms, and challenges ahead.
   Massinga Loembé M, Nkengasong JN. · · 2021 · cited 76× · PMID 34260880 · DOI 10.1016/j.immuni.2021.06.017
3. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study.
   Bekker LG, Garrett N, Goga A, Fairall L, et al · · 2022 · cited 63× · PMID 35305740 · DOI 10.1016/s0140-6736(22)00007-1
4. Adenoviral Vector-Based Vaccine Platform for COVID-19: Current Status.
   Chavda VP, Bezbaruah R, Valu D, Patel B, et al · · 2023 · cited 49× · PMID 36851309 · DOI 10.3390/vaccines11020432
5. Delivery Routes for COVID-19 Vaccines.
   Park JH, Lee HK. · · 2021 · cited 48× · PMID 34069359 · DOI 10.3390/vaccines9050524
6. Vaccines for COVID-19: A Systematic Review of Immunogenicity, Current Development, and Future Prospects.
   Zhang Z, Shen Q, Chang H. · · 2022 · cited 44× · PMID 35572592 · DOI 10.3389/fimmu.2022.843928
7. Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Ad26.CoV2.S Vaccination in People Living With Human Immunodeficiency Virus (HIV).
   Khan K, Lustig G, Bernstein M, Archary D, et al · · 2022 · cited 41× · PMID 34893824 · DOI 10.1093/cid/ciab1008
8. Breakthrough SARS-CoV-2 infections during periods of delta and omicron predominance, South Africa.
   Goga A, Bekker LG, Garrett N, Reddy T, et al · · 2022 · cited 37× · PMID 35809579 · DOI 10.1016/s0140-6736(22)01190-4