drugset / Trial / NCT05109559
Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine
Phase 1/2
Unknown
690 enrolled
Mahidol University
International Vaccine Institute · collabJanssen Pharmaceuticals · collabNational Vaccine Institute, Thailand · collab
Non-randomizedParallel-groupSingle-blindPrevention
Summary
This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are documented to have received either 1-dose or 2-doses (primary series completion) of inactivated COVID-19 vaccines, Sinovac and/or Sinopharm.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2023-12
- Completion
- 2024-12
Publications
- Muangnoicharoen S, Wiangcharoen R, Lawpoolsri S, Nanthapisal S, Jongkaewwattana A, Duangdee C, Kamolratanakul S, Luvira V, Thanthamnu N, Chantratita N, Thitithanyanont A, Anh Wartel T, Excler JL, Ryser MF, Leong C, Mak TK, Pitisuttithum P. Heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination against SARS-CoV-2 infection: 1-year follow-up of a phase 1/2 open-label trial. Vaccine. 2024 Jul 25;42(19):3999-4010. doi: 10.1016/j.vaccine.2024.05.010. Epub 2024 May 13.
- Muangnoicharoen S, Wiangcharoen R, Nanthapisal S, Kamolratakul S, Lawpoolsri S, Jongkaewwattana A, Thitithanyanont A, Luvira V, Chinwangso P, Thanthamnu N, Chantratita N, Lim JK, Anh Wartel T, Excler JL, Ryser MF, Leong C, Mak TK, Pitisuttithum P. Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial. Vaccine. 2023 Jul 19;41(32):4648-4657. doi: 10.1016/j.vaccine.2023.06.043. Epub 2023 Jun 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.COV2.S | Vaccine | 2.5e+10 unknown | Intramuscular |
| Subject | Ad26.COV2.S | Vaccine | 5e+10 unknown | Intramuscular |