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Immunogenicity of a COVID-19 Booster Vaccine in Older Adults
- BDCTR ID
- BDCTR-2026-000039
- Sponsor
- Bangladesh Medical University
- Information provided by
- Bangladesh Medical University (Responsible Party)
- Last Update Posted
- 2026-04-18
Terminated
No longer looking for participants
Trial Contacts
| ContactsICMJE | Contact information is displayed when a study is open for participants to join. |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2025-05-24 |
| Last Update Posted | 2026-04-18 |
| Last Verified* | 2026-04 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Geometric mean antibody titre [Time Frame: 28 days post-vaccination] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Rate of solicited adverse events [Time Frame: 7 days post-vaccination] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Immunogenicity of a COVID-19 Booster Vaccine in Older Adults |
|---|---|
| Official Title*§ICMJE | A Randomised Study of the Immunogenicity and Safety of a COVID-19 Booster Vaccine in Older Adults |
| Acronym[*] | BOOST-IMM |
| Brief Summary* | This study assessed the immunogenicity and safety of a COVID-19 booster vaccine in older adults. The study was terminated early due to low enrolment. |
| Detailed Description | Older adults were randomised to the booster vaccine or placebo. Antibody responses were measured at 28 days. Enrolment was stopped early and the study was terminated. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | Not provided |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: Double blind Primary Purpose: Prevention |
| Condition*ICMJE | COVID-19 Immunisation |
| Keywords | COVID-19 vaccine booster immunogenicity |
| Intervention*ICMJE | Biological/Vaccine: COVID-19 booster vaccine Other: Placebo |
| Study Arms*ICMJE | Experimental: Booster vaccine Interventions: Biological/Vaccine: COVID-19 booster vaccine Placebo Comparator: Placebo Interventions: Other: Placebo |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Terminated |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 150 |
| Study Start Date*§ICMJE | 2025-06-01 |
| Primary Completion Date* | 2025-12-31 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2026-02-28 |
| Eligibility Criteria*ICMJE | <p>Inclusion Criteria:</p><ul><li>Adults aged 60 years and older.</li><li>Completed a primary COVID-19 vaccination series.</li></ul><p>Exclusion Criteria:</p><ul><li>Known allergy to a vaccine component.</li></ul> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: All |
| Ages*ICMJE | 60 Years and older (Adult, Older Adult) |
| Accepts Healthy Volunteers*§ICMJE | Yes |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000039 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-MED-2026-001 |
| Has Data Monitoring Committee | Yes |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Bangladesh Medical University |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | icddr,b |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
- *
- Required
- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
- Unmarked fields are optional. If no information is provided, fields will be labeled as “Not provided”.
- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP