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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

Study Record Versions

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12026-04-18Current
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Viewing V1 (2026-04-18)

Study Details

Study Identification

Unique Protocol IDBMU-MED-2026-001
Brief TitleImmunogenicity of a COVID-19 Booster Vaccine in Older Adults (BOOST-IMM)
Official TitleA Randomised Study of the Immunogenicity and Safety of a COVID-19 Booster Vaccine in Older Adults
Secondary IDs

Study Status

Record Verification2026-04
Overall StatusTerminated
Study Start2025-06-01
Primary Completion2025-12-31
Study Completion2026-02-28
First Submitted
First Submitted that Met QC Criteria2025-05-24
First Posted2025-05-24 [Actual]
Last Update Submitted that Met QC Criteria2026-04-18
Last Update Posted2026-04-18 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringYes

Study Description

Brief SummaryThis 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 DescriptionOlder 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.

Conditions

ConditionCOVID-19 Immunisation
KeywordsCOVID-19 vaccine booster immunogenicity

Study Design

Study TypeInterventional
Primary PurposePrevention
Study Phase
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingDouble blind
AllocationRandomized
Enrollment150 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: Booster vaccineBiological/Vaccine: COVID-19 booster vaccine
Placebo Comparator: PlaceboOther: Placebo

Outcome Measures

Primary Outcome MeasuresGeometric mean antibody titre Time Frame: 28 days post-vaccination
Secondary Outcome MeasuresRate of solicited adverse events Time Frame: 7 days post-vaccination

Eligibility

Minimum Age60 Years
Maximum Age
Ages60 Years and older (Adult, Older Adult)
SexAll
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersYes
Criteria<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>

Contacts/Locations

Central Contact PersonRegistry Coordinator boost-imm@bmu.ac.bd
Study Officials
LocationDhaka, Dhaka, Bangladesh, 1000 Status: Terminated Facility: Bangladesh Medical University, Clinical Research Centre

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents