Phase 3
N=110
Tdap Vaccine Safety for Plasma Donors
Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT04142983 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 71; 42; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adacel (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GCAM Inc.
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
71; 42; 0 | — |
| SECONDARY Anti-tetanus Antibody Titers in Participants Over Time |
1.2; 13.2; 8.1; 5.6; 9.0; 5.9 | — |
| SECONDARY Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels |
88; 8; 4; 0; 4; 22 | — |
Summary
This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.
Eligibility Criteria
Inclusion Criteria
- Male or female ages 18 to 63 years
- Females of childbearing potential who agree to employ adequate birth control measures during the study
- Signed the informed consent form (ICF)
- Met all of the criteria required by GCAM to be a Normal Source Plasma donor
- Subject is not participating in any other immunization program
Exclusion Criteria
- Subject is pregnant
- Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
- Subject has repeated reactions or hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
- Subject has history of a severe reaction to any immunization
- Subject has a history of Guillain-Barré Syndrome
- The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment
Data sourced from ClinicalTrials.gov (NCT04142983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.