NCT04142983

Tdap Vaccine Safety for Plasma Donors

A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: GCAM Inc. · Industry
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Adacel	0.5 mL, Intramuscular

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-11-03
• Completion: 2021-11-16
• First posted: 2019-10-29
• Last updated: 2022-12-06
• Results posted: 2022-12-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study