NCT05662852

Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: ABO Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are: * Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years? * What is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study? Participants will receive a Tdap vaccination every 3 months ±2 weeks 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, Diphtheria and Acellular Pertussis Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Tdap	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension manufactured by Sanofi Pasteur

Timeline

• Start date: 2023-05-05
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2022-12-23
• Last updated: 2025-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study