Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

NCT ID: NCT05662852

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2025-05-12

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tdap for Plasma Donors

Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year.

Group Type: EXPERIMENTAL

Tdap

Intervention Type: BIOLOGICAL

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension manufactured by Sanofi Pasteur

Interventions

Tdap

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension manufactured by Sanofi Pasteur

Intervention Type: BIOLOGICAL

Other Intervention Names

Adacel

Eligibility Criteria

Inclusion Criteria

• Male or female ages 18 to 63 years
• Females of childbearing potential who agree to employ highly effective birth control measures during the study
• Signed the informed consent form (ICF)
• Met all of the criteria required to be a Normal Source Plasma donor
• Subject is not participating in any other immunization program
• Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ABO Holdings, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Thaler, DO

Role: PRINCIPAL_INVESTIGATOR

Center Medical Director

Locations

ABO Plasma

Glassboro, New Jersey, United States

Countries

United States

Other Identifiers

ABO-TET-01

Identifier Type: -

Identifier Source: org_study_id