Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

Last updated: June 24, 2025
Sponsor: ABO Holdings, Inc.
Overall Status: Completed

Phase

2

Condition

Throat And Tonsil Infections

Treatment

Tdap

Clinical Study ID

NCT05662852
ABO-TET-01
  • Ages 18-63
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ages 18 to 63 years

  • Females of childbearing potential who agree to employ highly effective birth controlmeasures 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 studyvaccination

Exclusion

Exclusion Criteria:

  • Subject is pregnant

  • Subject has a condition or abnormality that in the opinion of the Investigator wouldcompromise 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) isnot suitable for AE assessment

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Tdap
Phase: 2
Study Start date:
May 05, 2023
Estimated Completion Date:
May 12, 2025

Connect with a study center

  • ABO Plasma

    Glassboro, New Jersey 08028
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.