Tdap Vaccine Safety for Plasma Donors

Completed · Phase 2/Phase 3

Conditions studied: Tetanus

In brief

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.

Key facts

Study ID

NCT04142983

Run by

GCAM Inc.

People needed

110

Starts

2020-02-03

Expected to finish

2021-11-16

Last updated by the study team

2022-12-06

Who can join

Age: 18 and older, up to 63. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GCAM Eagle Pass Center — Eagle Pass, Texas, United States
• GCAM Laredo Center — Laredo, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.