Tdap Vaccine Safety for Plasma Donors

GCAM Inc.

Status and phase: Completed; Phase 3; Phase 2

Conditions: Tetanus

Treatments: Biological: Adacel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04142983

GCAM-TET-01

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 63 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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 (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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Study Group

Experimental group

Description:

Participants will receive a single dose of Tdap vaccine (Adacel) every 3 months for a total of 5 immunizations over a period of 12 months.

Treatment:

Biological: Adacel