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Tdap Vaccine Safety for Plasma Donors

Sponsor
GCAM Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04142983
Collaborator
(none)
100
Enrollment
2
Locations
1
Arm
21.4
Actual Duration (Months)
50
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Adacel
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine
Actual Study Start Date :
Feb 3, 2020
Actual Primary Completion Date :
Nov 3, 2021
Actual Study Completion Date :
Nov 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

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.

Biological: Adacel
0.5 mL, Intramuscular
Other Names:
  • Tdap Vaccine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AEs occurring after each vaccination up to the time of the next vaccination and separately over the whole study period [18 months]

      Safety

    Secondary Outcome Measures

    1. Maximum concentrations of Tetanus antibody titers after each vaccination at all study collection time points [18 months]

      Efficacy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 63 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GCAM Eagle Pass Center Eagle Pass Texas United States 78852
    2 GCAM Laredo Center Laredo Texas United States 78040

    Sponsors and Collaborators

    • GCAM Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GCAM Inc.
    ClinicalTrials.gov Identifier:
    NCT04142983
    Other Study ID Numbers:
    • GCAM-TET-01
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tetanus
    Vaccines

    Study Results

    No Results Posted as of Dec 16, 2021