Tdap Vaccine Safety for Plasma Donors

Brief Title

Tdap Vaccine Safety for Plasma Donors

Official Title

A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine

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.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

AEs occurring after each vaccination up to the time of the next vaccination and separately over the whole study period

Secondary Outcome

 Maximum concentrations of Tetanus antibody titers after each vaccination at all study collection time points

Condition

Tetanus

Intervention

Adacel

Study Arms / Comparison Groups

 Study 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

100

Start Date

February 3, 2020

Completion Date

December 2021

Primary Completion Date

November 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 63 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04142983

Organization ID

GCAM-TET-01


Responsible Party

Sponsor

Study Sponsor

GCAM Inc.


Study Sponsor

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Verification Date

May 2020