Skip to main content
OpenTrials
Completed

NCT Number: NCT04142983

Tdap Vaccine Safety for Plasma Donors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

GCAM Eagle Pass Center, Eagle Pass, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adacel

Biological

0.5 mL, Intramuscular

Other names: Tdap Vaccine

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 18 months

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as an adverse event occurring after first study treatment. A serious TEAE was defined as an AE that resulted in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, an important medical event that based on appropriate medical judgment may jeopardize the subject and may require medical or surgical intervention to prevent one of the aforementioned outcomes.

Secondary outcomes

  1. Anti-tetanus Antibody Titers in Participants Over Time

    Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18

    Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.

  2. Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels

    Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18

    The numbers and percentages of participants whose post vaccination antibody levels were <5 IU/mL; ≥5 IU/mL to 10 IU/mL; >10 IU/mL to 15 IU/mL; and, >15 IU/mL after each vaccination.

Sponsors and collaborators

Lead sponsor

GCAM Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2019
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.