Tdap Vaccine Safety for Plasma Donors

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

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 Overview

• Status: Completed
• Conditions: Tetanus
• Intervention / Treatment: Biological: Adacel

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Eagle Pass, Texas, United States, 78852
      • GCAM Eagle Pass Center
    • Laredo, Texas, United States, 78040
      • GCAM Laredo Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-tetanus Antibody Titers in Participants Over Time	Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.	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
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels	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.	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

Collaborators and Investigators

• Sponsor: GCAM Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Tetanus; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GCAM-TET-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No