Tdap Vaccine Safety for Plasma Donors

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142983
• Other study ID #: GCAM-TET-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 3, 2020
• Est. completion date: November 16, 2021

Study information

• Verified date: November 2022
• Source: GCAM Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 16, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Tetanus

Intervention

Biological:
• Adacel
0.5 mL, Intramuscular

Locations

Country	Name	City	State
United States	GCAM Eagle Pass Center	Eagle Pass	Texas
United States	GCAM Laredo Center	Laredo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GCAM Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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