Tdap Vaccine Safety for Plasma Donors

NCT04142983 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GCAM-TET-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Tetanus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anti-tetanus Antibody Titers in Participants 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

  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

Study Arms (1)

Study Group

EXPERIMENTAL

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

Interventions

Adacel BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Tdap Vaccine

Study Group

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCAM Inc.: lead

Study Sites (2)

GCAM Eagle Pass Center

Eagle Pass, Texas, 78852, United States

Location

GCAM Laredo Center

Laredo, Texas, 78040, United States

Location

MeSH Terms

Conditions

Tetanus

Interventions

adacel

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Center Medical Director
• Organization: GCAM / Biomat USA - Grifols

laredomedical@gcamplasma.com

956-729-7677

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: February 3, 2020
• Primary Completion: November 3, 2021
• Study Completion: November 16, 2021
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)