Tdap Vaccine Safety for Plasma Donors
Primary Purpose
Tetanus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adacel
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus
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
Sites / Locations
- GCAM Eagle Pass Center
- GCAM Laredo Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Anti-tetanus Antibody Titers in Participants Over Time
Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04142983
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCAM Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Adacel
Other Intervention Name(s)
Tdap Vaccine
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Anti-tetanus Antibody Titers in Participants Over Time
Description
Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) 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
Title
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
GCAM Eagle Pass Center
City
Eagle Pass
State/Province
Texas
ZIP/Postal Code
78852
Country
United States
Facility Name
GCAM Laredo Center
City
Laredo
State/Province
Texas
ZIP/Postal Code
78040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tdap Vaccine Safety for Plasma Donors
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