Tdap Vaccine Safety for Plasma Donors

Study Overview
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Brief Summary
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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.

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

Conditions
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Tetanus

Intervention / Treatment
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* Biological: Adacel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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<br>* 0.5 mL, Intramuscular<br>* Other names: Tdap Vaccine;|

What is the study measuring?
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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 |