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Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

Primary Purpose

Tetanus, Diphtheria and Acellular Pertussis Vaccination

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tdap
Sponsored by
ABO Holdings, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tetanus, Diphtheria and Acellular Pertussis Vaccination focused on measuring Plasma, Plasma Donor, Plasma Donation, Hyperimmunization, Tetanus, Immunoglobulin

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female ages 18 to 63 years Females of childbearing potential who agree to employ highly effective birth control measures during the study Signed the informed consent form (ICF) Met all of the criteria required to be a Normal Source Plasma donor Subject is not participating in any other immunization program Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination 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 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

  • ABO Plasma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tdap for Plasma Donors

Arm Description

Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year.

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

First Posted
December 15, 2022
Last Updated
May 1, 2023
Sponsor
ABO Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05662852
Brief Title
Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors
Official Title
A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine for a Hyperimmunization Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ABO Holdings, 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
The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are: Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years? What is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study? Participants will receive a Tdap vaccination every 3 months ±2 weeks 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, Diphtheria and Acellular Pertussis Vaccination
Keywords
Plasma, Plasma Donor, Plasma Donation, Hyperimmunization, Tetanus, Immunoglobulin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tdap for Plasma Donors
Arm Type
Experimental
Arm Description
Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year.
Intervention Type
Biological
Intervention Name(s)
Tdap
Other Intervention Name(s)
Adacel
Intervention Description
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension manufactured by Sanofi Pasteur
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 highly effective birth control measures during the study Signed the informed consent form (ICF) Met all of the criteria required to be a Normal Source Plasma donor Subject is not participating in any other immunization program Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Thaler, DO
Organizational Affiliation
Center Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABO Plasma
City
Glassboro
State/Province
New Jersey
ZIP/Postal Code
08028
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

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