Clinical trial NCT05662852: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Tetanus, Diphtheria and Acellular Pertussis Vaccination
Keywords: Plasma
Plasma Donor
Plasma Donation
Hyperimmunization
Tetanus
Immunoglobulin
Lead sponsor: ABO Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Anti-tetanus Antibody Titers in Participants Over Time
timeFrame: 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
measure: Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
timeFrame: 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
Other outcomes:
Locations:
city: Glassboro
country: United States
facility: ABO Plasma
state: New Jersey
Study officials:
affiliation: Center Medical Director
name: Adam Thaler, DO
role: PRINCIPAL_INVESTIGATOR
References: