Clinical trial NCT04142983: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tetanus
Lead sponsor: GCAM Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 110
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: PREVENTION

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.


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

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: Eagle Pass
country: United States
facility: GCAM Eagle Pass Center
state: Texas
city: Laredo
country: United States
facility: GCAM Laredo Center
state: Texas
Study officials:
References: