Tetanus, Diphtheria and Acellular Pertussis VaccinationPhase 2NCT05662852
Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors
A Phase 2 study testing Tdap in people with Tetanus, Diphtheria and Acellular Pertussis Vaccination, run by ABO Holdings, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria and Acellular Pertussis Vaccination
- What is being tested?
- Tdap
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 12 May 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine for a Hyperimmunization Program
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.
- Being tested
- Tdap
- Keywords
- Plasma, Plasma Donor, Plasma Donation, Hyperimmunization, Tetanus, Immunoglobulin
- Medical subject headings
- Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TdapBiological
Also called Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Suspension manufactured by Sanofi Pasteur
| Study group | Role | What they receive |
|---|---|---|
| Tdap for Plasma Donors | Experimental | Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year. Receives: Biological: Tdap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Secondary outcomes (2)
Anti-tetanus Antibody Titers in Participants Over Time
Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start5 May 2023
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tetanus, Diphtheria and Acellular Pertussis VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABO Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Thaler, DO, Principal investigator, Center Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662852
- Sponsor's protocol ID
- ABO-TET-01
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No