Tdap Vaccine Safety Study for Plasma Donors

Overseen By Human Resources Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ABO Holdings, Inc.

Disqualifiers: Pregnancy, Guillain-Barré Syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the Tdap Vaccine Safety Study?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the Tdap treatment for plasma donors?

The Tdap vaccine, which protects against tetanus, diphtheria, and pertussis (whooping cough), has been shown to be effective in adolescents and adults, as seen in studies assessing its use as a booster and its effectiveness in preventing pertussis. ^{1 2 3 4 5}

Is the Tdap vaccine safe for plasma donors?

The Tdap vaccine is generally considered safe, with common mild side effects like pain, swelling, and fever. Studies in pregnant women and the elderly have not shown any unexpected or serious adverse events, and all reported side effects resolved without lasting issues. ^{6 7 8 9 10}

How does the Tdap vaccine differ from other treatments for plasma donors?

The Tdap vaccine is unique because it combines protection against three diseases: tetanus, diphtheria, and pertussis (whooping cough) in a single shot, which is not typical for plasma donors. It is primarily used to boost immunity in adults and adolescents, and its safety has been studied in various populations, including pregnant women and the elderly. ^{6 10 11 12 13}

Research Team

Adam Thaler, DO

Principal Investigator

Center Medical Director

Eligibility Criteria

Healthy adults aged 18-63 who can donate plasma and haven't had a Tdap vaccine in the last 90 days. Women must use effective birth control during the study. Participants cannot be pregnant, have severe reactions to vaccines, or conditions that could affect safety or data quality.

Inclusion Criteria

Subject is not participating in any other immunization program

Met all of the criteria required to be a Normal Source Plasma donor

I am between 18 and 63 years old.

Exclusion Criteria

Subject has repeated reactions or hypersensitivity to components in the vaccine

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

The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Tdap vaccinations every 3 months for 12 months, with plasma samples collected monthly for antibody titers

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the last vaccination, with assessments at 1 and 6 months post-treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• Tdap

Trial Overview The trial tests the safety of giving Tdap vaccinations multiple times over a year to plasma donors. It involves receiving five Tdap shots every three months and monitoring for side effects and tetanus antibody levels.

Participant Groups

Group I: Tdap for Plasma Donors Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

ABO Holdings, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

In a study of 201 pregnant women vaccinated with the Tdap vaccine, 23.9% experienced at least one adverse event following immunization, with common symptoms including pain (22.4%) and swelling (2.5%).

All reported adverse events were expected and consistent with the vaccine's package insert, with no serious or unexpected events, indicating that the Tdap vaccine is safe for use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. Gattás, VL., Luna, EJA., Sato, APS., et al.[2021]

The Tdap vaccines, ADACEL and BOOSTRIX, are recommended for adults and adolescents to protect against pertussis, but there is insufficient evidence regarding their safety for pregnant women and their fetuses.

The CDC recommends that pregnant women who have not previously received Tdap should get vaccinated in the immediate postpartum period, while also considering the timing of Td vaccinations to ensure protection against tetanus and diphtheria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). Murphy, TV., Slade, BA., Broder, KR., et al.[2022]

References

1. Kenya pubmed.ncbi.nlm.nih.gov

Immunity to tetanus in male adults in Dar es Salaam, Tanzania. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Selection of plasma donors suitable for tetanus boosting. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of pertussis vaccines for adolescents and adults: case-control study. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial. [2020]

6. Brazil pubmed.ncbi.nlm.nih.gov

Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

U.S. Postlicensure safety surveillance for adolescent and adult tetanus, diphtheria and acellular pertussis vaccines: 2005-2007. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly population. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Retrospective Cohort Study of Safety Outcomes in New Zealand Infants Exposed to Tdap Vaccine in Utero. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A phase-I, open label clinical trial to assess the safety of Tdap vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults. [2022]