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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of administering the Tdap vaccine multiple times within one year to healthy plasma donors, rather than the usual once every ten years. Researchers aim to determine the safety of repeated vaccinations and observe how tetanus antibodies (proteins that fight infection) respond over time. Ideal participants are plasma donors who have not received a Tdap shot in the last 90 days and are not involved in other immunization programs. Participants will receive the vaccine every three months for a year and will be monitored for side effects and antibody levels. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine safety data.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the Tdap vaccine is generally safe. Studies have found that while vaccines like Tdap can cause side effects, they are usually mild. Common side effects include soreness at the injection site or a mild fever, similar to those from other vaccines.

The Tdap vaccine has a strong safety record. Approved for use in teenagers and adults, it is typically administered every 10 years. This trial tests its safety when given more frequently, specifically every three months, which is not standard.

Although this schedule is atypical, the Tdap vaccine's approval for general use indicates thorough testing and safety for most people when used as directed. This trial specifically examines any new safety information that might arise from more frequent administration to plasma donors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard vaccines that are typically administered once, the Tdap vaccine for plasma donors is given repeatedly every 90 days over the course of a year. Researchers are excited about this approach because it could enhance the safety and efficacy of plasma donation by ensuring donors maintain strong immunity against tetanus, diphtheria, and pertussis. This frequent dosing schedule could potentially offer more consistent protection, which is particularly important for plasma donors who may be exposed to different pathogens.

What evidence suggests that the Tdap vaccine is safe and effective for plasma donors?

Studies have shown that the Tdap vaccine effectively boosts protection against tetanus, diphtheria, and pertussis. Research indicates that about 73% of people maintain strong protection in the first year after vaccination, with around 34% retaining good protection four years later. The vaccine helps the body produce antibodies, proteins that combat these infections. In this trial, which focuses on safety and repeated dosing for plasma donors, the vaccine's ability to trigger a strong antibody response is well-documented. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam Thaler, DO

Principal Investigator

Center Medical Director

Are You a Good Fit for This Trial?

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 using effective birth control and can become pregnant.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8299947/

The Effect of Tetanus-Diphtheria-Acellular-Pertussis ... Infants of women immunized with Tdap in pregnancy had significantly lower anti-PT IgG levels compared with infants of women who did not receive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05662852

Safety and Immunogenicity Study of Tdap Vaccinations for ... The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. ... Pertussis Vaccine ...

3. withpower.com withpower.com/trial/phase-2-tetanus-2-2023-1326b

Tdap Vaccine Safety Study for Plasma Donors The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors.

4. cdc.gov cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/about-vaccine.html

About Diphtheria, Tetanus, and Pertussis Vaccination About 73% of adolescents in the first year after vaccination; About 34% of people 4 years after vaccination. In studies demonstrating the efficacy of the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590136221000048

Effect of maternal Tdap on infant antibody response to a ... This study aimed to assess the effect of Tdap vaccination during pregnancy on infant antibody response to the whole cell pertussis (DTwP) primary series.

6. cdc.gov cdc.gov/vaccine-safety/vaccines/dtap-tdap.html

Diphtheria, Tetanus, and Pertussis Vaccine Safety DTaP and Tdap vaccine are safe and effective at preventing diphtheria, tetanus, and pertussis. Vaccines, like any medicine, can have side effects.

7. chop.edu chop.edu/vaccine-education-center/vaccine-details/diphtheria-tetanus-and-pertussis-vaccines

Diphtheria, Tetanus and Pertussis: The Diseases & Vaccines Diphtheria, tetanus and pertussis are prevented by a childhood vaccine, called DTaP, and a vaccine for adolescents and adults, called Tdap.

8. mayoclinic.org mayoclinic.org/drugs-supplements/diphtheria-tetanus-and-acellular-pertussis-booster-vaccine-intramuscular-route/description/drg-20122575

Diphtheria, tetanus, and acellular pertussis booster vaccine ... Adults and teenagers should receive Tdap instead of the tetanus-diphtheria (Td) injection if it has been 10 years or more since their last ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X22007563

Safety of tetanus, diphtheria, acellular pertussis (Tdap) ... The objective of this study was to evaluate the safety of prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6476554/

Safety Surveillance of Diphtheria and Tetanus Toxoids and ... Post-marketing observational studies have shown that the DTaP-containing vaccines have a good safety record [11–22]. In two studies of DTwP and DTaP vaccines ...