Tdap Vaccination Timing for Preeclampsia

Overseen By Maritza Rosales

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Institute of Arthritis Research

Disqualifiers: Cancer, Tdap allergy, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering the Tdap vaccine (Tetanus, Diphtheria, and Pertussis Vaccine) earlier in pregnancy can reduce the risk of preeclampsia, a serious condition affecting some pregnant women that can harm both mother and baby. Participants will receive the vaccine at either 28 weeks or 36 weeks of pregnancy to determine if timing affects outcomes. Women who are 12 weeks pregnant and willing to follow the trial procedures are suitable candidates for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective vaccine can benefit more patients.

Do I have to stop taking my current medications for the trial?

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

What is the safety track record for the Tdap Vaccine?

Research shows that receiving the Tdap vaccine during pregnancy is safe. The Centers for Disease Control and Prevention (CDC) and other health organizations recommend vaccination between the 27th and 36th weeks of pregnancy. This timing provides the most benefits for both mother and baby.

Studies have found that the Tdap vaccine is generally well-tolerated, with most people experiencing only mild side effects, such as soreness at the injection site. Serious reactions are rare. The vaccine protects newborns from whooping cough, which can be very dangerous for them.

In this trial, participants will receive the vaccine either at week 28 or week 36, following these guidelines. The vaccine is already FDA-approved for use in pregnant women, supporting its safety. This trial aims to determine the best timing for the vaccine to potentially reduce the risk of preeclampsia, a serious pregnancy complication. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the timing of Tdap vaccination during pregnancy to potentially impact the development of preeclampsia. Unlike the standard care options for preeclampsia, which typically involve blood pressure management and monitoring, this trial investigates whether the timing of Tdap vaccination can play a role in preventing or reducing the severity of the condition. By evaluating the effects of administering the vaccine at either week 28 or week 36 of pregnancy, scientists aim to uncover whether the timing influences maternal and fetal health outcomes. This approach could lead to a novel preventative strategy for managing preeclampsia, offering new insights into maternal healthcare.

What evidence suggests that early Tdap vaccination might be an effective treatment for preeclampsia?

This trial will compare the timing of Tdap vaccination at gestational week 28 versus week 36 to assess its impact on preeclampsia. Research has shown that receiving the Tdap vaccine early in pregnancy can significantly lower the risk of preeclampsia, a serious condition for pregnant women. Dr. Craig D. Scoville's findings suggest it can reduce the risk by more than half. Although the Tdap vaccine is typically given to prevent whooping cough, it may also benefit the mother's health when administered between 27 and 36 weeks of pregnancy. While the vaccine primarily protects babies from whooping cough, these findings indicate it could also aid mothers. This trial will specifically evaluate the effects of administering the vaccine at both 28 and 36 weeks, focusing on its potential to significantly reduce the risk of preeclampsia. ^{1 2 6 7 8}

Who Is on the Research Team?

Craig D Scoville, MD, PhD

Principal Investigator

Institute of Arthritis Research

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-42, confirmed at week 12, who are willing to get the Tdap vaccine at either week 28 or week 36 and follow study procedures. They must sign informed consent and have no history of allergic reactions to Tdap or cancer (except certain skin cancers) in the past five years.

Inclusion Criteria

I am willing to get the Tdap vaccine at week 28 or 36.

Confirmed pregnancy at week 12

Willing to participate and sign informed consent documentation

Exclusion Criteria

No history of allergic reaction or intolerance to Tdap vaccination

I haven't had any cancer except for non-dangerous skin cancer or localized cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Baseline

Participants are randomized to receive Tdap vaccination at either week 28 or week 36 and baseline data is collected

12 weeks

1 visit (in-person)

Treatment

Participants receive Tdap vaccination at either week 28 or week 36, with placebo given at the alternate week

8 weeks

3 visits (in-person) at weeks 28, 36, and 2 weeks postpartum

Follow-up

Participants are monitored for the development of preeclampsia and fetal health outcomes

10 months

Routine clinic visits throughout pregnancy

What Are the Treatments Tested in This Trial?

Interventions

• Tdap Vaccine

Trial Overview The study is testing if getting a Tdap vaccination earlier in pregnancy (week 28) versus later (week 36) can reduce the risk of developing preeclampsia, which affects maternal and fetal health.

How Is the Trial Designed?

Group I: Tdap vaccinations at gestational week 36 Active Control 1 Intervention

Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 36 will receive a placebo injection at week 28. Subjects will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health

Group II: Tdap vaccinations at gestational week 28 Active Control 1 Intervention

Pregnant women entering into this clinical research study and signing informed consent at week 12 will be randomized to either receive Tdap vaccination at week 28 or week 36. Subjects receiving Tdap vaccination at week 28 will receive a placebo injection at week 36. Subject will be followed with routine standard of care throughout their pregnancy and have routine clinic visits from which study visits will include weeks 12, 20, 28, 36, and 2 weeks postpartum. Data will be collected at each of these visits with special attention to the development of preeclampsia and fetal health

Tdap Vaccine is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Approved in Canada as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Approved in European Union as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Who Is Running the Clinical Trial?

Institute of Arthritis Research

Lead Sponsor

Trials

1

Recruited

1,600+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Brigham Young University

Collaborator

Trials

23

Recruited

10,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04424693

NCT04424693 | Comparing the Incidence of Preeclampsia ... An important discovery has been made by Dr Craig D Scoville showing that early Tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6599584/

Evaluation of the Association of Maternal Pertussis ... In women receiving Tdap before 20 weeks' gestation, 8.2% developed a hypertensive disorder of pregnancy vs 8.0% of unexposed women (adjusted RR, 1.09; 95% CI, ...

3. cdc.gov cdc.gov/pertussis/hcp/vaccine-recommendations/vaccinating-pregnant-patients.html

Vaccinating Pregnant Patients | Whooping Cough A CDC evaluation found Tdap vaccination during the third trimester of pregnancy prevents 78% of pertussis cases in infants younger than 2 months ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9925651/

Investigating Tetanus, Diphtheria, Acellular Pertussis ... ... Tdap vaccine administration between 27 and 36 weeks' gestation is recommended, although Tdap vaccine may be given at any time during pregnancy [ ...

5. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and-pregnancy-tetanus-diphtheria-and-pertussis-vaccination

Tetanus, Diphtheria, and Pertussis Vaccination The recommended timing for maternal Tdap vaccination is between 27 weeks and 36 weeks of gestation. To maximize the maternal antibody response and passive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04424693

Comparing the Incidence of Preeclampsia Between ... Every subject will receive Tdap either at week 28 or week 36 and receive placebo injection on the other injection time. Arms and Interventions ...

7. 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6586223/

Association of Tdap Vaccination With Acute Events and ... These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.