Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36

NCT04424693 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: PE-Tdap01
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. 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 than 50%. A prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.

Conditions

Pre-Eclampsia; Diphtheria, Tetanus and Pertussis Vaccine Reaction

Keywords

Preeclampsia; Tdap vaccinations

Outcome Measures

Primary Outcomes (2)

• Incidence of preeclampsia in each arm of the study with regards to timing of Tdap vaccination

  The definition of preeclampsia in this study will follow the guidelines of ACOG inclusive of hypertension, proteinuria, but also other features

  Through duration of pregnancy approximately 10 months

• Incidence of preeclampsia in each arm of the study with regards to the quantitative anti-tetanus toxoid antibody level

  Test the hypothesis that pregnant women with anti-tetanus toxoid antibody levels \<1.0 IU/ml are at higher risk of preeclampsia compared to those with higher levels. Obtain blood levels for anti-tetanus toxoid antibody levels, anti-pertussis antibody levels, and anti-diptheria antibody levels will be tested at weeks 12, 20, and 36

  Through duration of pregnancy approximately 10 months

Secondary Outcomes (1)

• Assessment of other potential risk factors for preeclampsia inclusive of BMI, hypertension, prior history of preeclampsia, first pregnancy

  Through duration of pregnancy approximately 10 months

Other Outcomes (2)

• Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia

  Through duration of pregnancy at 12, 20 and 36 week of gestation

• Compare the placental and maternal biomarkers of preeclampsia in order to devise a better formula for positive prediction of preeclampsia

  Through duration of pregnancy at 12, 20 and 36 week of gestation

Study Arms (2)

Tdap vaccinations at gestational week 28

ACTIVE COMPARATOR

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

Drug: Tdap Vaccine Administration

Tdap vaccinations at gestational week 36

ACTIVE COMPARATOR

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

Drug: Tdap Vaccine Administration

Interventions

Tdap Vaccine Administration DRUG

Tdap vaccinations are routinely given during pregnancy between weeks 27 and 36 per guidelines of American College Obstetrics and Gynecology (ACOG) -- but this study uniquely is trying to establish that the earlier Tdap vaccinations reduce preeclampsia by more than 50%

Tdap vaccinations at gestational week 28; Tdap vaccinations at gestational week 36

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• confirmed pregnancy at week 12
• Age 18 to 42
• Willing to participate and sign informed consent documentation
• willing to follow study procedures with regards to randomization of Tdap and attend all routine clinic visits per obstetrician and standard of care
• accept Tdap vaccination either at week 28 or week 36

You may not qualify if:

• no history of allergic reaction or intolerance to Tdap vaccination
• No history of cancer in past 5 years prior to this study (except for non melanoma localized skin cancers or cancer in situ) -

Sponsors & Collaborators

• Institute of Arthritis Research: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Brigham Young University: collaborator

Study Sites (1)

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Diphtheria; Tetanus

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Study Officials

• Craig D Scoville, MD, PhD

  Institute of Arthritis Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig D Scoville, MD,PhD

CONTACT

208-542-9080; cdscoville@yahoo.com

Maritza Rosales

CONTACT

208-542-9080; maritza@scovilleclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each study site will designate an "injection nurse" who will be responsible for preparing both placebo and Tdap administration and will be the only one knowing when a patient gets either Tdap injection at week 28 or placebo injection at week 28, or gets Tdap injection at week 36 or placebo injection at week 36. This person will be the only one at each site who will know the randomization of each subject and is the only one who will administer the injection. Every subject will receive Tdap either at week 28 or week 36 and receive placebo injection on the other injection time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pregnant women enlisted in the double blinded study will be randomized to receive Tdap vaccination either at week 28 or week 36 and observed and treated with standard of care.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2024
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: see Plan Description and no time limit once the data is made available to the public
• Access Criteria: contact Institute of Arthritis Research at scovilleclinic.com

Locations

US (1)