TDAP Safety in Pregnant Women

NCT02209623 | Completed

• 1 other identifier: CISA 2014 Task III
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited. Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant. Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.

Conditions

Pertussis

Outcome Measures

Primary Outcomes (2)

• Rates of injection-site and systemic reactions post Tdap administration.

  Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.

  7 days post administration

• Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally

  Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.

  7 days post delivery

Secondary Outcomes (3)

• Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose

  7 days post vaccination

• Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap

  7 days post delivery

• Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy

  6 months post delivery

Other Outcomes (2)

• Measurement of serum cytokines before and after severe, local and systemic reactions

  28 days post vaccination

• Measurement of serum antibody levels to pertussis toxin, filamentous hemagglutinin, pertactin, fimbria and diphtheria and tetanus toxins

  28 days post vaccination

Study Arms (1)

Pregnant Women receiving TDAP

Biological: TDAP

Interventions

TDAP BIOLOGICAL

Pregnant Women receiving TDAP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

375 healthy pregnant women at ≥ 20 weeks 0 days gestation through ≤ 34 weeks 0 days gestation and their infants and 225 healthy non-pregnant women, age range 18-45 years

You may qualify if:

• Subjects who meet the following criteria will be eligible to participate in this observational study. Tdap administration will be given as routine standard of care.
• Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years of age inclusive
• For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks 0 days gestation based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
• Intention of receiving Tdap vaccine based on ACIP guidelines
• Willing to provide written informed consent prior to initiation of any study procedures
• English or Spanish literate
• Intention of being available for entire study period and complete all relevant study procedures

You may not qualify if:

• Subjects who meet the following criteria will not be eligible to participate in this study:
• Febrile illness within the last 24 hours or an oral temperature \> 100.4oF (\> 38oC) prior to Tdap administration
• Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine
• Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
• Known or suspected impairment of immunologic function including active infection with HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.
• Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung maturity within 8 days post enrollment, she would not be excluded from the study for reactogenicity analysis. However, if antenatal corticosteroids were received anytime between vaccination and 28-day sample collection for serologic studies, she would be excluded from serologic studies as they could be altered by steroid receipt.
• Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap vaccination in this study or planning receipt of any vaccines during 8-day post-vaccination period.
• Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
• Anyone who is a relative of any research study personnel
• Anyone who is an employee of any research study personnel
• For pregnant women only
• Tdap/Td/TT receipt during current pregnancy prior to study enrollment
• Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change
• For non-pregnant women only
• Intention of becoming pregnant during study participation

Sponsors & Collaborators

• Vanderbilt University: lead
• Duke University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine

Durham, North Carolina, 27705, United States

Location

Vanderbilt Medical Center, Vaccine Research Program

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, Liang J, Walter EB, Heine RP, Moody MA, Yoder S, Edwards KM. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354-6360. doi: 10.1016/j.vaccine.2018.07.012. Epub 2018 Sep 13.

  PMID: 30219367 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Samples

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Kathryn M Edwards, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

• Geeta K Swamy, MD

  Duke Medical Center

  PRINCIPAL INVESTIGATOR

• Karen R Broder, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Kimberly B Fortner, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Sarah Sell and Cornelius Vanderbilt Chair of Pediatrics

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 6, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: December 18, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)