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Observational Maternal COVID-19 Vaccination Study

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ClinicalTrials.gov Identifier: NCT04826640
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : May 27, 2021
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Information provided by (Responsible Party):
Duke University

Brief Summary:

This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 8 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference.

Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible.

Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.


Condition or disease Intervention/treatment
Pregnancy Other: Observational

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Pregnant Women
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Group/Cohort Intervention/treatment
Pregnant women who receive COVID-19 vaccine
Pregnant women who receive COVID-19 vaccine
Other: Observational
Observational




Primary Outcome Measures :
  1. Adverse birth outcomes in pregnant women vaccinated with COVID-19 vaccine [ Time Frame: 12 months ]

    As measured by the proportion of women experiencing one of the following:

    Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.



Secondary Outcome Measures :
  1. Preterm birth after COVID-19 vaccination [ Time Frame: 12 months ]
    As measured by proportions of preterm birth after COVID-19 vaccination

  2. Combined fetal and neonatal death after COVID-19 vaccination [ Time Frame: 12 months ]
    As measured by proportions of combined fetal and neonatal death after COVID-19 vaccination

  3. Spontaneous abortion after COVID-19 vaccination [ Time Frame: 12 months ]
    As measured by proportions of spontaneous abortion after COVID-19 vaccination

  4. Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination [ Time Frame: 7 days ]
    As measured by proportions of pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination

  5. Women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination [ Time Frame: 3 months ]
    As measured by proportion of women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
350 adult pregnant women aged 18-45 years at < 34 weeks gestation who plan on receiving COVID-19 vaccination during the current pregnancy in accordance with the Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians & Gynecologists (ACOG) national recommendations.
Criteria

Inclusion Criteria:

  1. Pregnant women 18-45 years of age at the time of consent, inclusive
  2. Intention of receiving or within 3 days of receiving the first dose or only dose of COVID-19 vaccine based on Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) guidelines in response to the FDA Emergency Use Authorization (EUA) and in conjunction with federal and local vaccination campaign distribution plans
  3. Willing to provide informed consent in a written or electronic format
  4. Gestational age at time of consent < 34 weeks 0 days 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 "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.
  5. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.
  6. English or Spanish literate

Exclusion Criteria:

  1. Has immunosuppression as a result of an underlying illness. Stable hepatitis B, hepatitis C, or HIV are permitted per the following parameters

    1. If known hepatitis C (HCV): evidence of sustained virological response for > or + 12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
    2. If known hepatitis B (HBV): confirmed inactive chronic HBV infection: HBsAg present for > or = 6 months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL; persistently normal alanine transaminase (ALT) and/or aspartate transaminase (AST) levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation
    3. If known HIV infection: confirmed stable HIV disease defined as document viral load (VL) <50 copies/mL and CD4 count >200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months)
  2. Use of oral, parenteral, or high-dose inhaled glucocorticoids
  3. Has an active neoplastic disease (excluding non-melanoma skin cancer), including those who used anti-cancer chemotherapy or radiation therapy during the current pregnancy
  4. Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
  5. Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound
  6. Anyone who is already enrolled or plans to enroll in another randomized clinical trial with any drug, vaccine or medical device. Co-enrollment in behavioral or other observational intervention studies are allowed at any time.
  7. 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.
  8. Anyone who is a relative of any research study personnel or is an employee supervised by study staff.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826640


Contacts
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Contact: Geeta K Swamy, MD 919-681-5220 geeta.swamy@duke.edu
Contact: Kristin E Weaver, BS 919-681-0308 kristin.weaver@duke.edu

Locations
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United States, Georgia
Centers for Disease Control and Prevention Not yet recruiting
Atlanta, Georgia, United States, 30333
Contact: Karen R Broder, MD       krb2@cdc.gov   
Contact: Naomi Tepper, MD       gdq2@cdc.gov   
Principal Investigator: Karen R Broder, MD         
Sub-Investigator: Naomi Tepper, MD         
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Stephen I Pelton, MD       spelton@bu.edu   
Contact: Glenn Markenson, MD       glenn.markenson@bmc.org   
Principal Investigator: Stephen I Pelton, MD         
Sub-Investigator: Glenn Markenson, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Geeta K Swamy, MD    919-681-5220    geeta.swamy@duke.edu   
Contact: Kristin E Weaver, BS    919-681-0308    kristin.weaver@duke.edu   
Principal Investigator: Geeta K Swamy, MD         
Sub-Investigator: Sarah K Dotters-Katz, MD, MEd         
Sub-Investigator: Emmanuel Walter, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Elizabeth Schlaudecker, MD    513-803-0747    elizabeth.schlaudecker@cchmc.org   
Contact: Mary Allen Staat, MD, MPH       mary.staat@cchmc.org   
Principal Investigator: Elizabeth Schlaudecker, MD, MPH         
Sub-Investigator: Mary Allen Staat, MD, MPH         
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Investigators
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Principal Investigator: Geeta K Swamy, MD Duke University
Principal Investigator: Karen R Broder, MD Centers for Disease Control and Prevention
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04826640    
Other Study ID Numbers: Pro00107518
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
COVID-19 Vaccination
Immunizations in Pregnancy