Observational Maternal COVID-19 Vaccination Study

A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Pregnant Women

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 7 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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • Centers for Disease Control and Prevention
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• 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.

Description

Inclusion Criteria:

1. Pregnant women 18-45 years of age at the time of consent, inclusive
2. Intention of receiving or within 1 day 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 or medications, such as antirejection/transplant regiments or immunomodulatory agents. Stable HIV disease is permitted per the following parameters:

   a. Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4 count >200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months

2. Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per the following parameters:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse pregnancy outcomes in pregnant women vaccinated with COVID-19 vaccine	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth after COVID-19 vaccination	As measured by proportions of preterm birth after COVID-19 vaccination	12 months
Combined fetal and neonatal death after COVID-19 vaccination	As measured by proportions of combined fetal and neonatal death after COVID-19 vaccination	12 months
Spontaneous abortion after COVID-19 vaccination	As measured by proportions of spontaneous abortion after COVID-19 vaccination	12 months
Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination	As measured by proportions of pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination	7 days
Women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination	As measured by proportion of women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination	3 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Boston Medical Center; Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Geeta K Swamy, MD, Duke University; Principal Investigator: Karen R Broder, MD, Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 Vaccination; Immunizations in Pregnancy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00107518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No