Observational Maternal COVID-19 Vaccination Study

• ClinicalTrials.gov Identifier: NCT04826640
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: November 23, 2021
• Sponsor: Duke University
• Collaborators: Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati; Boston Medical Center
• Information provided by (Responsible Party): Duke University

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

• Principal Investigator: Geeta K Swamy, MD; Duke University
• Principal Investigator: Karen R Broder, MD; Centers for Disease Control and Prevention

  Study Documents (Full-Text)

Documents provided by Duke University:

Study Protocol  [PDF] October 27, 2021

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04826640
• Other Study ID Numbers: Pro00107518
• First Posted: April 1, 2021
• Last Update Posted: November 23, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases