COVID-19 vaccines in pregnancy

Phase 2

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN15279830
• Lead Sponsor: St George's, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-14
• Last Update Posted: 20 November 2023
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 319

Inclusion Criteria

1. Healthy women =18 years of age who are between 13 0/7 and 34 0/7 weeks’ gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for obstetric complications
2. Able and willing (in the investigator’s opinion) to comply with all study requirements
3. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures
4. Willing and able to give informed consent prior to study enrolment
5. No contraindication to the specific vaccine to be administered in the study, according to the Green Book

Exclusion Criteria

1. Previous microbiological (based on a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19
2. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the study vaccine candidate (with the exception of anti-D immunoglobulin)
3. Previous vaccination with any COVID-19 vaccine (main cohort); prior receipt of one dose of a COVID-19 vaccine is permitted (sub-study)
4. Any confirmed or suspected immunosuppressive or immunodeficient state; chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting =14 days)
5. Any contraindication to the specific vaccine to be administered in the study, according to the Green Book or to the Summary of Product Characteristics for a specific vaccine
6. Current major illness of the mother or conditions of the fetus that, in the investigator’s judgment, will substantially increase the risk associated with the participant’s participation in, and completion of, the study or could preclude the evaluation of the participant’s response, including but not limited to the following:
6.1. Uncontrolled gestational hypertension
6.2. Preeclampsia-eclampsia
6.3. Placental abnormality
6.4. Polyhydramnios or oligohydramnios
6.5. Significant bleeding or blood clotting disorder
6.6. Uncontrolled gestational diabetes
6.7. Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth
6.8. Prior stillbirth or neonatal death, preterm delivery (=34 weeks), or previous infant with a known genetic disorder or major congenital anomaly

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. SARS-COV-2 IgG-specific antibody concentrations measured by ELISA from blood samples collected from vaccinated maternal subjects at delivery<br> 2. Occurrence of solicited local and general adverse events (AEs) that occur during a 7-day follow-up period after each vaccination (i.e., the day of vaccination and 6 subsequent days), measured using diary data entry (solicited AE) from Day 0 to Day 6<br> 3. Occurrence of unsolicited AEs that occur during a 30-day follow-up period after vaccination (i.e., the day of vaccination and 29 subsequent days), measured using diary data entry (unsolicited AE) from Day 0 to Day 29<br>