COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
There are four study cohorts: cohorts 1 and 2 will be the main study cohorts and 3 and 4 will be the sub-study cohorts
Participants in cohorts 2, 3 and 4 can receive the Tdap vaccination from the stud
Sponsors
St George's, University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SARS-COV-2 IgG-specific antibody concentrations measured by ELISA from blood samples collected from vaccinated maternal subjects at delivery 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal: 1. Pregnancy outcomes from Visit 1 up to 6 weeks after delivery. These include live birth with congenital anomalies, miscarriage, fetal death/stillbirth (antepartum or intrapartum), mode of delivery, elective/therapeutic termination. Reviewed at delivery and at 3 days, 14 days, and 42-48 days after delivery. 2. Occurrence of serious adverse events (SAEs), AEs leading to study withdrawal, and medically attended adverse events (MAAEs) from Visit 1 (Day 0) up to 6 weeks after delivery. Notification of SAE/AE/MAAE to site by participant from enrolment to 1 year after delivery/birth 3. Adverse event of special interest (AESI) from Visit 1 up to 6 weeks after delivery (Day 42 post-delivery). These include but are not limited to maternal death, hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, caesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth (premature preterm rupture of membranes, preterm labour, provider-initiated preterm birth), chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy, acute fatty liver of pregnancy), maternal sepsis. Notification of AESI to site by participant from enrolment to 6 weeks after delivery for the mother and up to 6 weeks after birth for the infant. 4. SARS-COV-2 IgG-specific antibody concentrations (and neutralizing antibody titres and cellular immune responses in subsets) measured by ELISA from blood samples collected from vaccinated maternal subjects at Day 0 (before vaccination), Day 28-42, Day 56-84, Day 84-112, Day 112-140, at delivery, between 4 weeks and 12 weeks, and at 12 months after delivery 5. SARS-COV-2 IgG-specific antibody concentrations (and neutralizing antibody titres and ce | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed