COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN15279830

Dr Eva Galiza

egaliza@sgul.ac.uk

2021-10-14

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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

9

St George's; University of London

18

100

United Kingdom

Healthy volunteers

N/A

800

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

Phase 2

[{"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ one short boost 28 to 42 days", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ dTAP 28-42 days+ one long boost covid vaccine days 56 to 84\n", "treatment_id": 2342, "treatment_name": "Covid19 vaccine+diphtheria tetanus pertussis vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ one long boost 56-84 days\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one short boost 28 to 42 days\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one short boost 28 to 42 days + dTAP days 56 to 84\n", "treatment_id": 2342, "treatment_name": "Covid19 vaccine+diphtheria tetanus pertussis vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one long boost days 56 to 84\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 3;2;Day 1+ one boost 28-34 gestional weeks\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 4 (Participants will receive the same vaccine as given pre-pregnancy or in the first trimester of pregnancy);2;Day 1 + one boost \u2264 26 weeks gestation\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 4 (Participants will receive the same vaccine as given pre-pregnancy or in the first trimester of pregnancy);2;Day 1 + one boost > 26 weeks gestation\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]