A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
- Conditions
- Healthy Pregnant Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005330-14-ES
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
1. Participant is 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 45 years of age, inclusive, on the day of signing the ICF.
2. Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening, and must not have comorbidities related to an increased risk of severe COVID-19 or high-risk pregnancy. Participant may have underlying illnesses (eg,
stable/well-controlled HIV infection)*, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 or high-risk pregnancy.
* Stable/well-controlled HIV infection includes:
a. CD4 cell count =300 cells/µL.
b. HIV viral load <50 copies/mL.
c. Participant must be on a stable anti-retroviral treatment (ART) for 6 months (unless the change is due to tolerability, in which case the regimen can be for only the previous 3 months; changes in formulation are allowed) and the participant must be willing to continue his/her ART throughout the study as directed by his/her local physician.
3. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study.
4. Participant will be at 2nd or 3rd trimester of pregnancy, ie, Week 16 to Week 38 of gestation, at the time of vaccination, based on ultrasound at the time of screening (unless performed elsewhere within 28-days prior to vaccination).
5. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (eg, preeclampsia, premature birth during previous pregnancy).
2. Participants with risk factors (eg, multiple pregnancies [twins or higher order multiples], diabetes, high blood pressure, obesity [before pregnancy], epilepsy, thyroid disease, heart or blood disorders, poorly controlled asthma, or infections) or complications (eg, abnormal placenta position, fetal growth less than the 10th percentile for gestational age [fetal growth restriction], and rhesus [Rh] sensitization) for a high-risk pregnancy.
3. Participants with a family health history of congenital disorders or anomalies.
4. Participant with abnormal pregnancy screening testa (eg, ultrasound fetal abnormalities, maternal blood screen)
5. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature =38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine; vaccination at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
6. Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence.
7. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients.
8. Participant has abnormal function of the immune system resulting from:
a. Clinical conditions (eg, autoimmune disease, potential immune mediated disease or known or suspected immunodeficiency, chronic kidney disease [with dialysis]) expected to have an impact on the immune response elicited by the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment (eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.
b. Chronic (>10 days) or recurrent use of systemic corticosteroids at immunosuppressive doses within 6 months before administration of study vaccine and during the study.
Note: Ocular, topical or inhaled steroids are allowed.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of study vaccine and during the study
9. Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
10. Participant received or plans to receive:
a. Licensed live attenuated vaccines – within 28 days before or after planned administration of the 1st and 2nd study vaccinations
b. Other licensed (not live) vaccines – within 14 days before or after planned administration of the 1st and 2nd study vaccinations.
11. Participant received an investigational drug or used an invasive investigational medical device within 30 days, or received investigational immunoglobulin or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational va
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method