Purpose

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level, or 2-dose schedule at a lower dose level, if applicable in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose, or 2-dose schedule, if applicable, at a lower dose during the second and/or third trimester of pregnancy, 28 days after the first vaccination and 14 days after the second vaccination.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination - Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled - Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere) - 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 - Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study - Participant either received complete primary vaccination with an authorized/licensed COVID-19 vaccine (completed at least 6 months prior to first study vaccination) or is COVID 19 vaccine-naïve

Exclusion Criteria

  • Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) - Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) - Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - Participant has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood - Participant has a positive diagnostic test result (polymerase chain reaction [PCR] based viral ribonucleic acid [RNA] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between) - Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT) - Participant has a history of capillary leak syndrome (CLS)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Groups 1-4: Ad26.COV2.S (One Dose)
Participants who are previously vaccinated (Groups 1-3) and vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1 (if safety profile of such dose is acceptable per independent data monitoring committee [IDMC] review). Participants from group 4 may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
  • Biological: Ad26.COV2.S
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735, Ad26COVS1
Experimental
Groups 1-4: Ad26.COV2.S (Two Dose)
Participants who are previously vaccinated (Groups 1-3) and vaccine naïve (Group 4) will receive 2 doses of Ad26.COV2.S at a lower dose level on Day 1 and 57 (if safety profile after 1 dose at standard dose level is not acceptable per IDMC review). Participants from group 4 may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
  • Biological: Ad26.COV2.S
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735, Ad26COVS1

Recruiting Locations

Medpharmics, LLC
Gulfport, Mississippi 39503

Medpharmics, LLC
Albuquerque, New Mexico 87102

Maximos OB/GYN
League City, Texas 77573

More Details

NCT ID
NCT04765384
Status
Recruiting
Sponsor
Janssen Vaccines & Prevention B.V.

Study Contact

Study Contact
844-434-4210
JNJ.CT@sylogent.com

Detailed Description

There is an increased risk of severe coronavirus disease-2019 (COVID-19) during pregnancy, as well as an increased risk of adverse birth outcomes. Therefore, the aim of this study is to assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in the second and/or third trimester of pregnancy. Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein. For each adult participant, the total study duration from screening until the last follow-up visit will be approximately 16 months. The study will consist of a screening phase (28 days), vaccination period (study period from first vaccination to pregnancy completion/termination) and a follow-up period (up to 12 months post pregnancy completion/termination). For neonates/infants born to the participants in the study will be followed for approximately 12 months postpartum. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, pregnancy outcome, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.