A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)

Overview

The purpose of this study is to assess the safety and reactogenicity of 2 dose levels of Ad26.COV2.S or placebo, administered intramuscularly (IM) as a 1-dose or 2-dose schedule, in adult participants during the second and/or third trimester of pregnancy; to assess the humoral immune response in peripheral blood of adult participants, to 2 dose levels of Ad26.COV2.S or placebo, administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination and as a 2-dose schedule during the second and/or third trimester of pregnancy, 28 days after the second vaccination.

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 16, 2023

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 adult participants, the total study duration from screening until the last follow-up visit will be between 13 to 17 months. The study will consist of a screening phase (1 to 28 days), vaccination phase (1 to 3 months) and a follow up phase (up to 12 months post-partum [PP]). For neonates/infants (born to adult participants who received vaccination) the total study duration from birth until the last follow-up visit will be approximately 12 months. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs).

Interventions

  • Biological: Ad26.COV2.S
    • Adult participants in Groups 1, 3, 5, 6, 8 and 9 will receive IM injection of Ad26.COV2.S.
  • Other: Placebo
    • Adult participants in Groups 2, 4, 7 and 10 will receive IM injection of matching placebo.

Arms, Groups and Cohorts

  • Experimental: Groups 1 and 5: Ad26.COV2.S (1 Dose Low Dose)
    • Participants (Group 1: with gestation greater than or equal to [>=] 20 to less than or equal to [<=] 36 weeks and Group 5: with gestation >= 20 to less than [<] 28 weeks and >= 28 to <= 36 weeks) will receive 1 dose of Ad26.COV2.S (low dose) intramuscular (IM) injection on Day 1.
  • Experimental: Groups 3 and 6: Ad26.COV2.S (1 Dose Standard Dose)
    • Participants (Group 3: with gestation >= 20 to <= 36 weeks and Group 6: with gestation >= 20 to < 28 weeks and at >= 28 to <= 36 weeks) will receive 1 dose of Ad26.COV2.S (standard dose) IM injection on Day 1.
  • Placebo Comparator: Groups 2, 4 and 7: Placebo (1 Dose)
    • Participants (Groups 2 and 4: with gestation >= 20 to <= 36 weeks and Group 7: with gestation >=20 to < 28 weeks and at >=28 to <= 36 weeks) will receive 1 dose of matching placebo IM injection on Day 1.
  • Experimental: Group 8: Ad26.COV2.S (2 Doses Low Dose)
    • Participants (Group 8: with gestation >= 20 to < 28 weeks) will receive 2 doses of Ad26.COV2.S (low dose) IM injection on Day 1 and Day 57.
  • Experimental: Group 9: Ad26.COV2.S (2 Doses Standard Dose)
    • Participants (Group 9: with gestation >= 20 to <28 weeks) will receive 2 doses of Ad26.COV2.S (standard dose) IM injection on Day 1 and Day 57.
  • Placebo Comparator: Group 10: Placebo (2 Doses)
    • Participants (Group 10: with gestation >= 20 to < 28 weeks) will receive 2 doses of matching placebo IM injection on Day 1 and Day 57.

Clinical Trial Outcome Measures

Primary Measures

  • Groups 1-10: Number of Participants with Solicited Local Adverse Events (AEs)
    • Time Frame: 7 days after each vaccination (Up to Day 64)
    • An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
  • Groups 1-10: Number of Participants with Solicited Systemic AEs
    • Time Frame: 7 days after each vaccination (Up to Day 64)
    • An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
  • Groups 1-10: Number of Participants with Unsolicited AEs
    • Time Frame: 28 days after each vaccination (Up to Day 85)
    • An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant’s reactogenicity diary.
  • Groups 1-10: Number of Participants with Serious Adverse Events (SAEs)
    • Time Frame: Up to 2 years and 3 months
    • SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
  • Groups 1-10: Number of Participants with Medically-attended Adverse Events (MAAEs)
    • Time Frame: 6 months after last vaccination (Up to Day 239)
    • MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
  • Groups 1-10: Number of Participants with MAAEs leading to Discontinuation
    • Time Frame: Up to 2 years and 3 months
    • MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
  • Groups 1-10: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
    • Time Frame: 28 days after first vaccination (Day 29)
    • Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after first vaccination will be reported.
  • Groups 1-10: Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After First Vaccination
    • Time Frame: 28 days after first vaccination (Day 29)
    • Number of participants with antibody GMC (S-ELISA, EU/mL), 28 days after first vaccination will be reported.
  • Groups 8-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Second Vaccination
    • Time Frame: 28 days after second vaccination (Day 85)
    • Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL), 28 days after second vaccination will be reported.
  • Groups 8-10: Number of Participants with Antibody GMC 28 Days After Second Vaccination
    • Time Frame: 28 days after second vaccination (Day 85)
    • Number of participants with antibody GMC (S-ELISA, EU/mL), 28 days after second vaccination will be reported.

Secondary Measures

  • Groups 1-10: Number of Participants with Pregnancy Outcomes
    • Time Frame: Up to 2 years and 3 months
    • Number of participants with pregnancy outcomes (including, live birth without or with congenital anomalies, spontaneous abortion, elective termination without or with fetal defects, still birth without or with fetal defects) will be reported.
  • Groups 1-10: Number of Participants with Pregnancy Related AEs
    • Time Frame: Up to 2 years and 3 months
    • Number of participants with pregnancy-related AEs including: gestational diabetes, gestational hypertension, premature rupture of membranes, premature labor, premature uterine contractions, poor or restricted fetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine hemorrhage (non-exhaustive) will be reported.
  • Number of Neonates and Infants with Congenital Anomalies
    • Time Frame: From birth up to 12 months
    • Number of neonates and infants (born to adult participants who received vaccination) with congenital anomalies, such as small for gestational age, preterm birth, neonatal death, and failure to thrive measured from birth up to 12 months of age (non exhaustive) will be reported.
  • Number of Neonates and Infants with SAEs
    • Time Frame: From birth up to 12 months
    • Number of neonates and infants (born to adult participants who received vaccination) with SAEs including multisystem inflammatory syndrome in children (MIS-C) from birth up to end of study (12 months) will be reported. Patients with MIS-C usually present with persistent fever, fatigue and a variety of signs and symptoms including multiorgan (example, cardiac, gastrointestinal, renal, hematologic, dermatologic, neurologic) involvement, elevated inflammatory markers and, in severe cases, hypotension and shock.
  • Number of Neonates and Infants with MAAEs
    • Time Frame: From birth up to 6 months
    • Number of neonates and infants (born to adult participants who received vaccination) with MAAEs from birth up to 6 months of age will be reported.
  • Number of Neonates and Infants with MAAEs leading to Study Discontinuation
    • Time Frame: From birth up to 12 months
    • Number of neonates and infants (born to adult participants who received vaccination) with MAAEs leading to discontinuation from birth up to 12 months of age will be reported.
  • Serological Response to Vaccination as Measured by ELISA
    • Time Frame: From birth up to 2 months, 6 months, 12 months
    • Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) will be reported for neonates and infants (born to adult participants who received vaccination) at birth and up to 2 months, 6 months, and 12 months of age.
  • Number of Neonates and Infants with Antibody GMC
    • Time Frame: From birth up to 2 months, 6 months, 12 months
    • Number of neonates and infants (born to adult participants who received vaccination) with antibody GMC (S-ELISA, EU/mL) will be reported at birth and up to 2 months, 6 months, and 12 months of age.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 – Participant will be included on the basis of physical examination, medical history, and vital signs – Participant will be at second or third trimester of pregnancy, that is, Week 20 to Week 36 of gestation, at the time of randomization, based on ultrasound at the time of screening (unless performed elsewhere within 28-days prior to vaccination) – 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 Exclusion Criteria:

  • Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) – Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) – 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 – 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 neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood – Participant has a positive diagnostic test result for past (serological testing) or current (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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Janssen Vaccines & Prevention B.V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Vaccines & Prevention B.V. Clinical Trial, Study Director, Janssen Vaccines & Prevention B.V.
  • Overall Contact(s)
    • Study Contact, 844-434-4210, JNJ.CT@sylogent.com

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