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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04765384
Registration number
NCT04765384
Ethics application status
Date submitted
19/02/2021
Date registered
21/02/2021
Date last updated
8/11/2023
Titles & IDs
Public title
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
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Scientific title
An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
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Secondary ID [1]
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2020-005330-14
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Secondary ID [2]
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CR108962
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Universal Trial Number (UTN)
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Trial acronym
HORIZON 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19 Prevention
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Ad26.COV2.S
Experimental: Groups 1-4: Ad26.COV2.S (One Dose) - Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Other interventions: Ad26.COV2.S
Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution
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Assessment method [1]
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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 vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
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Timepoint [1]
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7 days after vaccination or until resolution (Up to Day 8)
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Primary outcome [2]
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Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution
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Assessment method [2]
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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) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
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Timepoint [2]
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7 days after vaccination or until resolution (Up to Day 8)
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Primary outcome [3]
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Number of Participants with Unsolicited AEs
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Assessment method [3]
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Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
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Timepoint [3]
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28 days after vaccination (Up to Day 29)
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Primary outcome [4]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 16 months
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Primary outcome [5]
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Number of Participants with Adverse Events of Special Interest (AESIs)
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Assessment method [5]
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Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
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Timepoint [5]
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Up to 16 months
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Primary outcome [6]
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Number of Participants with Medically-attended Adverse Events (MAAEs)
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Assessment method [6]
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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.
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Timepoint [6]
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6 months after vaccination (Up to Day 183)
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Primary outcome [7]
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Number of Participants with AEs leading to Discontinuation
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 16 months
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Primary outcome [8]
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Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination
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Assessment method [8]
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Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after vaccination will be reported.
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Timepoint [8]
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28 days after vaccination (Day 29)
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Secondary outcome [1]
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Group 4: Number of Adult Participants with Solicited Local AEs for 7 Days After Booster Vaccination or Until Resolution
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Assessment method [1]
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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 booster vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
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Timepoint [1]
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Up to 7 days after booster vaccination or until resolution (up to 16 months)
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Secondary outcome [2]
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Group 4: Number of Adult Participants with Solicited Systemic AEs for 7 Days After Booster Vaccination or Until Resolution
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Assessment method [2]
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Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (Day of booster vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
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Timepoint [2]
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Up to 7 days after booster vaccination or until resolution (up to 16 months)
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Secondary outcome [3]
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Group 4: Number of Adult Participants with Unsolicited AEs For 28 Days After Booster Vaccination
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Assessment method [3]
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Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.
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Timepoint [3]
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Up to 28 days after booster vaccination
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Secondary outcome [4]
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Group 4: Number of Adult Participants with SAEs Throughout the Study (From Booster Vaccination Until End of the Study [EOS])
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 16 months
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Secondary outcome [5]
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Group 4: Number of Adult Participants with AESIs Throughout the Study (From Booster Vaccination Until EOS)
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Assessment method [5]
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Number of adult participants with AESIs throughout the study (from booster vaccination until EOS) will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
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Timepoint [5]
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Up to 16 months
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Secondary outcome [6]
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Group 4: Number of Adult Participants with MAAEs Until 6 Months After Booster Vaccination
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Assessment method [6]
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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.
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Timepoint [6]
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6 months after booster vaccination
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Secondary outcome [7]
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Number of Adult Participants with AEs leading to Discontinuation (During the Entire Study)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 16 months
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Secondary outcome [8]
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Number of Adult Participants with Pregnancy Outcomes
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Assessment method [8]
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Number of adult participants with pregnancy outcomes (including, live term birth, live preterm birth, stillbirth, and abortion) (non-exhaustive) will be reported.
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Timepoint [8]
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Up to 6 months
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Secondary outcome [9]
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Number of Adult Participants with Pregnancy Related AEs
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Assessment method [9]
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Number of adult 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.
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Timepoint [9]
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Up to 6 months
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Secondary outcome [10]
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Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay, at all Blood Collection Timepoints in Adult Participants
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Assessment method [10]
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Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay, at all blood collection timepoints in adult participants will be reported.
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Timepoint [10]
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Up to 16 months
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Secondary outcome [11]
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Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days After Vaccination in Adult Participants
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Assessment method [11]
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Serological response to vaccination as measured by VNA titers, 28 days after vaccination in adult participants will be reported.
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Timepoint [11]
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28 days after vaccination (Day 29)
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Secondary outcome [12]
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Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) in Adult Participants
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Assessment method [12]
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Serological response to booster vaccination measured by binding (S-ELISA and/or equivalent assay) in adult participants will be reported.
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Timepoint [12]
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Up to 16 months
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Secondary outcome [13]
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Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants
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Assessment method [13]
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Serological response to booster vaccination measured by neutralizing (VNA) antibody titers in adult participants will be reported
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Timepoint [13]
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Up to 16 months
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Secondary outcome [14]
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Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay in Infants and Neonates
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Assessment method [14]
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Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood) and up to 2 months and 6 months of age.
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Timepoint [14]
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From birth up to 2 and 6 months
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Secondary outcome [15]
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Serological Response to Vaccination as Measured by VNA Titers at Birth in Neonates and Infants
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Assessment method [15]
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Serological response to vaccination as measured by VNA titers will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood).
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Timepoint [15]
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At birth
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Secondary outcome [16]
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Number of Neonates and Infants with SAEs
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Assessment method [16]
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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 12 months of age will be reported.
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Timepoint [16]
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From birth up to 12 months
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Secondary outcome [17]
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Number of Neonates and Infants with AESIs
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Assessment method [17]
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Number of neonates and infants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
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Timepoint [17]
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From birth up to 12 months
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Secondary outcome [18]
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Number of Neonates and Infants with MAAEs
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Assessment method [18]
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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.
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Timepoint [18]
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From birth up to 6 months
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Secondary outcome [19]
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Number of Neonates and Infants with AEs leading to Study Discontinuation
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Assessment method [19]
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Number of neonates and infants (born to adult participants who received vaccination) with AEs leading to discontinuation from birth up to 12 months of age will be reported.
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Timepoint [19]
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From birth up to 12 months
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Secondary outcome [20]
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Number of Neonates and Infants with or without any Complications, Anomalies and Deaths
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Assessment method [20]
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Number of neonates and infants with or without any complication, anomalies and death will be reported. This will also include normal neonate, term neonate with or without complications, preterm neonate with or without complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for gestational age measured from birth up to 12 months of age (non exhaustive).
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Timepoint [20]
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From birth up to 12 months
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Eligibility
Key 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 their last COVID-19 vaccination with an
authorized/licensed COVID-19 vaccine (at least 4 months prior to first study
vaccination) or is COVID 19 vaccine-naïve
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
98
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Mississippi
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Country [2]
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0
United States of America
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State/province [2]
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0
Nebraska
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New Mexico
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Texas
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Country [5]
0
0
Brazil
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State/province [5]
0
0
Belo Horizonte
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Country [6]
0
0
Brazil
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State/province [6]
0
0
Criciúma
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Country [7]
0
0
Brazil
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State/province [7]
0
0
Marilia
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Country [8]
0
0
Brazil
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State/province [8]
0
0
Natal
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Country [9]
0
0
Brazil
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State/province [9]
0
0
Porto Alegre
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Country [10]
0
0
Brazil
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State/province [10]
0
0
Sao Bernardo do Campo
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Country [11]
0
0
Brazil
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State/province [11]
0
0
Sao Jose do Rio Preto
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Country [12]
0
0
Brazil
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State/province [12]
0
0
Sorocaba
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Country [13]
0
0
Brazil
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State/province [13]
0
0
São Paulo
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Country [14]
0
0
South Africa
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State/province [14]
0
0
Dennilton
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Country [15]
0
0
South Africa
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State/province [15]
0
0
Johannesburg
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Country [16]
0
0
South Africa
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State/province [16]
0
0
Mamelodi East
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Country [17]
0
0
South Africa
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State/province [17]
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0
Soweto
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Vaccines & Prevention B.V.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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 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 schedule during the second and/or third trimester
of pregnancy, 28 days after vaccination.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04765384
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Janssen Vaccines & Prevention B.V. Clinical Trial
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Address
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Janssen Vaccines & Prevention B.V.
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
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0
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Country
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0
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Phone
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0
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Fax
0
0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04765384
Download to PDF