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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04765384




Registration number
NCT04765384
Ethics application status
Date submitted
19/02/2021
Date registered
21/02/2021

Titles & IDs
Public title
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
Scientific title
An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
Secondary ID [1] 0 0
VAC31518COV2004
Secondary ID [2] 0 0
CR108962
Universal Trial Number (UTN)
Trial acronym
HORIZON 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Prevention 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: Ad26.COV2.S
Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination
Timepoint [1] 0 0
From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)
Primary outcome [2] 0 0
Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination
Timepoint [2] 0 0
From first vaccination on Day 1 up to 7 days post first vaccination (up to Day 8)
Primary outcome [3] 0 0
Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination
Timepoint [3] 0 0
From first vaccination on Day 1 up to 28 days post first vaccination (up to Day 29)
Primary outcome [4] 0 0
Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS)
Timepoint [4] 0 0
From first vaccination on Day 1 until end of study (up to post-partum [PP] Day 366 [Day 15 up to Day 554])
Primary outcome [5] 0 0
Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS
Timepoint [5] 0 0
From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])
Primary outcome [6] 0 0
Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination
Timepoint [6] 0 0
From first vaccination on Day 1 until 6 months post first vaccination (up to Day 183)
Primary outcome [7] 0 0
Number of Adult Participants With AEs Leading to Study Discontinuation
Timepoint [7] 0 0
From first vaccination on Day 1 until end of study (up to PP Day 366 [Day 15 up to Day 554])
Primary outcome [8] 0 0
Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination
Timepoint [8] 0 0
28 days post first vaccination on Day 1 (at Day 29)
Secondary outcome [1] 0 0
Group 4: Number of Adult Participants With Solicited Local AEs for 7 Days Post Booster Vaccination
Timepoint [1] 0 0
7 days post booster vaccination (Day 84 up to Day 371)
Secondary outcome [2] 0 0
Group 4: Number of Adult Participants With Solicited Systemic AEs for 7 Days Post Booster Vaccination
Timepoint [2] 0 0
7 days post booster vaccination (Day 84 up to Day 371)
Secondary outcome [3] 0 0
Group 4: Number of Adult Participants With Unsolicited AEs for 28 Days Post Booster Vaccination
Timepoint [3] 0 0
28 days post booster vaccination (Day 84 up to Day 392)
Secondary outcome [4] 0 0
Group 4: Number of Adult Participants With SAEs Post Booster Vaccination Until EOS
Timepoint [4] 0 0
From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])
Secondary outcome [5] 0 0
Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS
Timepoint [5] 0 0
From booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])
Secondary outcome [6] 0 0
Group 4: Number of Adult Participants With MAAEs Until 6 Months Post Booster Vaccination
Timepoint [6] 0 0
6 months post booster vaccination (Day 84 up to Day 546)
Secondary outcome [7] 0 0
Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS
Timepoint [7] 0 0
From post booster vaccination (Day 84 up to Day 364) until EOS (up to PP Day 366 [Day 366 up to Day 554])
Secondary outcome [8] 0 0
Number of Adult Participants With Pregnancy Outcomes
Timepoint [8] 0 0
From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163)
Secondary outcome [9] 0 0
Number of Adult Participants With Pregnancy Related AEs Throughout Pregnancy
Timepoint [9] 0 0
From first vaccination on Day 1 until PP Day 1 (Day 7 up to Day 163)
Secondary outcome [10] 0 0
Serological Response to First Vaccination as Measured by S-ELISA in Adult Participants at All Blood Collection Timepoints Post First Vaccination
Timepoint [10] 0 0
Day 1, Day 29, PP Day 1 (Day 7 up to Day 163), PP Day 183 (Day 189 up to Day 345)
Secondary outcome [11] 0 0
Serological Response to First Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 28 Days in Adult Participants Post First Vaccination
Timepoint [11] 0 0
28 days post first vaccination on Day 1 (at Day 29)
Secondary outcome [12] 0 0
Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Timepoint [12] 0 0
Booster Day 1 (Day 84 up to Day 364), Booster Day 29 (Day 112 up to Day 392)
Secondary outcome [13] 0 0
Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants at Blood Collection Time Points Post Booster Vaccination
Timepoint [13] 0 0
Booster Day 1 (Day 84 up to Day 364), Booster Day 29 (Day 112 up to Day 392)
Secondary outcome [14] 0 0
Serological Response to Vaccination as Measured by S-ELISA at Birth (That is, in Cord Blood) and at 2 Months and 6 Months of Age in Neonates and Infants Born to Adult Participants
Timepoint [14] 0 0
At birth (postnatal [PN] Day 1 [Day 7 up to Day 163]), 2 months (up to PN Day 61 [Day 67 up to Day 223]) and 6 months (up to PN Day 183 [Day 189 up to Day 345])
Secondary outcome [15] 0 0
Serological Response to Vaccination as Measured by VNA Titers at Birth (That is, in Cord Blood) in Neonates and Infants Born to Adult Participants
Timepoint [15] 0 0
At Birth (PN Day 1 [Day 7 up to Day 163])
Secondary outcome [16] 0 0
Number of Neonates and Infants With SAEs (Including MIS-C) From Birth Up to 12 Months of Age in Neonates and Infants Born to Adult Participants
Timepoint [16] 0 0
From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528])
Secondary outcome [17] 0 0
Number of Neonates and Infants With AESIs From Birth Until 12 Months of Age in Neonates and Infants Born to Adult Participants
Timepoint [17] 0 0
From birth (PN Day 1 [Day 7 up to Day 163]) until 12 months of age (up to PN Day 366 [Day 372 up to Day 528])
Secondary outcome [18] 0 0
Number of Neonates and Infants With MAAEs From Birth Until 6 Months of Age in Neonates and Infants Born to Adult Participants
Timepoint [18] 0 0
From birth (PN Day 1 [Day 7 up to Day 163]) until 6 months of age (up to PN 183 [Day 189 up to Day 345])
Secondary outcome [19] 0 0
Number of Neonates and Infants With AEs Leading to Study Discontinuation From Birth Until Study Discontinuation
Timepoint [19] 0 0
From birth (PN Day 1 [Day 7 up to Day 163]) until study discontinuation (until 12 months of age [up to PN Day 366 {Day 372 up to Day 528}])
Secondary outcome [20] 0 0
Number of Neonates and Infants With Different Birth Outcomes From Birth Up to 12 Months of Age
Timepoint [20] 0 0
From birth (PN Day 1 [Day 7 up to Day 163]) up to 12 months of age (up to PN Day 366 [Day 372 up to Day 528])

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/11/2023
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Mississippi
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Brazil
State/province [5] 0 0
Belo Horizonte
Country [6] 0 0
Brazil
State/province [6] 0 0
Criciúma
Country [7] 0 0
Brazil
State/province [7] 0 0
Marilia
Country [8] 0 0
Brazil
State/province [8] 0 0
Natal
Country [9] 0 0
Brazil
State/province [9] 0 0
Porto Alegre
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Bernardo do Campo
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Jose do Rio Preto
Country [12] 0 0
Brazil
State/province [12] 0 0
Sorocaba
Country [13] 0 0
Brazil
State/province [13] 0 0
São Paulo
Country [14] 0 0
South Africa
State/province [14] 0 0
Dennilton
Country [15] 0 0
South Africa
State/province [15] 0 0
Johannesburg
Country [16] 0 0
South Africa
State/province [16] 0 0
Mamelodi East
Country [17] 0 0
South Africa
State/province [17] 0 0
Soweto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Vaccines & Prevention B.V.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Vaccines & Prevention B.V. Clinical Trial
Address 0 0
Janssen Vaccines & Prevention B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04765384