Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
250 participants
INTERVENTIONAL
2020-08-11
2021-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Ad26.COV2.S: High Dose
Participants (healthy adults aged greater than or equal to (\>=) 20 to less than or equal to (\<=) 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive intramuscular (IM) injection of Ad26.COV2.S at high dose, as 2-dose schedule on Day 1 and Day 57.
Ad26.COV2.S
Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
Ad26.COV2.S: Low Dose
Participants (healthy adults aged \>= 20 to \<= 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive IM injection of Ad26.COV2.S at low dose, as 2-dose schedule on Day 1 and Day 57.
Ad26.COV2.S
Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
Placebo
Participants (healthy adults aged \>= 20 to \<= 55 years \[cohort 1\] and \>= 65 years \[cohort 2\]) will receive IM injection of placebo on Day 1 and Day 57.
Placebo
Placebo will be administered as IM injection.
Interventions
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Ad26.COV2.S
Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
Placebo
Placebo will be administered as IM injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Contraceptive (birth control) use by women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either (a) not of childbearing potential; (b) of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (\<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. The investigators should evaluate the potential for contraceptive method failure (example, noncompliance, recently initiated) in relationship to the first vaccination. Highly effective methods for this study include: (1) hormonal contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); (ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); (2) intrauterine device (IUD); (3) intrauterine hormone-releasing system (IUS); (4) bilateral tubal occlusion/litigation procedure; (5) vasectomized partner (the vasectomized partner should be the sole partner for that participant; (6) sexual abstinence. Applicable to Cohort 2 only: Before randomization, a woman must be (a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) or permanently sterile; and (b) not intending to conceive by any method.
* All female participants of childbearing potential must: have a negative highly sensitive urine or serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccine administration
* A male participant must agree not to donate sperm for the purpose of reproduction for a minimum 28 days after receiving the dose of study vaccine
* 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
Exclusion Criteria
* 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 history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
* Participant previously received a coronavirus vaccine
* Participant has a positive molecular test result for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) at screening
* Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason
20 Years
ALL
Yes
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Souseikai Hakata Clinic
Fukuoka, , Japan
SOUSEIKAI PS Clinic
Fukuoka, , Japan
Souseikai Fukuoka Mirai Hospital
Fukuoka, , Japan
Countries
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References
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Tsuchiya Y, Tamura H, Fujii K, Numaguchi H, Toyoizumi K, Liu T, Le Gars M, Cardenas V, Eto T. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan. Vaccine. 2023 Feb 24;41(9):1602-1610. doi: 10.1016/j.vaccine.2023.01.006. Epub 2023 Jan 5.
Other Identifiers
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VAC31518COV1002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108871
Identifier Type: -
Identifier Source: org_study_id