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HealthyPhase 1NCT04509947

A Study of Ad26.COV2.S in Adults (COVID-19)

A Phase 1 study testing Ad26.COV2.S in people with Healthy, run by Janssen Pharmaceutical K.K. at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 to less than or equal to 55 years and greater than or equal to 65 years in good health with or without… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ad26.COV2.S
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
3 sitesJapan
Study dates
11 Aug 2020to 16 Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must have a body mass index (BMI) less than (<) 40.0 kilograms per meter square (kg/m^2)
  • 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

Who cannot join

  • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigators and after consultation with the sponsor
  • 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
  • Participants who are at increased risk of severe coronavirus disease-2019 (COVID-19), that is, participants with moderate-to-severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1, type 2, or gestational); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension; severe obesity; chronic kidney disease being treated with dialysis; participants who are immunocompromised (as outlined in other exclusion criteria); chronic liver disease, including cirrhosis; and participants who live in a nursing home or long-term care facility
  • 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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Souseikai Hakata Clinic

    Fukuoka, 812-0025

  • SOUSEIKAI PS Clinic

    Fukuoka, 812-0025

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 to less than or equal to 55 years and greater than or equal to 65 years in good health with or without stable underlying conditions.

Conditions
Healthy
Being tested
Ad26.COV2.S, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad26.COV2.SBiological

    Also called JNJ-78436735, Ad26COVS1

    Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.

  • PlaceboBiological

    Placebo will be administered as IM injection.

Study groups in NCT04509947
Study groupRoleWhat they receive
Ad26.COV2.S: High DoseExperimentalParticipants (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.
Receives: Biological: Ad26.COV2.S
Ad26.COV2.S: Low DoseExperimentalParticipants (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.
Receives: Biological: Ad26.COV2.S
PlaceboPlacebo comparatorParticipants (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.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination

    Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measured: Day 8 (7 days after first vaccination on Day 1)

  2. Number of Participants with Solicited Local AEs for 7 days after Second Vaccination

    Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measured: Day 64 (7 days after second vaccination on Day 57)

  3. Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination

    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.

    Measured: Day 8 (7 days after first vaccination on Day 1)

  4. Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination

    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.

    Measured: Day 64 (7 days after second vaccination on Day 57)

  5. Number of Participants with Unsolicited AEs for 28 days after First Vaccination

    Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measured: Day 29 (28 days after first vaccination on Day 1)

  6. Number of Participants with Unsolicited AEs for 28 days after Second Vaccination

    Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measured: Day 85 (28 days after second vaccination on Day 57)

  7. Number of Participants with Serious Adverse Events (SAEs)

    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: 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.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Neutralization as measured by Virus Neutralization Assay (VNA)

    SARS-CoV-2 neutralization will be measured by VNA to analyse the neutralizing antibodies to the wild-type virus and/or pseudovirion expressing S protein.

    Measured: Up to 12 months

  2. SARS-CoV-2-Binding Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    SARS-CoV-2 binding antibodies will be measured by ELISA to analyse the antibodies binding to the SARS-CoV-2 S protein.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start11 Aug 2020
  3. Primary completion22 Feb 2021
  4. Study completion16 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509947
Sponsor's protocol ID
CR108871
Other IDs
VAC31518COV1002
Status last verified
Nov 2021
First submitted
11 Aug 2020
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 36732164

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad26.COV2.S in people with Healthy, run by Janssen Pharmaceutical K.K. at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination (time frame: Day 8 (7 days after first vaccination on Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.

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