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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509947
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief 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 stable underlying conditions.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.COV2.S Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : January 8, 2021
Estimated Study Completion Date : October 26, 2021

Arm Intervention/treatment
Experimental: 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.
Biological: Ad26.COV2.S
Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
Other Names:
  • JNJ-78436735
  • Ad26COVS1

Experimental: 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.
Biological: Ad26.COV2.S
Ad26.COV2.S will be administered as IM injection at 2-dose (high and low) levels.
Other Names:
  • JNJ-78436735
  • Ad26COVS1

Placebo Comparator: 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.
Biological: Placebo
Placebo will be administered as IM injection.




Primary Outcome Measures :
  1. 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) ]
    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.

  2. Number of Participants with Solicited Local AEs for 7 days after Second Vaccination [ Time Frame: Day 64 (7 days after second vaccination on Day 57) ]
    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.

  3. Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination [ Time Frame: Day 8 (7 days after first vaccination on Day 1) ]
    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.

  4. Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination [ Time Frame: Day 64 (7 days after second vaccination on Day 57) ]
    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.

  5. Number of Participants with Unsolicited AEs for 28 days after First Vaccination [ Time Frame: Day 29 (28 days after first vaccination on Day 1) ]
    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.

  6. Number of Participants with Unsolicited AEs for 28 days after Second Vaccination [ Time Frame: Day 85 (28 days after second vaccination on Day 57) ]
    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.

  7. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Neutralization as measured by Virus Neutralization Assay (VNA) [ Time Frame: Up to 12 months ]
    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.

  2. SARS-CoV-2-Binding Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) [ Time Frame: Up to 12 months ]
    SARS-CoV-2 binding antibodies will be measured by ELISA to analyse the antibodies binding to the SARS-CoV-2 S protein.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509947


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Japan
Souseikai Hakata Clinic Recruiting
Fukuoka, Japan, 812-0025
SOUSEIKAI PS Clinic Recruiting
Fukuoka, Japan, 8120025
Souseikai Fukuoka Mirai Hospital Recruiting
Fukuoka, Japan, 813-0017
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04509947    
Other Study ID Numbers: CR108871
VAC31518COV1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No