HealthyPhase 1NCT04354480
A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older
A Phase 1 study testing RSV Vaccine in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
Trial summary
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RSV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 15 May 2020to 20 Jan 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
- Before randomization, a woman must be: postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause); not intending to conceive by any methods
- 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
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs , and 12-lead electrocardiogram (ECG) performed at screening
- From the time of vaccination through 3 months, participant agrees not to donate blood
- Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
Who cannot join
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has 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 chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- Participant has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Single Vaccination of an Ad26.RSV.preF-based Regimen in Japanese Adults Aged 60 Years and Older
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
- Conditions
- Healthy
- Being tested
- RSV Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV VaccineBiological
Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.
PlaceboOther
Participants will receive a single IM injection of matching placebo on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| RSV Vaccine | Experimental | Participants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1. Receives: Biological: RSV Vaccine |
| Placebo | Placebo comparator | Participants will receive single IM injection in the deltoid muscle of matching placebo on Day 1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
Measured: 7 days after vaccination (Day 1 to Day 8)
Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination
Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
Measured: 7 days after vaccination (Day 1 to Day 8)
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Measured: 28 days after vaccination (Day 1 to Day 29)
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAEs will be evaluated. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: First vaccination (Day 1) to the end of the study (up to Day 183)
Secondary outcomes (3)
RSV Neutralization Assay
Analysis of neutralizing antibodies to RSV A strain will be performed.
Measured: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
RSV Fusion Protein (F-Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by ELISA.
Measured: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
Interferon (IFN)-Gamma Enzyme-Linked Immunospot (ELISpot) Assay
RSV F-specific cellular immune responses elicited by the different vaccine regimens.
Measured: Day 1 (pre-vaccination) and Day 29 (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start15 May 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354480
- Sponsor's protocol ID
- CR108768
- Other IDs
- VAC18193RSV1006
- Status last verified
- Jan 2025
- First submitted
- 17 Apr 2020
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Eto T, Okubo Y, Momose A, Tamura H, Zheng R, Callendret B, Bastian AR, Comeaux CA. A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older. Influenza Other Respir Viruses. 2024 Jun;18(6):e13336. doi: 10.1111/irv.13336.
PubMed 38880785
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Single Vaccination of an Ad26.RSV.preF-based Regimen in Japanese Adults Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT04354480
- Acronym / sponsor ID
- CR108768
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSV Vaccine | Experimental | Biological: RSV VaccineParticipants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive single IM injection in the deltoid muscle of matching placebo on Day 1. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
- Before randomization, a woman must be: postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause); not intending to conceive by any methods
- 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
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs , and 12-lead electrocardiogram (ECG) performed at screening
- From the time of vaccination through 3 months, participant agrees not to donate blood
Key exclusion criteria (5 listed)
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has 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 chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- Participant has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV VaccineParticipants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1. | Biological | RSV Vaccine |
| PlaceboParticipants will receive a single IM injection of matching placebo on Day 1. | Other | Placebo |
Primary outcome
Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
Time frame: 7 days after vaccination (Day 1 to Day 8)
Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination
Time frame: 7 days after vaccination (Day 1 to Day 8)
Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
Number of Participants with Unsolicited AEs
Time frame: 28 days after vaccination (Day 1 to Day 29)
Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: First vaccination (Day 1) to the end of the study (up to Day 183)
Number of participants with SAEs will be evaluated. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
3 secondary outcomes
RSV Neutralization Assay
Time frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
RSV Fusion Protein (F-Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
Interferon (IFN)-Gamma Enzyme-Linked Immunospot (ELISpot) Assay
Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 38880785Eto T, Okubo Y, Momose A, Tamura H, Zheng R, Callendret B, Bastian AR, Comeaux CA. A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older. Influenza Other Respir Viruses. 2024 Jun;18(6):e13336. doi: 10.1111/irv.13336.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSV Vaccine in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site 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 6 inclusion and 5 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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) After Vaccination (time frame: 7 days after vaccination (Day 1 to Day 8)). The study lists 4 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 NCT04354480, 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 3 Feb 2025.