HealthyPhase 1NCT04306302
A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults
A Phase 1 study testing ExPEC10V in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ExPEC10V
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 13 Mar 2020to 24 Dec 2020
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be Japanese as determined by participant's verbal report
- Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
- Willing and able to adhere to the lifestyle restrictions
- Agrees not to donate blood until 12 weeks after receiving the study intervention
- Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study
Who cannot join
- Clinically significant 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 (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- 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)
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
- Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years
The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.
- Conditions
- Healthy
- Being tested
- ExPEC10V, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExPEC10VBiological
Also called VAC52416
Participants will receive a single IM injection of ExPEC10V.
PlaceboBiological
Participants will receive single IM injection of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Medium-dose ExPEC10V or Placebo: Group 1 | Experimental | Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1. Receives: Biological: ExPEC10V; Biological: Placebo |
| High-dose ExPEC10V or Placebo: Group 2 | Experimental | Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1. Receives: Biological: ExPEC10V; Biological: 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) Collected for 14 days post-Vaccination
Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination.
Measured: 14 days post-Vaccination (Up to Day 15)
Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination
Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
Measured: 14 days post-Vaccination (Up to Day 15)
Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination
Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary.
Measured: From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181
Number of participants with SAEs will be reported. 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: From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)
Secondary outcomes (2)
Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Measured: Days 15 and 30
Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)
Antibody titers for ExPEC10V will be determined by MOPA.
Measured: Day 15 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start13 Mar 2020
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT04306302
- Sponsor's protocol ID
- CR108778
- Other IDs
- VAC52416BAC1002
- Status last verified
- Jan 2021
- First submitted
- 11 Mar 2020
- Last updated
- 20 Jan 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years
- ClinicalTrials.gov ID
- NCT04306302
- Acronym / sponsor ID
- CR108778
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 12 Mar 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 purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium-dose ExPEC10V or Placebo: Group 1 | Experimental | Biological: ExPEC10V, Biological: PlaceboParticipants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1. |
| High-dose ExPEC10V or Placebo: Group 2 | Experimental | Biological: ExPEC10V, Biological: PlaceboParticipants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be Japanese as determined by participant's verbal report
- Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
- Willing and able to adhere to the lifestyle restrictions
- Agrees not to donate blood until 12 weeks after receiving the study intervention
- Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study
Key exclusion criteria (5 listed)
- Clinically significant 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 (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- 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)
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
- Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders
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 |
|---|---|---|
| ExPEC10VAlso: VAC52416Participants will receive a single IM injection of ExPEC10V. | Biological | High-dose ExPEC10V or Placebo: Group 2, Medium-dose ExPEC10V or Placebo: Group 1 |
| PlaceboParticipants will receive single IM injection of matching placebo. | Biological | High-dose ExPEC10V or Placebo: Group 2, Medium-dose ExPEC10V or Placebo: Group 1 |
Primary outcome
Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination
Time frame: 14 days post-Vaccination (Up to Day 15)
Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination.
Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination
Time frame: 14 days post-Vaccination (Up to Day 15)
Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination
Time frame: From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary.
Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181
Time frame: From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)
Number of participants with SAEs will be reported. 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.
2 secondary outcomes
Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay
Time frame: Days 15 and 30
Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)
Time frame: Day 15 and 30
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 20 Jan 2021.
- 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 ExPEC10V 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 5 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 20 Jan 2021. 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. 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) Collected for 14 days post-Vaccination (time frame: 14 days post-Vaccination (Up to Day 15)). 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?
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 20 Jan 2021.