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HealthyPhase 1NCT02748967

A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants

A Phase 1 study testing ExPEC4V in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site 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 tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age. 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?
ExPEC4V
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteJapan
Study dates
Apr 2016to Aug 2016
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

  • Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study
  • Participant must be a man or woman greater than or equal to [> =] 20 years of age on the day of signing the ICF
  • A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until at least 3 months after study vaccine administration. A male participant must agree not to donate sperm until at least 3 months after study vaccine administration
  • Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of less than or equal to [< =] 30.0 kg/m^2
  • A male participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner uses occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

Who cannot join

  • Participant has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
  • Participant has current or a history of autoimmune disease
  • Participant has received an investigational drug (including investigational vaccines) within 90 days before vaccination in the study or is currently enrolled in an investigational study
  • Participant has received treatment with immunoglobulins or blood products in the 4 months before vaccination in the study or any plans to receive such treatment during the study
  • Participant has known or suspected congenital or acquired immunodeficiency (including leukemia, human immunodeficiency virus [HIV] seropositivity), has received immunosuppressive therapy (such as cyclosporine, anti-cancer chemotherapy, radiation therapy, or cytotoxic drugs) within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months, or has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen (HBsAg) and hepatitis C antibody, respectively

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Fukuoka

Other trials in Japan

About this study

Official title: Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.

Read the detailed description

This is a Phase 1 double-blind (neither the Investigator nor the participant know the treatment), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) parallel group, single center study in healthy Japanese participants aged greater than or equal to [> =] 20 years. A target of approximately 48 participants will be enrolled that are stratified according to their age in 2 groups: 24 participants > = 20 to less than [<] 50 years of age and 24 participants > = 50 years of age. Both groups will be randomized to a single vaccination with 1 of the 3 study dose levels of ExPEC4V or placebo (vaccine buffer). Participants will be enrolled in a dose ascending approach. Blood samples will be drawn on Days 1 (prevaccination), 15 and 30 for the assessment of immunogenicity. The study duration per participant will be approximately 38 days (Screening period and postvaccination follow-up included). Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
ExPEC4V, Placebo
Keywords
Healthy, ExPEC4V, JNJ-63871860, Safety

What participants receive

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

  • ExPEC4VDrug

    Also called JNJ-63871860

    Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.

  • PlaceboDrug

    Participant will receive single dose of Placebo on Day 1.

Study groups in NCT02748967
Study groupRoleWhat they receive
Group 1ExperimentalParticipants with age (greater than or equal to [>=] 20 to less than [<] 50 years) will receive single dose of 0.5 milliliter (mL) of ExPEC4V (4:4:4:4) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo
Group 2ExperimentalParticipants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo
Group 3ExperimentalParticipants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo
Group 4ExperimentalParticipants with age greater than or equal to [>=] 50 will receive single dose of 0.5 mL of ExPEC4V (4:4:4:4) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo
Group 5ExperimentalParticipants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo
Group 6ExperimentalParticipants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
Receives: Drug: ExPEC4V; Drug: Placebo

What is being measured

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

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to follow-up (30 days)

Secondary outcomes (2)

  1. Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)

    Measured: Up to Day 30

  2. Antibody Levels Against the ExPEC4V Measured by Opsonophagocytic Killing (OPK) Assay

    Measured: Up to Day 30

Timeline

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

  1. First posted22 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748967
Sponsor's protocol ID
CR108139
Other IDs
63871860BAC1001
Status last verified
Oct 2016
First submitted
20 Apr 2016
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ExPEC4V 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 4 Oct 2016. 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 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to follow-up (30 days)). 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 NCT02748967.

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 4 Oct 2016.

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