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

NCT02748967 | Completed Phase 1

• 2 other identifiers: CR10813963871860BAC1001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy; ExPEC4V; JNJ-63871860; Safety

Outcome Measures

Primary Outcomes (1)

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

  Up to follow-up (30 days)

Secondary Outcomes (2)

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

  Up to Day 30

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

  Up to Day 30

Study Arms (6)

Group 1

EXPERIMENTAL

Participants 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.

Drug: ExPEC4V; Drug: Placebo

Group 2

EXPERIMENTAL

Participants with age \>= 20 to \< 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.

Drug: ExPEC4V; Drug: Placebo

Group 3

EXPERIMENTAL

Participants with age \>= 20 to \< 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.

Drug: ExPEC4V; Drug: Placebo

Group 4

EXPERIMENTAL

Participants 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.

Drug: ExPEC4V; Drug: Placebo

Group 5

EXPERIMENTAL

Participants with age \>= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.

Drug: ExPEC4V; Drug: Placebo

Group 6

EXPERIMENTAL

Participants with age \>= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.

Drug: ExPEC4V; Drug: Placebo

Interventions

ExPEC4V DRUG

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

Also known as: JNJ-63871860

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Placebo DRUG

Participant will receive single dose of Placebo on Day 1.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

JP (1)