A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

Last updated: April 16, 2020
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02546960
CR107946
63871860BAC2001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety, tolerability of different doses of JNJ-63871860 (ExPEC4V) in participants greater than or equal to (>=)18 years of age and to evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be in stable health. Participants may have underlying illnesses suchas hypertension, diabetes, ischemic heart disease, hyperlipoproteinemia, orhypothyroidism, as long as their symptoms/signs are medically controlled. If they areon medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and is expected to remain stable for the duration ofthe study

  • Participant must meet the protocol defined laboratory criteria within 12 days beforeDay 1

  • Participant must be able to attend all scheduled visits and to comply with all studyprocedures

  • Participant must have a body mass index (BMI) of less than or equal to (<=) 35kilogram per square meter (kg/m^2)

  • A woman of childbearing potential must have a negative urine pregnancy test on Day 1before vaccination

Exclusion

Exclusion Criteria:

  • Participant is a woman who is pregnant, breast-feeding, or has a positive urinepregnancy test on Day 1 before vaccination, or is planning to become pregnant 3 monthsafter study vaccine administration or within 3 months after study vaccineadministration, or subject is a man who plans to father a child while enrolled in thisstudy or within 3 months after study vaccine administration

  • Participant has an acute illness, acute infection, or fever (body temperature greaterthan or equal to [>=] 38 degree Celsius)

  • Participant has a serious chronic disorder, including severe chronic obstructivepulmonary disease or clinically significant congestive heart failure, requirement forsupplemental oxygen, end stage renal disease with or without dialysis, clinicallyunstable cardiac disease, or has any condition for which, in the opinion of theinvestigator, participation would not be in the best interest of the subject (examplecompromise the well-being) or that could prevent, limit, or confound theprotocol-specified assessments

  • Participant has a history of neoplastic disease (excluding non-melanoma skin cancerthat was successfully treated) within the past 5 years or a history of anyhematological malignancy

  • Participant has known or suspected congenital or acquired immunodeficiency (includingleukemia, HIV seropositivity), has received immunosuppressive therapy (such asanti-cancer chemotherapy, radiation therapy or cytotoxic drugs), within the preceding 6 months; or long-term systemic corticosteroid therapy [prednisone or equivalent formore than 2 consecutive weeks within the past 3 months]), or has chronic activehepatitis B or hepatitis C infection, documented by hepatitis B surface antigen andhepatitis C antibody, respectively

Study Design

Total Participants: 848
Study Start date:
November 12, 2015
Estimated Completion Date:
June 21, 2019

Study Description

This is a Phase 2, double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group, multicenter (when more than one hospital work on a medical research study) study, with a single-blind, long-term follow-up to Year 3. The study will be split into 2 phases, a double-blind phase with screening (Day -12 to Day 1), Vaccination (Day

  1. and Safety and Immunogenicity Follow-up (Day 1 up to Day 360), and a single-blind long-term follow-up phase thereafter until Year 3 for participants in placebo and two ExPEC4V dose groups selected based on the primary (Day 30) analysis. Participants will be stratified in 2 age groups (>=18 to less than [<] 50 years and >=50 years) and in each dosing group in each stratum randomized to a single vaccination with 1 of 5 doses of ExPEC4V or placebo. The duration of the double-blind phase (from randomization/vaccination) will be approximately 360 days for placebo participants and participants in the dose group selected based on the primary analysis, and approximately 180 days for the participants in the other groups. The duration of the single-blind long-term follow-up phase will be approximately 2 years after the double-blind phase for placebo participants and participants in the selected dose group. Participants' safety will be monitored throughout the study.

Connect with a study center

  • Mesa, Arizona
    United States

    Site Not Available

  • Hollywood, Florida
    United States

    Site Not Available

  • Leesburg, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • empty

    Meridian, Idaho
    United States

    Site Not Available

  • Wichita, Kansas
    United States

    Site Not Available

  • Bardstown, Kentucky
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Saint Paul, Minnesota
    United States

    Site Not Available

  • Kansas City, Missouri
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Cary, North Carolina
    United States

    Site Not Available

  • Raleigh, North Carolina
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Knoxville, Tennessee
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

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