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



Status:Active, not recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:November 12, 2015
End Date:August 31, 2020

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Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

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).

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 4. 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 4 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 3 years after
the double-blind phase for placebo participants and participants in the selected dose group.
Participants' safety will be monitored throughout the study.

Inclusion Criteria:

- Participant must be in stable health. Participants may have underlying illnesses such
as hypertension, diabetes, ischemic heart disease, 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 is expected to remain stable for the duration of
the study

- Participant must meet the protocol defined laboratory criteria within 12 days before
Day 1

- Participant must be able to attend all scheduled visits and to comply with all study
procedures

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

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

Exclusion Criteria:

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

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

- Participant has a serious chronic disorder, including severe chronic obstructive
pulmonary disease or clinically significant congestive heart failure, requirement for
supplemental oxygen, end stage renal disease with or without dialysis, clinically
unstable cardiac disease, or has any condition for which, in the opinion of the
investigator, participation would not be in the best interest of the subject (example
compromise the well-being) or that could prevent, limit, or confound the
protocol-specified assessments

- 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 known or suspected congenital or acquired immunodeficiency (including
leukemia, HIV seropositivity), has received immunosuppressive therapy (such as
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 and
hepatitis C antibody, respectively
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