Clinical trial NCT02546960: A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Healthy
JNJ-63871860
ExPEC4V
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Solicited Local Adverse Events (AEs)
timeFrame: up to Day 8
measure: Number of Participants with Solicited Systemic AEs
timeFrame: up to Day 8
measure: Number of Participants with Unsolicited AEs
timeFrame: Up to Day 30
measure: Number of Participants with Serious Adverse Events (SAE's)
timeFrame: Until 360 days post vaccination
measure: Dose-dependent Immunogenicity of ExPEC4V on Day 15 (ELISA)
timeFrame: Day 15
measure: Long-Term Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)
timeFrame: Year 2 and 3
Secondary outcomes:
measure: Dose-dependent Immunogenicity of ExPEC4V on Day 15 (Opsonophagocytic Killing [OPK] Assay)
timeFrame: Day 15
measure: Correlation Between ELISA (total antibody) and OPK (functional antibody) Serum Titers
timeFrame: Day 15
measure: Dose-dependent Immunogenicity of ExPEC4V on Day 30 (ELISA)
timeFrame: Day 30
measure: Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)
timeFrame: Day 180 and 360
measure: Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (OPK)
timeFrame: Days 30, 180, and 360
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Hollywood
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Wichita
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Saint Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
References:
citation: Frenck RW Jr, Ervin J, Chu L, Abbanat D, Spiessens B, Go O, Haazen W, van den Dobbelsteen G, Poolman J, Thoelen S, Ibarra de Palacios P. Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial. Lancet Infect Dis. 2019 Jun;19(6):631-640. doi: 10.1016/S1473-3099(18)30803-X. Epub 2019 May 9.