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

NCT ID: NCT02546960

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-12
• Study Completion Date: 2019-06-21

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ExPEC4V (4 : 4 : 4 : 4)

Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V (4:4:4:4) or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC.

Group Type: EXPERIMENTAL

ExPEC4V (4 : 4 : 4 : 4)

Intervention Type: BIOLOGICAL

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

ExPEC4V (4 : 4 : 4 : 8)

Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses (4 : 4 : 4 : 8/8 : 8 : 8 : 8) of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC.

Group Type: EXPERIMENTAL

ExPEC4V (4 : 4 : 4 : 8)

Intervention Type: BIOLOGICAL

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

ExPEC4V (8 : 8 : 8 : 8)

Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses (4 : 4 : 4 : 8/8 : 8 : 8 : 8) of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC.

Group Type: EXPERIMENTAL

ExPEC4V (8 : 8 : 8 : 8)

Intervention Type: BIOLOGICAL

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

ExPEC4V (8 : 8 : 8 : 16)

Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses (8 : 8 : 8 : 16/16 : 16 : 16 : 16) of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC.

Group Type: EXPERIMENTAL

ExPEC4V (8 : 8 : 8 : 16)

Intervention Type: BIOLOGICAL

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

ExPEC4V (16 : 16 : 16 : 16)

Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses (8 : 8 : 8 : 16/16 : 16 : 16 : 16) of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC.

Group Type: EXPERIMENTAL

ExPEC4V (16 : 16 : 16 : 16)

Intervention Type: BIOLOGICAL

Participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

Placebo

Participants will be stratified according to their age in 2 groups \>= 18 to \<50 years and \>=50 years. Part 1: Participants will receive matching placebo to ExPEC4V as an intramuscular injection into the deltoid muscle. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe and well tolerated based on the review of safety data through Day 8 by the IDMC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

Interventions

ExPEC4V (4 : 4 : 4 : 4)

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Intervention Type: BIOLOGICAL

ExPEC4V (4 : 4 : 4 : 8)

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Intervention Type: BIOLOGICAL

ExPEC4V (8 : 8 : 8 : 8)

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Intervention Type: BIOLOGICAL

ExPEC4V (8 : 8 : 8 : 16)

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Intervention Type: BIOLOGICAL

ExPEC4V (16 : 16 : 16 : 16)

Participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

Intervention Type: BIOLOGICAL

Placebo

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

Intervention Type: DRUG

Other Intervention Names

JNJ-63871860; JNJ-63871860; JNJ-63871860; JNJ-63871860; JNJ-63871860

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mesa, Arizona, United States

Hollywood, Florida, United States

Leesburg, Florida, United States

Miami, Florida, United States

Boise, Idaho, United States

Wichita, Kansas, United States

Bardstown, Kentucky, United States

Baltimore, Maryland, United States

Saint Paul, Minnesota, United States

Kansas City, Missouri, United States

Las Vegas, Nevada, United States

Cary, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Knoxville, Tennessee, United States

Austin, Texas, United States

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31079947 (View on PubMed)

Other Identifiers

63871860BAC2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR107946

Identifier Type: -

Identifier Source: org_study_id