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

NCT02546960 | Completed Phase 2 DMC

• 2 other identifiers: CR10794663871860BAC2001
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 17

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).

Conditions

Healthy

Keywords

Healthy; JNJ-63871860; ExPEC4V

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Solicited Local Adverse Events (AEs)

  Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the electronic Subject Diary. Solicited Local AEs: Participants will be instructed on how to note occurrences of pain/tenderness, erythema, and induration/swelling at the injection site daily for 8 days postvaccination (day of vaccination and the subsequent 7 days) in the electronic Subject Diary. Participants will be instructed on how to measure (using the ruler supplied) and record erythema and induration.

  up to Day 8

• Number of Participants with Solicited Systemic AEs

  Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the electronic Subject Diary. Solicited Systemic AEs: Participants will be instructed on how to note daily symptoms in the electronic Subject Diary for 8 days post vaccination (day of vaccination and the subsequent 7 days) of the following systemic events: fever, headache, fatigue, malaise, nausea, and myalgia.

  up to Day 8

• Number of Participants with Unsolicited AEs

  Up to Day 30

• Number of Participants with Serious Adverse Events (SAE's)

  An SAE is any adverse event that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  Until 360 days post vaccination

• Dose-dependent Immunogenicity of ExPEC4V on Day 15 (ELISA)

  Dose-dependent immunogenicity will be measured by enzyme-linked immunosorbent assay (ELISA) on day 15 in participants with \>=18 years of age. Immunoglobulin G (IgG) antibody levels elicited by the vaccine will be measured by ELISA.

  Day 15

• Long-Term Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)

  Evaluation of the immunogenicity of a single vaccination with the ExPEC4V dose selected for further clinical development based on the primary analysis, as measured by ELISA.

  Year 2 and 3

Secondary Outcomes (5)

• Dose-dependent Immunogenicity of ExPEC4V on Day 15 (Opsonophagocytic Killing [OPK] Assay)

  Day 15

• Correlation Between ELISA (total antibody) and OPK (functional antibody) Serum Titers

  Day 15

• Dose-dependent Immunogenicity of ExPEC4V on Day 30 (ELISA)

  Day 30

• Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)

  Day 180 and 360

• Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (OPK)

  Days 30, 180, and 360

Study Arms (6)

ExPEC4V (4 : 4 : 4 : 4)

EXPERIMENTAL

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.

Biological: ExPEC4V (4 : 4 : 4 : 4); Drug: Placebo

ExPEC4V (4 : 4 : 4 : 8)

EXPERIMENTAL

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.

Biological: ExPEC4V (4 : 4 : 4 : 8); Drug: Placebo

ExPEC4V (8 : 8 : 8 : 8)

EXPERIMENTAL

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.

Biological: ExPEC4V (8 : 8 : 8 : 8); Drug: Placebo

ExPEC4V (8 : 8 : 8 : 16)

EXPERIMENTAL

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.

Biological: ExPEC4V (8 : 8 : 8 : 16); Drug: Placebo

ExPEC4V (16 : 16 : 16 : 16)

EXPERIMENTAL

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.

Biological: ExPEC4V (16 : 16 : 16 : 16); Drug: Placebo

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ExPEC4V (4 : 4 : 4 : 4) 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.

Also known as: JNJ-63871860

ExPEC4V (4 : 4 : 4 : 4)

ExPEC4V (4 : 4 : 4 : 8) 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.

Also known as: JNJ-63871860

ExPEC4V (4 : 4 : 4 : 8)

ExPEC4V (8 : 8 : 8 : 8) 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.

Also known as: JNJ-63871860

ExPEC4V (8 : 8 : 8 : 8)

ExPEC4V (8 : 8 : 8 : 16) 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.

Also known as: JNJ-63871860

ExPEC4V (8 : 8 : 8 : 16)

ExPEC4V (16 : 16 : 16 : 16) 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.

Also known as: JNJ-63871860

ExPEC4V (16 : 16 : 16 : 16)

Placebo DRUG

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

ExPEC4V (16 : 16 : 16 : 16); ExPEC4V (4 : 4 : 4 : 4); ExPEC4V (4 : 4 : 4 : 8); ExPEC4V (8 : 8 : 8 : 16); ExPEC4V (8 : 8 : 8 : 8); Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (17)

Unknown Facility

Mesa, Arizona, United States

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Hollywood, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Boise, Idaho, United States

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Wichita, Kansas, United States

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Bardstown, Kentucky, United States

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Baltimore, Maryland, United States

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Saint Paul, Minnesota, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Related Publications (1)

• 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.

  PMID: 31079947 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: November 12, 2015
• Primary Completion: September 12, 2016
• Study Completion: June 21, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

US (17)