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| ID | Type | Description | Link |
|---|---|---|---|
| 63871860BAC2001 | Other Identifier | Janssen Research & Development, LLC |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-dependent Immunogenicity of ExPEC4V on Day 15 (Opsonophagocytic Killing [OPK] Assay) | Dose-dependent immunogenicity will be measured by opsonophagocytic killing (OPK) assay on day 15 in participants with >=18 years of age. Specific functional antibacterial antibodies will be measured by OPK. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31079947 | Derived | 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Placebo | Drug | Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V. |
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| 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 |
| Correlation Between ELISA (total antibody) and OPK (functional antibody) Serum Titers |
| Day 15 |
| Dose-dependent Immunogenicity of ExPEC4V on Day 30 (ELISA) | Dose-dependent immunogenicity will be measured by ELISA on day 30 in participants with >=18 years of age. IgG antibody levels elicited by the vaccine will be measured by ELISA. | Day 30 |
| Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA) | The immunogenicity of the ExPEC4V dose selected for further clinical development based on the interim analysis, as measured by ELISA will be evaluated. IgG antibody levels elicited by the vaccine will be measured by ELISA. | Day 180 and 360 |
| Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (OPK) | The immunogenicity of the ExPEC4V dose selected for further clinical development based on the interim analysis, as measured by OPK assay will be evaluated. Specific functional antibacterial antibodies will be measured by OPK. | Days 30, 180, and 360 |
| 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 |