HealthyPhase 2NCT02546960
A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
A Phase 2 study testing ExPEC4V (4 : 4 : 4 : 4), ExPEC4V (4 : 4 : 4 : 8) and ExPEC4V (8 : 8 : 8 : 8) in people with Healthy, run by Janssen Research & Development, LLC at 17 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ExPEC4V (4 : 4 : 4 : 4), ExPEC4V (4 : 4 : 4 : 8) and ExPEC4V (8 : 8 : 8 : 8)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- 17 sitesUnited States
- Study dates
- 12 Nov 2015to 21 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Bardstown, Kentucky
Study site
Boise, Idaho
Study site
Cary, North Carolina
Study site
Cincinnati, Ohio
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Las Vegas, Nevada
Study site
Leesburg, Florida
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
Raleigh, North Carolina
Study site
Saint Paul, Minnesota
Study site
Wichita, Kansas
About this study
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
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).
Read the 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
- Being tested
- ExPEC4V (4 : 4 : 4 : 4), ExPEC4V (4 : 4 : 4 : 8), ExPEC4V (8 : 8 : 8 : 8), ExPEC4V (8 : 8 : 8 : 16), ExPEC4V (16 : 16 : 16 : 16)
- Keywords
- Healthy, JNJ-63871860, ExPEC4V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExPEC4V (4 : 4 : 4 : 4)Biological
Also called JNJ-63871860
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.
ExPEC4V (4 : 4 : 4 : 8)Biological
Also called JNJ-63871860
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.
ExPEC4V (8 : 8 : 8 : 8)Biological
Also called JNJ-63871860
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.
ExPEC4V (8 : 8 : 8 : 16)Biological
Also called JNJ-63871860
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.
ExPEC4V (16 : 16 : 16 : 16)Biological
Also called JNJ-63871860
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.
PlaceboDrug
Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to Day 8
Number of Participants with Unsolicited AEs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Year 2 and 3
Secondary outcomes (5)
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.
Measured: Day 15
Correlation Between ELISA (total antibody) and OPK (functional antibody) Serum Titers
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 30, 180, and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start12 Nov 2015
- Primary completion12 Sep 2016
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546960
- Sponsor's protocol ID
- CR107946
- Other IDs
- 63871860BAC2001
- Status last verified
- Apr 2020
- First submitted
- 9 Sep 2015
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31079947
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02546960
- Acronym / sponsor ID
- CR107946
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-63871860, ExPEC4V
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ExPEC4V (4 : 4 : 4 : 4) | Experimental | Biological: ExPEC4V (4 : 4 : 4 : 4), Drug: PlaceboParticipants 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. |
| ExPEC4V (4 : 4 : 4 : 8) | Experimental | Biological: ExPEC4V (4 : 4 : 4 : 8), Drug: PlaceboParticipants 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. |
| ExPEC4V (8 : 8 : 8 : 8) | Experimental | Biological: ExPEC4V (8 : 8 : 8 : 8), Drug: PlaceboParticipants 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. |
| ExPEC4V (8 : 8 : 8 : 16) | Experimental | Biological: ExPEC4V (8 : 8 : 8 : 16), Drug: PlaceboParticipants 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. |
| ExPEC4V (16 : 16 : 16 : 16) | Experimental | Biological: ExPEC4V (16 : 16 : 16 : 16), Drug: PlaceboParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExPEC4V (4 : 4 : 4 : 4)Also: JNJ-63871860Participants 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. | Biological | ExPEC4V (4 : 4 : 4 : 4) |
| ExPEC4V (4 : 4 : 4 : 8)Also: JNJ-63871860Participants 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. | Biological | ExPEC4V (4 : 4 : 4 : 8) |
| ExPEC4V (8 : 8 : 8 : 8)Also: JNJ-63871860Participants 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. | Biological | ExPEC4V (8 : 8 : 8 : 8) |
| ExPEC4V (8 : 8 : 8 : 16)Also: JNJ-63871860Participants 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. | Biological | ExPEC4V (8 : 8 : 8 : 16) |
| ExPEC4V (16 : 16 : 16 : 16)Also: JNJ-63871860Participants 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. | Biological | ExPEC4V (16 : 16 : 16 : 16) |
| PlaceboParticipants will receive matching placebo (Tris-buffered saline) to ExPEC4V. | Drug | 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 |
Primary outcome
Number of Participants with Solicited Local Adverse Events (AEs)
Time frame: up to Day 8
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.
Number of Participants with Solicited Systemic AEs
Time frame: up to Day 8
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.
Number of Participants with Unsolicited AEs
Time frame: Up to Day 30
Number of Participants with Serious Adverse Events (SAE's)
Time frame: Until 360 days post vaccination
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.
Dose-dependent Immunogenicity of ExPEC4V on Day 15 (ELISA)
Time frame: Day 15
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.
Long-Term Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)
Time frame: Year 2 and 3
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.
5 secondary outcomes
Dose-dependent Immunogenicity of ExPEC4V on Day 15 (Opsonophagocytic Killing [OPK] Assay)
Time frame: Day 15
Correlation Between ELISA (total antibody) and OPK (functional antibody) Serum Titers
Time frame: Day 15
Dose-dependent Immunogenicity of ExPEC4V on Day 30 (ELISA)
Time frame: Day 30
Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (ELISA)
Time frame: Day 180 and 360
Immunogenicity of ExPEC4V Dose Selected for Further Clinical Development (OPK)
Time frame: Days 30, 180, and 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 31079947Frenck 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ExPEC4V (4 : 4 : 4 : 4), ExPEC4V (4 : 4 : 4 : 8) and ExPEC4V (8 : 8 : 8 : 8) in people with Healthy, run by Janssen Research & Development, LLC at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local Adverse Events (AEs) (time frame: up to Day 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.