Clinical trial NCT03500679: A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 100
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/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).


Eligibility criteria: Inclusion Criteria:

* Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
* Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination
* Participant must have a body mass index (BMI) of less than or equal to (\<=)35.0 kilogram per square meter (kg/m\^2)
* Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies
* All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)

Exclusion Criteria:

* Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders
* Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients
* Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy
* Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy
* Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome)
* Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Primary outcomes:
measure: Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination
timeFrame: 14 days after first vaccination (Day 1 to Day 15)
measure: Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination
timeFrame: 14 days after first vaccination (Day 1 to Day 15)
measure: Percentage of Participants With Unsolicited Adverse Events After First Vaccination
timeFrame: 29 days after first vaccination (Day 1 to Day 30)
measure: Number of Participants With Serious Adverse Events (SAEs) After First Vaccination
timeFrame: Up to Day 180
measure: Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1
timeFrame: Day 1
measure: ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15
timeFrame: Day 15
measure: ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
timeFrame: Day 15/Day 1
measure: Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15
timeFrame: Day 15
Secondary outcomes:
measure: Percentage of Participants With Solicited Local Adverse Events After Second Vaccination
timeFrame: 14 days after second vaccination (Day 181 to Day 195)
measure: Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination
timeFrame: 14 days after second vaccination (Day 181 to Day 195)
measure: Percentage of Participants With Unsolicited Adverse Events After Second Vaccination
timeFrame: 29 days after second vaccination (Day 181 to Day 210)
measure: Number of Participants With Serious Adverse Events After Second Vaccination
timeFrame: Day 181 until Day 360
measure: Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15
timeFrame: Days 1 and 15
measure: OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1
timeFrame: Day 15/Day 1
measure: Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15
timeFrame: Day 15
measure: ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195
timeFrame: Days 181 and 195
measure: ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
timeFrame: Day 181/Day 1 and Day 195/Day 1
measure: Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195
timeFrame: Days 181 and 195
measure: OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195
timeFrame: Days 181 and 195
measure: OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1
timeFrame: Day 181/Day 1 and Day 195/Day 1
measure: Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195
timeFrame: Days 181 and 195
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Heartland Clinical Research
state: Kansas
city: Knoxville
country: United States
facility: VGR & NOCCR - Knoxville
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: