A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants
3. oktober 2016 opdateret af: Janssen Pharmaceutical K.K.
Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 1 double-blind (neither the Investigator nor the participant know the treatment), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) parallel group, single center study in healthy Japanese participants aged greater than or equal to [> =] 20 years.
A target of approximately 48 participants will be enrolled that are stratified according to their age in 2 groups: 24 participants > = 20 to less than [<] 50 years of age and 24 participants > = 50 years of age.
Both groups will be randomized to a single vaccination with 1 of the 3 study dose levels of ExPEC4V or placebo (vaccine buffer).
Participants will be enrolled in a dose ascending approach.
Blood samples will be drawn on Days 1 (prevaccination), 15 and 30 for the assessment of immunogenicity.
The study duration per participant will be approximately 38 days (Screening period and postvaccination follow-up included).
Participants' safety will be monitored throughout the study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Fukuoka, Japan
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study
- Participant must be a man or woman greater than or equal to [> =] 20 years of age on the day of signing the ICF
- A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until at least 3 months after study vaccine administration. A male participant must agree not to donate sperm until at least 3 months after study vaccine administration
- Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of less than or equal to [< =] 30.0 kg/m^2
- A male participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner uses occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
- 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 current or a history of autoimmune disease
- Participant has received an investigational drug (including investigational vaccines) within 90 days before vaccination in the study or is currently enrolled in an investigational study
- Participant has received treatment with immunoglobulins or blood products in the 4 months before vaccination in the study or any plans to receive such treatment during the study
- Participant has known or suspected congenital or acquired immunodeficiency (including leukemia, human immunodeficiency virus [HIV] seropositivity), has received immunosuppressive therapy (such as cyclosporine, 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 (HBsAg) and hepatitis C antibody, respectively
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group 1
Participants with age (greater than or equal to [>=] 20 to less than [<] 50 years) will receive single dose of 0.5 milliliter (mL) of ExPEC4V (4:4:4:4) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Eksperimentel: Group 2
Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Eksperimentel: Group 3
Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Eksperimentel: Group 4
Participants with age greater than or equal to [>=] 50 will receive single dose of 0.5 mL of ExPEC4V (4:4:4:4) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Eksperimentel: Group 5
Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Eksperimentel: Group 6
Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Andre navne:
Participant will receive single dose of Placebo on Day 1.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to follow-up (30 days)
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Up to follow-up (30 days)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)
Tidsramme: Up to Day 30
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Up to Day 30
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Antibody Levels Against the ExPEC4V Measured by Opsonophagocytic Killing (OPK) Assay
Tidsramme: Up to Day 30
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Up to Day 30
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2016
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
20. april 2016
Først indsendt, der opfyldte QC-kriterier
20. april 2016
Først opslået (Skøn)
22. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CR108139
- 63871860BAC1001 (Anden identifikator: Janssen Pharmaceutical K.K., Japan)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ExPEC4V
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Janssen Research & Development, LLCAfsluttet
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Janssen Research & Development, LLCAfsluttet
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Janssen Research & Development, LLCAfsluttetEkstraintestinal patogen Escherichia coli-forebyggelseForenede Stater, Frankrig, Belgien, Spanien, Holland