A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants
3 ottobre 2016 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
48
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Fukuoka, Giappone
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Sperimentale: 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.
Altri nomi:
Participant will receive single dose of Placebo on Day 1.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Up to follow-up (30 days)
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Up to follow-up (30 days)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)
Lasso di tempo: 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
Lasso di tempo: Up to Day 30
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Up to Day 30
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2016
Completamento primario (Effettivo)
1 agosto 2016
Completamento dello studio (Effettivo)
1 agosto 2016
Date di iscrizione allo studio
Primo inviato
20 aprile 2016
Primo inviato che soddisfa i criteri di controllo qualità
20 aprile 2016
Primo Inserito (Stima)
22 aprile 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
4 ottobre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 ottobre 2016
Ultimo verificato
1 ottobre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CR108139
- 63871860BAC1001 (Altro identificatore: Janssen Pharmaceutical K.K., Japan)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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