A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants
3 octobre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
48
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Fukuoka, Japon
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Expérimental: 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.
Autres noms:
Participant will receive single dose of Placebo on Day 1.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Up to follow-up (30 days)
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Up to follow-up (30 days)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)
Délai: 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
Délai: Up to Day 30
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Up to Day 30
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2016
Achèvement primaire (Réel)
1 août 2016
Achèvement de l'étude (Réel)
1 août 2016
Dates d'inscription aux études
Première soumission
20 avril 2016
Première soumission répondant aux critères de contrôle qualité
20 avril 2016
Première publication (Estimation)
22 avril 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 octobre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 octobre 2016
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CR108139
- 63871860BAC1001 (Autre identifiant: Janssen Pharmaceutical K.K., Japan)
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