A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants
3. Oktober 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
48
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Fukuoka, Japan
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Experimental: 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.
Andere Namen:
Participant will receive single dose of Placebo on Day 1.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Up to follow-up (30 days)
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Up to follow-up (30 days)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)
Zeitfenster: 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
Zeitfenster: Up to Day 30
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Up to Day 30
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2016
Primärer Abschluss (Tatsächlich)
1. August 2016
Studienabschluss (Tatsächlich)
1. August 2016
Studienanmeldedaten
Zuerst eingereicht
20. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. April 2016
Zuerst gepostet (Schätzen)
22. April 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
4. Oktober 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Oktober 2016
Zuletzt verifiziert
1. Oktober 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CR108139
- 63871860BAC1001 (Andere Kennung: Janssen Pharmaceutical K.K., Japan)
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