- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00354861
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
A Phase I, Single-Blind Study to Determine the Safety, Tolerability and Pharmacodynamic Profiles of a Hepatitis B Antigen Combined With IMP321 Versus the Hepatitis B Antigen Alone and a Reference Vaccine in Healthy Young Male Volunteers
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
In each cohort, 8 subjects will receive the hepatitis B antigen (10 µg) with IMP321 at one dose, 2 subjects will receive the reference hepatitis B antigen (10 µg) alone with physiological saline and 2 subjects will receive the commercial vaccine Engerix B® (20 µg).
Engerix B® will be administered intramuscularly. The other treatments will be administered subcutaneously.
The four successive cohorts of volunteers will be:
Cohort A:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (3 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort B:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (10 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with Physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort C:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (30 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
If the tolerability of this cohort is acceptable, the following cohort will be done.
Cohort D:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (100 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
Blood samples will be collected on the morning of days 1, 29, 36, 57 and 85 for pharmacodynamic evaluation.
Monitoring for the occurrence of adverse events (AE), changes in physical examination, vital signs (blood pressure, pulse rate, respiration), electrocardiograms (ECG) and clinical laboratory tests (biochemistry, haematology, urinalysis) will be performed before and after each dose of the study drug to assess safety and tolerability.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75015
- SGS Aster-Cephac
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- able to give a written informed consent ;
- healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years;
- with body mass index (weight/height²) in the range 18 to 30 kg/m²;
- registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
- able to comply with protocol requirements, including overnight stays, blood and urine sample collections as defined in the protocol;
- not previously vaccinated for Hepatitis B.
Exclusion Criteria:
- who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
- with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
- who have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
- who forfeit their freedom by administrative or legal award or who were under guardianship ;
- unwilling to give their informed consent ;
- who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
- who have a history of allergy or intolerance to the study drug ;
- who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
- who are known or suspected alcohol or drug abusers ;
- who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
- who undergo surgery or have donated blood within 1 month prior to the start of the study ;
- who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
- who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
- who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
- who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: EIN
IMP321
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hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
Andere Namen:
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Placebo-Komparator: B
Saline
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hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
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Aktiver Komparator: C
Engerix B
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20 µg hepatitis B antigen absorbed on alum
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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To evaluate clinical and laboratory safety and tolerability profiles
Zeitfenster: 3 months
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3 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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To determine T cell response induction efficacy
Zeitfenster: 3 months
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3 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Didier Chassard, M.D., SGS Aster-Cephac
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Hepatitis, viral, menschlich
- Hepadnaviridae-Infektionen
- DNA-Virusinfektionen
- Hepatitis B
- Hepatitis
- Physiologische Wirkungen von Arzneimitteln
- Immunologische Faktoren
- Adjuvantien, Immunologische
- Aluminiumsulfat
Andere Studien-ID-Nummern
- P002
- Aster-P020256
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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