- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02480101
Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine
19. Juni 2015 aktualisiert von: Oleg Kiselev, Research Institute of Influenza, Russia
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Anhui/2013/61 (H7N9) Influenza Vaccine
This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Phase 1
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
18 Jahre bis 49 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Legal male or female adult 18 through 49 years of age at the enrollment visit.
- Literate and willing to provide written informed consent.
- A signed informed consent.
- Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- Capable and willing to complete diary cards and willing to return for all follow-up visits
- Willing to comply with the rules of the isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by a study physician).
- For females, willing to take reliable birth control measures through day 56.
Exclusion Criteria:
- Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
- Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
- Recent history of frequent nose bleeds (more than 5 within the past year).
- Clinically relevant abnormal paranasal anatomy.
- Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
- Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- Other acute illness at the time of study enrollment.
- Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
- Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment (for corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed, exclusive of nasal.)
- Participation in any previous trial of any H7 or H5 containing influenza vaccine.
- History of bronchial asthma.
- Hypersensitivity and allergy reactions after previous administration of any vaccine.
- History of wheezing after past receipt of any live influenza vaccine.
- Other AE following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza).
- Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
- Seasonal (autumnal) hypersensitivity to the natural environment.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo.
- History of leukemia or any other blood or solid organ cancer.
- History of thrombocytopenic purpura or known bleeding disorder.
- History of seizures.
- Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection.
- Known chronic HBV or HCV infection.
- Known tuberculosis infection or evidence of previous tuberculosis exposure.
- History of chronic alcohol abuse and/or illegal drug use.
- Claustrophobia or sociophobia.
- Pregnancy or lactation (a negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential).
- Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
- Allergic, including anaphylactic, reactions to the introduction of any vaccines in the subject's medical history (not only flu vaccine).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: H7N9 LAIV
H7N9 live influenza vaccine
|
H7N9 live influenza vaccine
Andere Namen:
|
Placebo-Komparator: Placebo
Lyophilized purified allantoic fluid of chicken embryos with stabilizers
|
Lyophilized purified allantoic fluid of chicken embryos with stabilizers
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Immediate reactions
Zeitfenster: 2 hours
|
Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff
|
2 hours
|
Solicited adverse events
Zeitfenster: Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose
|
Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff
|
Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose
|
Changes from baseline in laboratory findings
Zeitfenster: Days 3, 6 and 34
|
Abnormal laboratory findings from blood and urine specimens
|
Days 3, 6 and 34
|
Serious adverse events (SAEs)
Zeitfenster: 4 weeks of receipt of any dose
|
All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56
|
4 weeks of receipt of any dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Immune responses
Zeitfenster: Days 0, 28 and 56
|
Immune responses was parameterized as the proportion of subjects with at least a four-fold rise after each dose from baseline or as the mean titer after each dose in any of the following:
|
Days 0, 28 and 56
|
Virus shedding
Zeitfenster: Days 0-6 after each dose
|
Virus shedding with virus detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs at any time point (at day of vaccination and daily during hospitalization).
|
Days 0-6 after each dose
|
Virus stability
Zeitfenster: Days 0-6 after each dose
|
Virus stability (virus detected and sequenced after inoculation into chicken eggs)
|
Days 0-6 after each dose
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cellular immune responses (cytokine and T-cell)
Zeitfenster: Days 0, 28 and 56
|
Cellular immune responses (cytokine and T-cell) was measured using isolated peripheral blood mononuclear cells (PBMCs) tested by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) assay.
|
Days 0, 28 and 56
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Larisa G Rudenko, MD PhD DSc, Institute of Experimental Medicine
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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. Oktober 2014
Primärer Abschluss (Tatsächlich)
1. Dezember 2014
Studienabschluss (Tatsächlich)
1. April 2015
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2015
Zuerst gepostet (Schätzen)
24. Juni 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
24. Juni 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Juni 2015
Zuletzt verifiziert
1. Juni 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LAIV-H7N9-01
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