- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04439695
Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
A Phase 1, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.
On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.
Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.
Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68134
- Meridian Clinical Research
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
- Have read, understood, and signed the informed consent form (ICF)
- Healthy adult males and females ages 18 to 49 years, inclusive at screening
- Body mass index (BMI) of ≥18 and ≤34 kg/m2 at screening
- Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments
- Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 3 months after the study completion. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- Female subjects of childbearing potential must have a negative urine pregnancy test before vaccination
- Must be able to attend all visits for the duration of the study and comply with all study procedures, including completion of Diary Card according to the study schedule.
Exclusion Criteria
- History of an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
- Individuals with any elevated (Grade 2 or higher) laboratory test assessed as clinically significant by investigator at screening
Individuals with any elevated (Grade 2 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). See below the criteria for excluding subjects with elevated liver enzymes:
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST): >3 × upper limit of normal (ULN)
- Total bilirubin: >2 × ULN
- Alkaline phosphatase (ALP)/gamma-glutamyl transferase (GGT): >2.5 × ULN
- Active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed)
- History of autoimmune or inflammatory disease
- Women currently pregnant, nursing, or planning a pregnancy between enrollment and 181 days after randomization
- History of a previous serious adverse reaction to any influenza vaccine
- History of Guillain-Barré Syndrome
- History of anaphylactic-type reaction to injected vaccines
- Known or suspected hypersensitivity to 1 or more of the components of TAP-V001
- History of illicit drug use or alcohol abuse in the year before screening
- Receipt of any influenza vaccine within 6 months before screening
- Receipt of any vaccine within 1 month before screening
- Acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator)
- Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month before enrollment in this study; or who expect to receive another experimental agent during participation in this study; or who intend to donate blood during the study period.
- Receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
- Individuals who plan to receive another vaccine, including seasonal influenza vaccine, during the entire 6-month study period.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Low Dose KBP-V001
Subjects in this group will receive the low dose of KBP-V001.
|
Low dose of KBP-V001
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Experimental: Intermediate KBP-V001
Subjects in this group will receive the intermediate dose of KBP-V001.
|
Intermediate dose of KBP-V001
|
Experimental: High Dose KBP-V001
Subjects in this group will receive the high dose of KBP-V001.
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High dose of KBP-V001
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Placebo-Komparator: Placebo
Subjects in this group will receive placebo
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Buffered Saline Solution
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Solicited administration site reactions
Zeitfenster: 7 days after vaccination
|
Occurrences of Adverse Events
|
7 days after vaccination
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Solicited systemic events
Zeitfenster: 7 days after vaccination
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Occurrences of Adverse Events
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7 days after vaccination
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Unsolicited Adverse Events
Zeitfenster: 43 days after vaccination
|
Safety Endpoint
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43 days after vaccination
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Number of Serious Adverse Events and Medically Attended Events
Zeitfenster: 181 days after vaccination
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Safety Endpoint
|
181 days after vaccination
|
Vaccine HAI antibody Titers
Zeitfenster: Day 1, 29, 43, 181
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Vaccine HAI antibody Titers for each treatment group
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Day 1, 29, 43, 181
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Brandon Essink, MD, Meridian Clinical Research
- Studienleiter: Hugh Haydon, Kentucky BioProcessing
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KBP-101
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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