- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04415749
NasoShield in Healthy Adults to Study Safety and Immunogenicity
A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Immunogenicity of NasoShield Administered as One or Two Doses in Different Dosing Positions
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
After being informed about the study and potential risks, all healthy volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1 of 3 treatment groups. Within the treatment group, the participant will be randomized in a double-blind manner in a 5:2 ratio to NasoShield or placebo.
The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29 after qualifying into the study. The position of administration and the amount of time the subject will need to stay in the specified position will depend on the group to which the subject is assigned.
Participants will return to the investigational site for multiple visits through Day 210 (approximately 6 months after the second dose). At each visit, the participant will be asked about interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84107
- JBR Clinical Research
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women 18 to 49 years of age, inclusive
- Good general health status
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
- Negative drug and alcohol screen at Screening and predose on Day 1
- For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
- Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last IP dose
- Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
- Provision of written informed consent
Exclusion Criteria:
- Pregnant, possibly pregnant, or lactating women
- Body mass index > 35.0 kg/m2
- Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
- Daily symptoms
- Daily use of short acting beta 2 agonists
- Use of inhaled steroids or theophylline
- Use of pulse systemic steroids
- Emergency care or hospitalization related to asthma or other chronic lung disease
- Systemic steroids for asthma exacerbation
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
- History of coronary artery disease, arrhythmia, or congestive heart failure
- Clinically significant ECG abnormality
- Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1
- History of anaphylaxis or angioedema
- Known allergy to any of the ingredients in the vaccine formulation
- Known allergy or sensitivity to latex
- History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
- Previous nasal surgery or nasal cauterization
- Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1
- Any symptoms within 24 hours before Day 1 of upper respiratory illness or allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP
- Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
- Immunocompromised individuals, including those who have used corticosteroids(including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
- History of autoimmune or demyelinating disease
- Use of statin medication within 30 days before Day 1 (see list in Section 6.7.1)
- Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
- Receipt of any IP within 30 days before Day 1
- Receipt of any vaccine within 30 days before Day 1
- Receipt of intranasal vaccine within 90 days before Day 1
- Receipt of any licensed or investigational anthrax vaccine in civilian or military life
- Any change in medication for a chronic medical condition within 30 days before Day 1
- Past regular use or current use of intranasal illicit drugs
- Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: NasoShield One Dose in Position 1
NasoShield on Day 1 and saline placebo on Day 29 in position 1 (Group 1)
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Normale Kochsalzlösung
NasoShield is an adenovirus-vectored anthrax vaccine
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Placebo-Komparator: Placebo in Position 1
Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1)
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Normale Kochsalzlösung
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Experimental: NasoShield Two Doses in Position 2
NasoShield on Day 1 and Day 29 in position 2 (Group 2)
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NasoShield is an adenovirus-vectored anthrax vaccine
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Placebo-Komparator: Placebo in Position 2
Saline placebo on Day 1 and Day 29 in position 2 (Group 2)
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Normale Kochsalzlösung
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Experimental: NasoShield Two Doses in Position 3
NasoShield on Day 1 and Day 29 in position 3 (Group 3)
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NasoShield is an adenovirus-vectored anthrax vaccine
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Placebo-Komparator: Placebo in Position 3
Saline placebo on Day 1 and Day 29 in position 3 (Group 3)
|
Normale Kochsalzlösung
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Reactogenicity to evaluate the safety of NasoShield
Zeitfenster: For 7 days after vaccination
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Subjects will record solicited local and systemic events for 7 days after each dose
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For 7 days after vaccination
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Adverse Events (AEs) to evaluate the safety of NasoShield
Zeitfenster: From Day 1 to Day 210
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All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
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From Day 1 to Day 210
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity
Zeitfenster: From Day 1 to Day 210
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Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
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From Day 1 to Day 210
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Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity
Zeitfenster: From Day 1 to Day 210
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From Day 1 to Day 210
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Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response
Zeitfenster: From Day 1 to Day 57
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Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
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From Day 1 to Day 57
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Mitarbeiter und Ermittler
Sponsor
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
Andere Studien-ID-Nummern
- ALT-201-102
- HHSO100201600008C (Andere Zuschuss-/Finanzierungsnummer: BARDA)
Plan für individuelle Teilnehmerdaten (IPD)
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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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