A Phase I, Open-label, Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal A/California/ H1N1 2009 Influenza Challenge Virus in Healthy Volunteers, Following a Single Intranasal Administration

WCCT Global0 sites35 target enrollmentJanuary 19, 2015

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: WCCT Global
Enrollment: 35
Primary Endpoint: Viral Shedding
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.

Registry

clinicaltrials.gov

Start Date

January 19, 2015

End Date

August 10, 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

WCCT Global

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, as determined by medical history, physical examination, vital signs, echocardiogram, 12-lead ECG, and clinical safety laboratory examinations at baseline, as determined by the Investigator.
•Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by an HAI titer of ≤10 prior to challenge.
•Non-smoker (no smoking within the last year and a history of less than 10 packs per year total) and agree to not use tobacco products during participation in the study.
•Female subjects of childbearing potential must:
•Not be breastfeeding
•Have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1
•Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to administration of the A/California/H1N1 2009 virus until the follow-up visit is performed.
•Use another reliable form of contraception approved by the Investigator (eg, intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) from the time of screening until the follow-up visit is performed.
•Female subjects not of childbearing potential must:
•Be at least 1 year post-menopausal, or

Exclusion Criteria

•Prior receipt of any influenza vaccine within the previous 2 years.
•Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis.
•Abnormal nasal structure including septal deviation and nasal polyps, or surgery to the nose or nasopharynx within 6 months of signing the informed consent form or recent (within the last 6 months) history of frequent or prolonged episodes of epistaxis.
•Suffering from asthma, bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing after age 12 (lasting less than 8 weeks) can be included at the investigator's discretion.
•A female who is pregnant or who is breast feeding
•Diastolic BP, systolic BP or, pulse not consistent with normal vital signs, based on investigator judgment.
•Current use or use of intranasal corticosteroids within the last 30 days prior to the administration of the investigational virus product (Study Day 1).
•Presence of significant uncontrolled medical, neurological or psychiatric illness (acute or chronic) as assessed by the Investigator. This includes, but is not limited to, institution of new surgical or medical treatment for a chronic condition), or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day -1 prior to challenge.
•Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
•Cancer or treatment for cancer, within 5 years, excluding basal cell carcinoma of the skin, which is allowed.