A Phase II Prospective, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Influenza Vaccine GHB11L1 Administered Intranasally Against a Controlled Influenza Virus Challenge in Healthy Adults.

• Conditions: Prophylaxis of Influenza A (H1N1) infection.; MedDRA version: 9.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2009-011529-15-GB
• Lead Sponsor: AVIR Green Hills Biotechnology Research Development Trade AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Male subjects aged 18 to 45 years.
2. In general good health determined by a screening evaluation =45 days prior to
double-blind IMP administration and on the day of double-blind IMP administration
3. Males should be willing to use a reliable form of contraception approved by the
Investigator (use of a condom plus spermicide, or a female partner fulfilling the
following criteria: hysterectomy or bilateral tubal ligation, oral or implanted
contraceptive use, intrauterine device or barrier method plus spermicide) from
immunisation phase baseline (Day -28±2) until 28 (±2) days after the influenza
challenge
4. Negative human immunodeficiency virus (HIV), hepatitis B and C antibody screen
5. Negative drugs of abuse, alcohol and nicotine screen
6. Seronegative for influenza A/Brisbane/59/07(H1N1) (antibody titres <1:10 detected in HAI assay).
7. Have not been vaccinated for influenza virus in 2006/2007 and/or later seasons or
had a known influenza infection in the current or latest season.
8. Give written informed consent to participate after reading the Consent Form and
after having adequate opportunity to discuss the study with an Investigator or
qualified deputy.
9. Willing and able to communicate with the Investigator and understand the
requirements of the study, including willingness to enter and remain in quarantine
until free of influenza infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A complete list of exclusion criteria is given in the respective clinical study protocol:

1. Presence or evidence of significant acute or chronic, uncontrolled medical or
psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated
for =3 months e.g. mild hypertension well-controlled with medication, may be
enrolled – provided the condition and its therapy are known not to be associated with an immunocompromised state or increased risks of complications of influenza)
2. Health care workers (including doctors, nurses, medical students and allied
healthcare professionals) anticipated to have patient contact within two weeks of
viral challenge. Healthcare workers who volunteer should not work with patients until
14 days after challenge or until their symptoms are fully resolved (whichever is the
longer). In particular, any health care workers who work in units housing severely
immunocompromised patients (e.g. bone marrow transplant units).
3. Presence of household member or close contact (for an additional two weeks after
discharge from the isolation facility) who is: less than 3 years of age; has any known
immunodeficiency; is receiving immunosuppressant medications; is undergoing or
soon to undergo cancer chemotherapy within 28 days of challenge; diagnosed with
emphysema or COPD; elderly residing in a nursing home, suffering from severe lung
disease or medical condition including but not exclusive to the conditions listed in
Section 18.4; or a transplant (bone marrow or solid organ) organ recipient
4. Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant, including blood chemistry, haematology or urinalysis.
5. Venous access inadequate for phlebotomy demands of the study
6. Clinically significant abnormality on ECG
7. Any history during adulthood of asthma, chronic obstructive pulmonary disease
(COPD) or any chronic lung condition of any aetiology
8. Smokers who have smoked at any time in the three months prior to study entry or
have a significant history of any tobacco/cannabis use at any time (tobacco: 10 pack
year history = one box a day for 10 years)
9. Any anatomic or neurologic abnormality impairing the gag reflex or associated with a risk of aspiration, or history suggestive of such a problem, or any clinically relevant abnormal paranasal anatomy
10. Subject is type I or II diabetic
11. History or evidence of autoimmune disease or known impaired immune
responsiveness (of any cause)
12. Receipt of systemic glucocorticoids (in a dose =5 mg prednisone daily or equivalent),antiviral drugs, immunoglobulins (Igs) or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months
13. Presence of any febrile illness or symptoms of upper or lower tract respiratory
infection on the day of double-blind IMP administration (such subjects may be reevaluated for enrolment after resolution of the illness). On Day 0, before challenge,
symptoms of grade 1, mild”, are acceptable
14. Presence of any febrile illness or symptoms of upper viral respiratory infection:
• Existing on the day of challenge or between admission for Influenza challenge and
administration of the challenge inoculum. Such subjects may be re-evaluated for
enrolment after resolution of the illness
• Within 2 weeks prior to challenge or if challenge is set to occur during November,
December, January, February, or March if there are any symptoms suggestive of
viral

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the efficacy of the influenza vaccine<br>GHB11L1 against an influenza virus challenge in comparison to a placebo control group.;Secondary Objective: Secondary objectives are to assess safety and tolerability, local and systemic immune<br>response and pharmacokinetics (vaccine virus shedding) of GHB11L1.;Primary end point(s): The primary endpoint is the efficacy of the vaccine in reduction of viral load of the<br>challenge virus (challenge virus shedding) as determined by analysis of the TCID50 using area under the curve (AUC) measurements.