Prophylaxis of Influenza A (H1N1) infection. MedDRA version: 9.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Product Name: GHB11L1
Pharmaceutical Form: Nasal spray*
CAS Number: J07BB03
Current Sponsor code: GHB11L1
Other descriptive name: influenza A/Brisbane/59/2007 (H1N1)-like ?NS1)
Concentration unit: log
Sponsors
AVIR Green Hills Biotechnology Research Development Trade AG
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of the influenza vaccine 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 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 challenge virus (challenge virus shedding) as determined by analysis of the TCID50 using area under the curve (AUC) measurements. | — |
Countries
United Kingdom
Outcome results
None listed