Development of an Intranasal Proteosome Influenza Vaccine

Study Overview
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Brief Summary
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A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

Detailed Description
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A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness. In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with  8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.

Official Title
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Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model

Conditions
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Influenza

Intervention / Treatment
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* Biological: Placebo Protesomal Vaccine
* Biological: Experimental: Protesomal Vaccine 1 x 30 µg
* Biological: Experimental: Protesomal Vaccine 2 x 30 µg
* Biological: Experimental: Protesomal Vaccine 2 x 15 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests. Female subjects were required to provide of a history of reliable contraceptive practice. Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. - Exclusion Criteria:included; asthma, hypersensitivity to mercurials or chicken eggs, anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, * chronic nasopharyngeal complaints, abnormal electrocardiogram (ECG), febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum. Subjects using medication or other products for rhinitis or nasal congestion, Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start. Subjects agreed not to smoke during the quarantine phase.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo Protesomal Vaccine<br>* Intranasal vaccine Protesomal Vaccine<br>* Other names: Placebo;|
| Experimental: Protesomal Vaccine 1 x 30 µg<br>Protesomal Vaccine 1 x 30 µg | Biological: Experimental: Protesomal Vaccine 1 x 30 µg<br>* Experimental: Protesomal Vaccine 1 x 30 µg<br>|
| Experimental: Protesomal Vaccine 2 x 30 µg<br>Protesomal Vaccine 2 x 30 µg | Biological: Experimental: Protesomal Vaccine 2 x 30 µg<br>* Experimental: Protesomal Vaccine 2 x 30 µg<br>|
| Experimental: Protesomal Vaccine 2 x 15 µg<br>Protesomal Vaccine 2 x 15 µg | Biological: Experimental: Protesomal Vaccine 2 x 15 µg<br>* Experimental: Protesomal Vaccine 2 x 15 µg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Influenza Like Illness in those with laboratory confirmed influenza |  | Within the duration of infection, approx 10 days |