Development of an Intranasal Proteosome Influenza Vaccine

Hvivo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Biological: Placebo Protesomal Vaccine; Biological: Experimental: Protesomal Vaccine 2 x 30 µg; Biological: Experimental: Protesomal Vaccine 1 x 30 µg; Biological: Experimental: Protesomal Vaccine 2 x 15 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02522754

IDB 004 IDB 005

Details and patient eligibility

About

A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

Full description

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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo Protesomal Vaccine

Protesomal Vaccine 1 x 30 µg

Experimental group

Description:

Protesomal Vaccine 1 x 30 µg

Treatment:

Biological: Experimental: Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg

Experimental group

Description:

Protesomal Vaccine 2 x 30 µg

Treatment:

Biological: Experimental: Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg

Experimental group

Description:

Protesomal Vaccine 2 x 15 µg

Treatment:

Biological: Experimental: Protesomal Vaccine 2 x 15 µg