Trial | NCT02522754  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    proteosome influenza vaccine ...

  • Study Participants

    174
A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
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.
Study Started
Jan 31
2002
Primary Completion
Jan 31
2004
Study Completion
Jan 31
2004
Last Update
Aug 13
2015
Estimate

Biological Placebo Protesomal Vaccine

Intranasal vaccine Protesomal Vaccine

  • Other names: Placebo

Biological Experimental: Protesomal Vaccine 1 x 30 µg

Experimental: Protesomal Vaccine 1 x 30 µg

Biological Experimental: Protesomal Vaccine 2 x 30 µg

Experimental: Protesomal Vaccine 2 x 30 µg

Biological Experimental: Protesomal Vaccine 2 x 15 µg

Experimental: Protesomal Vaccine 2 x 15 µg

Placebo Placebo Comparator

Placebo

Protesomal Vaccine 1 x 30 µg Experimental

Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg Experimental

Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg Experimental

Protesomal Vaccine 2 x 15 µg

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.
No Results Posted