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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02522754

Enrollment

174

Registered

2015-08-13

Start date

2002-01-31

Completion date

2004-01-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Brief summary

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

Detailed 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.

Interventions

BIOLOGICALPlacebo Protesomal Vaccine

Intranasal vaccine Protesomal Vaccine

BIOLOGICALExperimental: Protesomal Vaccine 1 x 30 µg

Experimental: Protesomal Vaccine 1 x 30 µg

BIOLOGICALExperimental: Protesomal Vaccine 2 x 30 µg

Experimental: Protesomal Vaccine 2 x 30 µg

BIOLOGICALExperimental: Protesomal Vaccine 2 x 15 µg

Experimental: Protesomal Vaccine 2 x 15 µg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Reduction in Influenza Like Illness in those with laboratory confirmed influenza	Within the duration of infection, approx 10 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026