Development of an Intranasal Proteosome Influenza Vaccine

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522754
• Other study ID #: IDB 004 IDB 005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 28, 2015
• Last updated: August 12, 2015
• Start date: January 2002
• Est. completion date: January 2004

Study information

• Verified date: August 2015
• Source: Hvivo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Placebo Protesomal Vaccine
Intranasal vaccine Protesomal Vaccine
• Experimental: Protesomal Vaccine 1 x 30 µg
Experimental: Protesomal Vaccine 1 x 30 µg
• Experimental: Protesomal Vaccine 2 x 30 µg
Experimental: Protesomal Vaccine 2 x 30 µg
• Experimental: Protesomal Vaccine 2 x 15 µg
Experimental: Protesomal Vaccine 2 x 15 µg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hvivo	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Influenza Like Illness in those with laboratory confirmed influenza		Within the duration of infection, approx 10 days	No