Development of an Intranasal Proteosome Influenza Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine

NCT00677820

Influenza

COMPLETED PHASE4

Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX

NCT03232567

Influenza

COMPLETED PHASE2

Studying Cell Immune Responses to a Live Flu Vaccine in Healthy Adults

NCT01730144

Normal Physiology

COMPLETED

Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

NCT01045564

Influenza

WITHDRAWN PHASE2

Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)

NCT01146119

Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Protesomal Vaccine

Intervention Type BIOLOGICAL

Intranasal vaccine Protesomal Vaccine

Protesomal Vaccine 1 x 30 µg

Group Type EXPERIMENTAL

Experimental: Protesomal Vaccine 1 x 30 µg

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg

Group Type EXPERIMENTAL

Experimental: Protesomal Vaccine 2 x 30 µg

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg

Group Type EXPERIMENTAL

Experimental: Protesomal Vaccine 2 x 15 µg

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 2 x 15 µg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo Protesomal Vaccine

Intranasal vaccine Protesomal Vaccine

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 1 x 30 µg

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 2 x 30 µg

Intervention Type BIOLOGICAL

Experimental: Protesomal Vaccine 2 x 15 µg

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes