NCT02522754

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2002

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

July 28, 2015

Last Update Submit

August 12, 2015

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Reduction in Influenza Like Illness in those with laboratory confirmed influenza

    Within the duration of infection, approx 10 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo Protesomal Vaccine

Protesomal Vaccine 1 x 30 µg

EXPERIMENTAL

Protesomal Vaccine 1 x 30 µg

Biological: Experimental: Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg

EXPERIMENTAL

Protesomal Vaccine 2 x 30 µg

Biological: Experimental: Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg

EXPERIMENTAL

Protesomal Vaccine 2 x 15 µg

Biological: Experimental: Protesomal Vaccine 2 x 15 µg

Interventions

Placebo Protesomal VaccineBIOLOGICAL

Intranasal vaccine Protesomal Vaccine

Also known as: Placebo
Placebo
Experimental: Protesomal Vaccine 1 x 30 µgBIOLOGICAL

Experimental: Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 1 x 30 µg
Experimental: Protesomal Vaccine 2 x 30 µgBIOLOGICAL

Experimental: Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 30 µg
Experimental: Protesomal Vaccine 2 x 15 µgBIOLOGICAL

Experimental: Protesomal Vaccine 2 x 15 µg

Protesomal Vaccine 2 x 15 µg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lambkin-Williams R, Gelder C, Broughton R, Mallett CP, Gilbert AS, Mann A, He D, Oxford JS, Burt D. An Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine Is Safe, Immunogenic & Efficacious in the Human Viral Influenza Challenge Model. Serum IgG & Mucosal IgA Are Important Correlates of Protection against Illness Associated with Infection. PLoS One. 2016 Dec 22;11(12):e0163089. doi: 10.1371/journal.pone.0163089. eCollection 2016.

    PMID: 28005959DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Rob Lambkin-Williams, PhD

    PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Scientist

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 13, 2015

Study Start

January 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

August 13, 2015

Record last verified: 2015-08