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Development of an Intranasal Proteosome Influenza Vaccine

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Placebo Protesomal Vaccine

Experimental: Protesomal Vaccine 1 x 30 µg

Experimental: Protesomal Vaccine 2 x 30 µg

Experimental: Protesomal Vaccine 2 x 15 µg

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg

Arm Description

Placebo

Protesomal Vaccine 1 x 30 µg

Protesomal Vaccine 2 x 30 µg

Protesomal Vaccine 2 x 15 µg

Outcomes

Primary Outcome Measures

Reduction in Influenza Like Illness in those with laboratory confirmed influenza

Secondary Outcome Measures

Full Information

NCT ID

NCT02522754

First Posted

July 28, 2015

Last Updated

August 12, 2015

Sponsor

Hvivo

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02522754

Brief Title

Development of an Intranasal Proteosome Influenza Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

January 2002 (undefined)

Primary Completion Date

January 2004 (Actual)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvivo

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Protesomal Vaccine 1 x 30 µg

Arm Type

Experimental

Arm Description

Protesomal Vaccine 1 x 30 µg

Arm Title

Protesomal Vaccine 2 x 30 µg

Arm Type

Experimental

Arm Description

Protesomal Vaccine 2 x 30 µg

Arm Title

Protesomal Vaccine 2 x 15 µg

Arm Type

Experimental

Arm Description

Protesomal Vaccine 2 x 15 µg

Intervention Type

Biological

Intervention Name(s)

Placebo Protesomal Vaccine

Other Intervention Name(s)

Placebo

Intervention Description

Intranasal vaccine Protesomal Vaccine

Intervention Type

Biological

Intervention Name(s)

Experimental: Protesomal Vaccine 1 x 30 µg

Intervention Description

Experimental: Protesomal Vaccine 1 x 30 µg

Intervention Type

Biological

Intervention Name(s)

Experimental: Protesomal Vaccine 2 x 30 µg

Intervention Description

Experimental: Protesomal Vaccine 2 x 30 µg

Intervention Type

Biological

Intervention Name(s)

Experimental: Protesomal Vaccine 2 x 15 µg

Intervention Description

Experimental: Protesomal Vaccine 2 x 15 µg

Primary Outcome Measure Information:

Title

Reduction in Influenza Like Illness in those with laboratory confirmed influenza

Time Frame

Within the duration of infection, approx 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rob Lambkin-Williams, PhD

Organizational Affiliation

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

28005959

Citation

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.

Results Reference

derived

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Development of an Intranasal Proteosome Influenza Vaccine

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