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Development of an Intranasal Proteosome Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02522754
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
R Lambkin-Williams, Hvivo

Tracking Information
First Submitted Date  ICMJE July 28, 2015
First Posted Date  ICMJE August 13, 2015
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE January 2002
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
Reduction in Influenza Like Illness in those with laboratory confirmed influenza [ Time Frame: Within the duration of infection, approx 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of an Intranasal Proteosome Influenza Vaccine
Official Title  ICMJE Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Placebo Protesomal Vaccine
    Intranasal vaccine Protesomal Vaccine
    Other Name: Placebo
  • Biological: Experimental: Protesomal Vaccine 1 x 30 µg
    Experimental: Protesomal Vaccine 1 x 30 µg
  • Biological: Experimental: Protesomal Vaccine 2 x 30 µg
    Experimental: Protesomal Vaccine 2 x 30 µg
  • Biological: Experimental: Protesomal Vaccine 2 x 15 µg
    Experimental: Protesomal Vaccine 2 x 15 µg
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: Placebo Protesomal Vaccine
  • Experimental: Protesomal Vaccine 1 x 30 µg
    Protesomal Vaccine 1 x 30 µg
    Intervention: Biological: Experimental: Protesomal Vaccine 1 x 30 µg
  • Experimental: Protesomal Vaccine 2 x 30 µg
    Protesomal Vaccine 2 x 30 µg
    Intervention: Biological: Experimental: Protesomal Vaccine 2 x 30 µg
  • Experimental: Protesomal Vaccine 2 x 15 µg
    Protesomal Vaccine 2 x 15 µg
    Intervention: Biological: Experimental: Protesomal Vaccine 2 x 15 µg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2015)
174
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02522754
Other Study ID Numbers  ICMJE IDB 004 IDB 005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R Lambkin-Williams, Hvivo
Study Sponsor  ICMJE Hvivo
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Rob Lambkin-Williams, PhD PI
PRS Account Hvivo
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP