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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

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Placebo Protesomal Vaccine Biological: Experimental: Protesomal Vaccine 1 x 30 µg Biological: Experimental: Protesomal Vaccine 2 x 30 µg Biological: Experimental: Protesomal Vaccine 2 x 15 µg Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : January 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Biological: Placebo Protesomal Vaccine
Intranasal vaccine Protesomal Vaccine
Other Name: Placebo

Experimental: Protesomal Vaccine 1 x 30 µg
Protesomal Vaccine 1 x 30 µg
Biological: Experimental: Protesomal Vaccine 1 x 30 µg
Experimental: Protesomal Vaccine 1 x 30 µg

Experimental: Protesomal Vaccine 2 x 30 µg
Protesomal Vaccine 2 x 30 µg
Biological: Experimental: Protesomal Vaccine 2 x 30 µg
Experimental: Protesomal Vaccine 2 x 30 µg

Experimental: Protesomal Vaccine 2 x 15 µg
Protesomal Vaccine 2 x 15 µg
Biological: Experimental: Protesomal Vaccine 2 x 15 µg
Experimental: Protesomal Vaccine 2 x 15 µg




Primary Outcome Measures :
  1. Reduction in Influenza Like Illness in those with laboratory confirmed influenza [ Time Frame: Within the duration of infection, approx 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522754


Sponsors and Collaborators
Hvivo
GlaxoSmithKline
Investigators
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Principal Investigator: Rob Lambkin-Williams, PhD PI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: R Lambkin-Williams, Chief Scientist, Hvivo
ClinicalTrials.gov Identifier: NCT02522754    
Other Study ID Numbers: IDB 004 IDB 005
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs