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Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine

This study has been completed.
Sponsor:
Collaborators:
Microgen Scientific Industrial Company for Immunobiological Medicines
Institute of Experimental Medicine, Russia
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01719783
First received: October 26, 2012
Last updated: June 27, 2013
Last verified: March 2013
  Purpose

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.


Condition Intervention Phase
Influenza
Biological: LAIV H5N2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    Occurrence of participants with adverse events associated with intranasal administration


Secondary Outcome Measures:
  • Immune responses [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    To describe the post-vaccination immune responses to the study influenza vaccine and virus shedding by the following:

    • Serum hemagglutination-inhibition antibodies
    • Serum neutralizing antibodies using microneutralization assay
    • Serum immunoglobulin class A (IgA) or class G (IgG) antibodies using enzyme-linked immunoassay (EIA)
    • Secretory IgA antibodies from the nasal mucosa detected in nasal wick specimens using EIA
    • Secretory IgA antibodies detected in saliva specimens using EIA
    • Virus shedding with virus detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs or conjunctival swabs or by isolation in chicken embryos at any time-point.
    • Virus infectivity and stability (virus detected and sequenced after inoculation into chicken eggs)


Enrollment: 40
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAIV H5N2
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
Biological: LAIV H5N2
Other Name: A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine
Placebo Comparator: Placebo
two doses of placebo solution intranasal

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Legal male or female adult 18 through 49 years of age at the enrollment visit.
  • Literate and willing to provide written informed consent.
  • Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
  • Capable and willing to complete diary cards and willing to return for all follow-up visits
  • Willing to comply with the rules of the isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by a study physician).
  • For females, willing to take reliable birth control measures throughout the entire period of participation in the study.

Exclusion Criteria:

  • Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
  • Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
  • Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
  • Recent history of frequent nose bleeds (>5 within the past year).
  • Clinically relevant abnormal paranasal anatomy.
  • Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
  • Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
  • Other acute illness at the time of study enrollment.
  • Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
  • Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed, exclusive of nasal.)
  • Participation in any previous trial of any H5 or H7 containing influenza vaccine.
  • History of asthma.
  • Hypersensitivity after previous administration of any influenza vaccine.
  • History of wheezing after past receipt of any live influenza vaccine.
  • Other AE following immunization, at least possibly related to previous receipt of any influenza vaccine.
  • Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
  • Seasonal (autumnal) hypersensitivity to the natural environment.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo.
  • History of leukemia or any other blood or solid organ cancer.
  • History of thrombocytopenic purpura or known bleeding disorder.
  • History of seizures.
  • Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection.
  • Known chronic HBV or HCV infection.
  • Known tuberculosis infection or evidence of previous tuberculosis exposure.
  • History of chronic alcohol abuse and/or illegal drug use.
  • Claustrophobia or sociophobia.
  • Pregnancy or lactation. (A negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential.)
  • Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719783

Locations
Russian Federation
Research Institute of Influenza
St. Petersburg, Russian Federation, 197376
Sponsors and Collaborators
PATH
Microgen Scientific Industrial Company for Immunobiological Medicines
Institute of Experimental Medicine, Russia
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01719783     History of Changes
Other Study ID Numbers: LAIV-H5N2-01
Study First Received: October 26, 2012
Last Updated: June 27, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by PATH:
influenza
vaccine
pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014