Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 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. Identifier: NCT01719783
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : December 26, 2016
Microgen Scientific Industrial Company for Immunobiological Medicines
Institute of Experimental Medicine, Russia
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Influenza Biological: LAIV H5N2 Other: Intransal placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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
2 doses provided intranasally
Other Name: A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine

Placebo Comparator: Placebo
two doses of placebo solution intranasal
Other: Intransal placebo
2 doses of placebo provided intranasally

Primary Outcome Measures :
  1. Safety [ Time Frame: 6 days ]
    Occurrence of participants with adverse events associated with intranasal administration

Secondary Outcome Measures :
  1. Immune responses [ Time Frame: 28 days ]

    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)

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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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 identifier (NCT number): NCT01719783

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PATH Identifier: NCT01719783     History of Changes
Other Study ID Numbers: LAIV-H5N2-01
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: March 2013

Keywords provided by PATH:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs