Safety Trial of Live Attenuated Influenza (H7N3) Vaccine

This study has been completed.
Sponsor:
Collaborators:
Russia: Microgen Scientific Industrial Company for Immunobiological Medicines
Russia: Research Institute of Influenza
Russia: Institute of Experimental Medicine
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01511419
First received: January 5, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

The study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.


Condition Intervention Phase
Influenza
Avian Influenza
Biological: live attenuated monovalent A/17/mallard/Netherlands/00/95(H7N3) influenza vaccine
Biological: placebo
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/Mallard/Netherlands/00/95 (H7N3) Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: through four weeks post-dose 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity measure 1 [ Time Frame: four weeks post-dose 2 ] [ Designated as safety issue: No ]
    serum hemagglutination-inhibition antibodies

  • immunogenicity measure 2 [ Time Frame: four weeks post-dose 2 ] [ Designated as safety issue: No ]
    serum neutralizing antibodies using microneutralization assay

  • immunogenicity measure 3 [ Time Frame: four weeks post-dose 2 ] [ Designated as safety issue: No ]
    serum immunoglobulin class A (IgA) antibodies using enzyme-linked immunoassay

  • immunogenicity measure 4 [ Time Frame: four weeks post-dose 2 ] [ Designated as safety issue: No ]
    serum immunoglobulin class G (IgG) antibodies using enzyme-linked immunoassay

  • immunogenicity measure 5 [ Time Frame: four weeks post-dose 2 ] [ Designated as safety issue: No ]
    mucosal IgA antibodies in nasal specimen

  • infectivity [ Time Frame: for one week after vaccination ] [ Designated as safety issue: No ]
    virus shedding detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs or conjunctival swabs or by isolation in chicken embryos

  • viral stability [ Time Frame: for one week after vaccination ] [ Designated as safety issue: No ]
    virus detected in nasal swab specimen and sequenced after inoculation into chicken eggs


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: live attenuated influenza vaccine
Monovalent H7N3 live monovalent influenza vaccine
Biological: live attenuated monovalent A/17/mallard/Netherlands/00/95(H7N3) influenza vaccine
two doses given one month apart
Placebo Comparator: placebo
manufactured placebo based on allantoic fluid of chicken embryos not inoculated with influenza virus
Biological: placebo
manufactured placebo based on allantoic fluid of chicken embryos not inoculated with influenza virus

  Show Detailed Description

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511419

Locations
Russian Federation
Research Institute of Influenza
St Petersburg, Russian Federation, 197376
Sponsors and Collaborators
PATH
Russia: Microgen Scientific Industrial Company for Immunobiological Medicines
Russia: Research Institute of Influenza
Russia: Institute of Experimental Medicine
Investigators
Principal Investigator: Oleg I Kiselev, MD, PhD, DSc Research Institute of Influenza
Study Director: Larisa G Rudenko, MD, PhD, DSc Institute of Experimental Medicine
Study Director: Kathleen M Neuzil, MD, MPH PATH Vaccine Solutions
Study Director: Igor Victorevich Microgen Scientific Industrial Company for immunobiological Medicines
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01511419     History of Changes
Other Study ID Numbers: LAIV-H7N3-01
Study First Received: January 5, 2012
Last Updated: July 10, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by PATH:
Influenza
Vaccine
Pandemic
H7N3

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

ClinicalTrials.gov processed this record on April 15, 2014