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Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480101
First Posted: June 24, 2015
Last Update Posted: June 24, 2015
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.
Collaborators:
World Health Organization
Institute of Experimental Medicine, Russia
Information provided by (Responsible Party):
Oleg Kiselev, Research Institute of Influenza, Russia
  Purpose
This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .

Condition Intervention Phase
Influenza Biological: H7N9 live influenza vaccine Biological: Placebo Phase 1

Study Type: Interventional
Study Design: 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/Anhui/2013/61 (H7N9) Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Oleg Kiselev, Research Institute of Influenza, Russia:

Primary Outcome Measures:
  • Immediate reactions [ Time Frame: 2 hours ]
    Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff

  • Solicited adverse events [ Time Frame: Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose ]
    Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff

  • Changes from baseline in laboratory findings [ Time Frame: Days 3, 6 and 34 ]
    Abnormal laboratory findings from blood and urine specimens

  • Serious adverse events (SAEs) [ Time Frame: 4 weeks of receipt of any dose ]
    All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56


Secondary Outcome Measures:
  • Immune responses [ Time Frame: Days 0, 28 and 56 ]

    Immune responses was parameterized as the proportion of subjects with at least a four-fold rise after each dose from baseline or as the mean titer after each dose in any of the following:

    • Serum hemagglutination inhibition (HAI) antibodies
    • Serum neutralizing antibodies
    • Serum immunoglobulin class A (IgA) or immunoglobulin class G (IgG) antibodies measured by enzyme-linked immunosorbent assay (ELISA)
    • Secretory IgA antibodies from the nasal mucosa detected in nasal wick specimens using ELISA
    • Secretory IgA antibodies in saliva specimens using ELISA

  • Virus shedding [ Time Frame: Days 0-6 after each dose ]
    Virus shedding with virus detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs at any time point (at day of vaccination and daily during hospitalization).

  • Virus stability [ Time Frame: Days 0-6 after each dose ]
    Virus stability (virus detected and sequenced after inoculation into chicken eggs)


Other Outcome Measures:
  • Cellular immune responses (cytokine and T-cell) [ Time Frame: Days 0, 28 and 56 ]
    Cellular immune responses (cytokine and T-cell) was measured using isolated peripheral blood mononuclear cells (PBMCs) tested by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) assay.


Enrollment: 40
Study Start Date: October 2014
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H7N9 LAIV
H7N9 live influenza vaccine
Biological: H7N9 live influenza vaccine
H7N9 live influenza vaccine
Other Name: LAIV H7N9
Placebo Comparator: Placebo
Lyophilized purified allantoic fluid of chicken embryos with stabilizers
Biological: Placebo
Lyophilized purified allantoic fluid of chicken embryos with stabilizers

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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.
  • A signed 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 through day 56.

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 (more than 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 H7 or H5 containing influenza vaccine.
  • History of bronchial asthma.
  • Hypersensitivity and allergy reactions after previous administration of any vaccine.
  • History of wheezing after past receipt of any live influenza vaccine.
  • Other AE following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza).
  • 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.
  • Allergic, including anaphylactic, reactions to the introduction of any vaccines in the subject's medical history (not only flu vaccine).
  Contacts and Locations
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): NCT02480101


Sponsors and Collaborators
Research Institute of Influenza, Russia
World Health Organization
Institute of Experimental Medicine, Russia
Investigators
Study Chair: Larisa G Rudenko, MD PhD DSc Institute of Experimental Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oleg Kiselev, Director, Research Institute of Influenza, Russia
ClinicalTrials.gov Identifier: NCT02480101     History of Changes
Other Study ID Numbers: LAIV-H7N9-01
First Submitted: June 16, 2015
First Posted: June 24, 2015
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Oleg Kiselev, Research Institute of Influenza, Russia:
influenza vaccine pandemic

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