Vaccine Adverse Reaction Clinical Trial
Official title:
Reactogenicity, Safety and Immunogenicity of a Live Monovalent А/17/Hong Kong/2017/75108 (H7N9) Influenza Vaccine
This is a single center phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Hong Kong/2017/75108 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | July 3, 2019 |
Est. primary completion date | June 3, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
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 (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 according to anamnesis and/or available medical records. - History of chronic alcohol abuse and/or illegal drug use. - Claustrophobia or sociophobia according to anamnesis and/or available medical records. - 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Research Institute of Influenza, Russia | Institute of Experimental Medicine, Russia, Joint Stock Company Microgen, Russia, World Health Organization |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cellular immune responses (cytokines and T-cells) | Cellular immune responses (cytokines and T-cells) will be measured using isolated peripheral blood mononuclear cells tested by flow cytometry and ELISPOT techniques. | Days 0, 28, and 56 | |
Primary | Number of Participants with Immediate reactions | Proportion of subjects experiencing immediate reactions (related or not related to the study) occuring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff | 2 hours | |
Primary | Number of Participants with Solicited adverse events | Proportion of subjects experiencing adverse events (related or not related to the study) commonly associated with intranasal vaccination (solicited local and systemic reactions) occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. | greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose | |
Primary | Number of Participants with Changes from baseline in laboratory findings and instrumental tests (ECG, echocardiogram, and spirometry) | Proportion of subjects experiencing all other adverse events (including unsolicited events) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. This includes abnormal laboratory findings from blood specimens and urinalysis collected on Days 3, 6, 31 and 34; IgE level data for Days 0, 3, 28, and 56, as well as instrumental test data (ECG, echocardiogram, and spirometry) on the third day after each vaccination. | Days 3, 6, 31 and 34 | |
Primary | Number of Participants with Serious adverse events (SAEs) | Proportion of subjects experiencing all serious adverse events (SAEs) occurring within 4 weeks of receipt of any dose, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card. This includes abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56. | 4 weeks of receipt of any dose | |
Secondary | Number of Participants with Immune responses | 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 antibodies Serum neutralizing antibodies using microneutralization assay Serum immunoglobulin class A (IgA) and class G (IgG) antibodies using enzyme-linked immunosorbent assay (ELISA) Secretory IgA antibodies from the nasal mucosa detected in nasal wick specimens using ELISA Secretory IgA antibodies detected in saliva specimens using ELISA |
Days 0, 3, 28, and 56 | |
Secondary | Number of Participants with Virus shedding at Days 0-6 after each dose | Virus shedding will be parameterized as the proportion of subjects shedding virus [detected by real-time reverse transcriptase polymerase chain reaction (rRTPCR) in nasal or conjunctival swabs] at any time-point. Shedding data will be reported for every subject at every measured time-point. | Days 0-6 after each dose | |
Secondary | Number and name of mutations leading to any loss of attenuation phenotype of the vaccine virus (genetic stability) | The influenza virus will be isolated in chicken embryos from all PCR influenza A positive nasal or conjunctival swabs collected during 6 days after any vaccine dose. Molecular characterization of any shed virus will be reported with sequence details of any loss of attenuation mutations. | Days 0-6 after each dose |
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