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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
H7N9 live influenza vaccine
Lyophilized purified allantoic fluid of chicken embryos with stabilizers
Immediate reactions
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
Time frame: 2 hours
Solicited adverse events
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
Time frame: Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose
Changes from baseline in laboratory findings
Abnormal laboratory findings from blood and urine specimens
Time frame: Days 3, 6 and 34
Serious adverse events (SAEs)
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
Time frame: 4 weeks of receipt of any dose
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 (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
Time frame: Days 0, 28 and 56
Virus shedding
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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).
Time frame: Days 0-6 after each dose
Virus stability
Virus stability (virus detected and sequenced after inoculation into chicken eggs)
Time frame: Days 0-6 after each dose