This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.
The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza viruses. 40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo. Blood and urine will be collected during the week following each vaccination and before the next vaccination to monitor safety. Blood samples will also be collected at several timepoints to assess the volunteer's immune response to the vaccine. The total duration of the study is 16 weeks for each volunteer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
38
Research Institute of Influenza
Saint Petersburg, Russia
Percentage of Participants With Immediate Reactions
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Time frame: 2 hours
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Adverse events commonly associated with intranasal vaccination 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. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Time frame: 7 days
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Adverse events commonly associated with intranasal vaccination 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. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Time frame: 7 days
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
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Time frame: 7 days following each vaccination
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Time frame: 7 days following each vaccination
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days.
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by microneutralization assay.
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Time frame: Day 28 and Day 56
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Time frame: Day 28 and Day 56
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 1-6 and Days 29-34