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| Name | Class |
|---|---|
| Ministry of Health, Russian Federation | OTHER_GOV |
| Institute of Experimental Medicine, Russia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAIV H2N2 vaccine | Experimental | LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart |
|
| Placebo | Placebo Comparator | Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAIV H2N2 | Biological | vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28, Day 56 and Day 112 |
| Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oleg I Kiselev, Ph.D. | Research Institute of Influenza | Principal Investigator |
| Jorge E Flores, MD, Ph.D. | PATH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Influenza | Saint Petersburg | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36146847 | Derived | Rak A, Donina S, Zabrodskaya Y, Rudenko L, Isakova-Sivak I. Cross-Reactivity of SARS-CoV-2 Nucleocapsid-Binding Antibodies and Its Implication for COVID-19 Serology Tests. Viruses. 2022 Sep 14;14(9):2041. doi: 10.3390/v14092041. | |
| 26432909 | Derived | Kiseleva I, Dubrovina I, Fedorova E, Larionova N, Isakova-Sivak I, Bazhenova E, Pisareva M, Kuznetsova V, Flores J, Rudenko L. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses. Vaccine. 2015 Dec 8;33(49):7008-14. doi: 10.1016/j.vaccine.2015.09.050. Epub 2015 Oct 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LAIV H2N2 Vaccine | LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28 |
| FG001 | Placebo | Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally. Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Received Vaccination 1 |
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| Received Vaccination 2 |
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| Completed Study (Day 112) |
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| ID | Title | Description |
|---|---|---|
| BG000 | LAIV H2N2 Vaccine | LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 2 hours |
|
6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LAIV H2N2 Vaccine | LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear congestion | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Other | placebo delivered intranasally. .25cc to each nostril at day 0 and day 28 |
|
| 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. | 7 days following each vaccination |
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. |
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Days 1-6 and Days 29-34 |
| NOT COMPLETED |
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| NOT COMPLETED |
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Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally. Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Count of Participants | Participants | 7 days |
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| Primary | 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. | Posted | Count of Participants | Participants | 7 days |
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| Primary | 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. | Posted | Count of Participants | Participants | 7 days following each vaccination |
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| Primary | 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. | Posted | Count of Participants | Participants | 7 days following each vaccination |
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| Secondary | 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. | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28, Day 56 and Day 112 |
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| Secondary | 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. | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28, Day 56 and Day 112 |
|
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| Secondary | 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). | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28, Day 56 and Day 112 |
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| Secondary | 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). | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28, Day 56 and Day 112 |
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| Secondary | 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. | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28 and Day 56 |
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| Secondary | 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. | Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data. | Posted | Count of Participants | Participants | Day 28 and Day 56 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Days 0-6 and Days 28-34 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Days 0-6 and Days 28-34 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Days 0-6 and Days 28-34 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Days 1-6 and Days 29-34 |
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| 0 |
| 28 |
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| 28 |
| 26 |
| 28 |
| EG001 | Placebo | Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally. Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28 | 0 | 10 | 0 | 10 | 9 | 10 |
| Fatigue | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Periodontitis | Infections and infestations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood bicarbonate increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Blood calcium increased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Blood glucose increased | Investigations | Systematic Assessment |
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| Blood urea increased | Investigations | Systematic Assessment |
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| Eosinophil count increased | Investigations | Systematic Assessment |
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| Haemoglobin increased | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Lymphocyte count increased | Investigations | Systematic Assessment |
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| Mean cell haemoglobin concentration increased | Investigations | Systematic Assessment |
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| Monocyte count increased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Neutrophil count increased | Investigations | Systematic Assessment |
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| Protein total decreased | Investigations | Systematic Assessment |
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| Red blood cell count decreased | Investigations | Systematic Assessment |
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| Red blood cell count increased | Investigations | Systematic Assessment |
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| Red blood cell sedimentation rate increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Headache | Investigations | Systematic Assessment |
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| Nasal congestion | Investigations | Systematic Assessment |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Any solicited local reaction |
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| Any solicited systemic reaction |
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| Any solicited local reaction |
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| Any solicited systemic reaction |
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| Related to vaccination |
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| Related to vaccination |
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