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| Name | Class |
|---|---|
| Microgen | OTHER |
| Institute of Experimental Medicine, Russia | OTHER |
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To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAIV H5N2 | Experimental | Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally |
|
| Placebo | Placebo Comparator | two doses of placebo solution intranasal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAIV H5N2 | Biological | 2 doses provided intranasally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events by Severity | Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) | Defined as a four-fold or greater antibody rise in titer from pre-vaccination level. HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols. | 28 days (Dose 1) and 56 days (Dose 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Influenza | Saint Petersburg | 197376 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26296497 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | LAIV H5N2 | Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally |
| FG001 | Placebo | two doses of placebo solution provided intranasally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose 1 |
| |||||||||||||
| Dose 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LAIV H5N2 | Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally |
| BG001 | Placebo | two doses of placebo solution intranasal |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Adverse Events by Severity | Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity | All participants that received either a vaccine or placebo, by dose | Posted | Count of Participants | Participants | 6 days |
|
Within 7 days of administration of dose
Definition of adverse event does not differ from clinicaltrials.gov.
Adverse 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 and urine specimens collected on Days 6 and 34.
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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 | Dose 1: Vaccine | Received dose 1 of vaccine | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
Study was completed as expected.
| 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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| Placebo | Other | 2 doses of placebo provided intranasally |
|
| Number/Percentage of Subjects With Serum Neutralizing Antibodies |
Defined as a four-fold or greater antibody rise in titer from pre-vaccination level. Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK). |
| 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA) | IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2 | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG) | Determined using ELISA using whole purified H5N2. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects With Seroconversion for Secretory IgA | IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2 | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects With Seroconversion for IgA in Saliva | IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose | Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study. | 6 days post-vaccination |
| Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose | Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination). | 6 days post-vaccination |
| Geometric Mean Titers for Serum HAI Antibodies | Geometric mean titers for serum hemagglutination inhibition antibodies | 0 days, 28 days (Dose 1) and 56 days (Dose 2) |
| Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies | Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay | 0 days, 28 days (Dose 1) and 56 days (Dose 2) |
| 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | 28 days (Dose 1) and 56 days (Dose 2) |
| Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | 28 days (Dose 1) and 56 days (Dose 2) |
| Rudenko L, Kiseleva I, Stukova M, Erofeeva M, Naykhin A, Donina S, Larionova N, Pisareva M, Krivitskaya V, Flores J; Russian LAIV Trial Study Group. Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: results from a placebo-controlled, randomized double-blind phase I study. Vaccine. 2015 Sep 22;33(39):5110-7. doi: 10.1016/j.vaccine.2015.08.019. Epub 2015 Aug 19. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Received Dose 2 of vaccine
| OG003 | Dose 2: Placebo | Received Dose 2 of placebo |
|
|
| Secondary | Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) | Defined as a four-fold or greater antibody rise in titer from pre-vaccination level. HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols. | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Subjects With Serum Neutralizing Antibodies | Defined as a four-fold or greater antibody rise in titer from pre-vaccination level. Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK). | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA) | IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2 | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG) | Determined using ELISA using whole purified H5N2. | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Subjects With Seroconversion for Secretory IgA | IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2 | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Subjects With Seroconversion for IgA in Saliva | IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2. | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose | Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study. | Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 6 days post-vaccination |
|
|
|
| Secondary | Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose | Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination). | Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 6 days post-vaccination |
|
|
|
| Secondary | Geometric Mean Titers for Serum HAI Antibodies | Geometric mean titers for serum hemagglutination inhibition antibodies | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Geometric Mean | 95% Confidence Interval | titer | 0 days, 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Secondary | Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies | Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Geometric Mean | 95% Confidence Interval | titer | 0 days, 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response. | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response. | Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| Other Pre-specified | Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses | Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells. An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response. | Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured | Posted | Count of Participants | Participants | 28 days (Dose 1) and 56 days (Dose 2) |
|
|
|
| 30 |
| 0 |
| 30 |
| 21 |
| 30 |
| EG001 | Dose 1: Placebo | Received Dose 1 of Placebo | 0 | 10 | 0 | 10 | 8 | 30 |
| EG002 | Dose 2: Vaccine | Received Dose 2 of vaccine | 0 | 29 | 0 | 29 | 25 | 30 |
| EG003 | Dose 2: Placebo | Received Dose 2 of placebo | 0 | 10 | 0 | 10 | 8 | 10 |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Alkaline Phopsphatase Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Bicarbonate Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Calcium Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemoglobin Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Lymphocyte Count Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Monocyte Count Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Red Blood Cell Count Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematocrit Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Mean Cell Haemoglobin Concentraion Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Mean Cell Volume Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Mean Platelet Volume Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Protein Total Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Red Blood Cell Sedimentation Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| No seroconversion |
|
| No seroconversion |
|
| No seroconversion |
|
| No seroconversion |
|
| No seroconversion |
|
| No seroconversion |
|
| No shedding |
|
| No shedding |
|
| After dose 2 |
|
| After dose 2 |
|
| No response |
|
| No response |
|
| No response |
|
| No response |
|
| No response |
|
| No response |
|