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The study contains three periods: screening, inpatient hospitalization and follow-up. And should be leaded as a randomized placebo-controlled study with in chain order enrolled volunteers and dose escalating.
After screening, verifying of inclusion/exclusion criteria and signing of informed consent statement volunteers will be directed in a hospital and hospitalized in individual boxes.
Vaccine (GamLPV) or placebo will be administered to groups of volunteers. Each group includes 12 individuals. The study is dose-escalating, so there will be 3 groups.
Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo.
Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo.
Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
On the third day volunteers will be discharged from hospital. 4 visits will be held during outpatient observation- on 8, 15, 29 and 60 days after administration - for physical examination and laboratory assessment. Beside that it would be suggested to volunteers to extend a deadline of participation in the clinical study until 150-th day.
For each dosing group the consecutive inclusion of volunteers with the intermediate evaluation of the safety parameters is stipulated. The group (12 people) is divided into two parts. Originally the first part (5 volunteers) is included in the study. Randomization will be performed by choosing the envelope with the randomizing number at the day of hospitalization. The volunteer will be given either the investigating laboratory specimen or placebo. The researcher includes in the study the 2nd part of the group (7 people) after the evaluation of the intermediate results of the safety analyses (total blood count, biochemical analysis, urinalysis, general examination of a patient). The researcher compiles the intermediate report with the analysis of the endurance of the investigating dose of the preparation after the evaluation of the intermediate safety results. The criterion of the endurance and the dose safety will be at first the absence of serious undesirable phenomena and clinically important shifts of the laboratory indices connected with the administration of the investigating preparation. The decision about the advisability to continue the study and to pass to the 2nd part of volunteers and (or) to escalate the dose will be made by the "Independent committee for data monitoring (ICDM) for periodical examination of the clinical study, safety data and/or main parameters of the efficacy" as well it must be approved by the Local/Independent Ethical Committee of the Research centerе.
After getting the permission to continue the study the next group will be organized according to the analogous scheme: at first the first group of volunteers and then, after receiving the safety results in a written form, the 2nd group will be included, the decision to pass from the second group to the third will be the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 2,5*10*8 bacteria cells (CFU) |
|
| Group 1 placebo | Placebo Comparator | 3 individuals will get placebo |
|
| Group 2 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 10*9 bacteria cells(CFU) |
|
| Group 2 placebo | Placebo Comparator | 3 individuals will get placebo |
|
| Group 3 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 4*10*9 bacteria cells(CFU) |
|
| Group 3 placebo | Placebo Comparator | 3 individuals will get placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine GamLPV | Biological | live intranasal vaccine for whooping cough prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Evaluation of general safety and tolerability of medicinal product "GamLPV, a live intranasal vaccine for whooping cough prevention" in healthy human volunteers compared to placebo, detection the most frequent from possible adverse events of GamLPV | the total Time Frame is 150 days after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Dose ranging and optimal dose choice | Dose ranging and optimal dose choice for safety and tolerability of medicinal product GamLPV, a live intranasal vaccine for whooping cough prevention" in further clinical trials | the total Time Frame is 150 days after the vaccination |
| specific antibody response to B.pertussis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Rusanova | Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department | Moscow | Russia |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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The study is dose-escalating, so there will be 3 groups. Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo.
Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo.
Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
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| Placebo | Other | Placebo |
|
• To assess specific antibody response to B.pertussis after vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention" |
| the total Time Frame is 150 days after the vaccination |
| dynamics of bacteria generation in nasopharynx of human volunteers | To see if the attenuated B.pertussis bacteria have the ability to colonise the human respiratory tract after vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention" and to assess dynamics of bacteria generation in nasopharynx of human volunteers | the total Time Frame is 150 days after the vaccination |
| the B- and T-cell immune responses to B.pertussis | To assess the B- and T-cell immune responses to B.pertussis in response to vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention" | the total Time Frame is 150 days after the vaccination |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |