Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-03-12 @ 1:16 PM
Study NCT ID:
NCT03137927
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2017-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Organization:
Study Overview
Official Title:
A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine; A Randomized Placebo-controlled Dose-escalating Study of Single-use GamLPV Safety and Tolerability in Healthy Human Volunteers
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 centerŠµ.
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.
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 centerŠµ.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: