Back to resultsA Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Primary Purpose
Whooping Cough
Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Vaccine GamLPV
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Whooping Cough focused on measuring Bordetella pertussis, Live vaccine, Immunological factors, antibody response, cell immune response, whooping cough
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 to 40 (inclusively);
- Healthy verified diagnosis according to standard clinical, laboratory and instrumental examination methods (no somatic disorder of the gastro-intestinal tract (GIT), liver, kidneys, cardiovascular system (CVS), infectious, hematological diseases, cancers (including if the preliminary standard clinical laboratory tests did not reveal any diseases);
- BMI froim 18 to 30 kg/m2 (inclusively);
- Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
- Signed FactSheet and Informed Consent to Participation in the Study.
- No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
- Specific anti-pertussis IgG ≤ 45 EU/ml
- No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Exclusion Criteria:
- Whooping cough in past medical history
- Vaccination against whooping cough over the past decade
- Any other anti-infective immunization during last year
- Any medical condition (renal diseases, hepatic disorders, haematological malignancies, malignant neoplasms and other diseases) which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
- Clinically significant abnormal laboratory values at the discretion of the investigator
- Positive results of HIV, hepatitis B or C
- Use of narcotic drugs and/or a history of drug/alcohol abuse
- Allergic diseases in medical history (in particular drug reaction and food allergy)
- The subject has donated blood/plasma or suffered from blood loss of at least 450 ml (1 unit of blood) within 6 weeks prior to screening
- Current participation in any other clinical trial
- Inability to adhere to the protocol
- Acute infectious diseases within 4 weeks prior to screening
- Wheezing on the results of peakflowmetry
- Significant ECG changes
- Pregnancy or lactation (for female volunteers)
- Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
- Heart rate less than 60 bpm or more than 90 bpm
- Specific anti-pertussis IgG ≥ 45 EU/ml
- The presence of B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Sites / Locations
- Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1 Drop method
Group 2 Nasal actuator
Arm Description
Group 1 will receive vaccine/placebo by drop method.
Group 2 will receive vaccine/placebo with nasal actuator.
Outcomes
Primary Outcome Measures
methods of applications
selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)
dosing schedules
selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)
Secondary Outcome Measures
specific antibody response to B.pertussis
Evaluation of the antibody response after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of antibody level (IgG and IgA) in blood serum and nasopharyngeal aspirates in healthy human volunteers by ELISA.
cell immune responses to B.pertussis
Evaluation of cell immune response parameters after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of induced INF- γ and IL-17 quantity in PBMC supernatant (by ELISA).
dynamics of bacteria generation in nasopharynx of human volunteers
Evaluation of bacterial load in oropharynx/nasopharynx over time after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (B.pertussis DNA detection by RT-PCR method in nasopharyngeal swabs)
Comparative assessment of immunogenicity
Comparative analysis of GamLPV immunogenicity after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (by antibody response evaluation by ELISA)
Full Information
NCT ID
NCT04036526
First Posted
July 24, 2019
Last Updated
July 29, 2019
Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT04036526
Brief Title
A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Official Title
Randomized Double-blind Placebo-controlled Comparative Research of Potency and Safety of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine, Using Two Dosing Schedules and Methods of Application in Healthy Human Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
May 29, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study should be leaded as a randomized double-blind placebo-controlled comparative research of potency and safety of a GamLPV, a live intranasal Bordetella pertussis vaccine, using two dosing schedules and methods of application in healthy human volunteers.
The study contains three periods: screening, inpatient hospitalization and follow-up.
Detailed Description
Subjects are divided into two groups - 25 volunteers in each group. Group 1 will receive vaccine/placebo by drop method. Group 2 will receive vaccine/placebo with nasal actuator. After 60 days both groups will repeatedly receive the same dose of vaccine/placebo by the same methods of application. In each group there are 5 volunteers given placebo.
Monitoring examination of volunteers is carrying out during 60 days after first and second vaccination.
Each group (25 persons) shall be divided into three cohorts (5, 7 and 13 persons). The arm that will receive the drug/ placebo by the dripping method comprises cohorts 1, 3, and 5, and the arm that will receive the drug using the applicator comprises cohorts 2, 4, and 6. Initially, the first and second cohorts (of 5 volunteers each) will be included into the study, respectively.
The main purpose of this study is selection of methods of applications and dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whooping Cough
Keywords
Bordetella pertussis, Live vaccine, Immunological factors, antibody response, cell immune response, whooping cough
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Present clinical trial is a randomized placebo-controlled study for selection of dosing schedules and application methods of GamLPV, a live intranasal Bordetella pertussis vaccine. The study is blinded for volunteers.
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Drop method
Arm Type
Experimental
Arm Description
Group 1 will receive vaccine/placebo by drop method.
Arm Title
Group 2 Nasal actuator
Arm Type
Experimental
Arm Description
Group 2 will receive vaccine/placebo with nasal actuator.
Intervention Type
Biological
Intervention Name(s)
Vaccine GamLPV
Other Intervention Name(s)
live intranasal Bordetella pertussis vaccine
Intervention Description
live intranasal vaccine for whooping cough prevention
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
methods of applications
Description
selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)
Time Frame
the total Time Frame is 140 days after the vaccination
Title
dosing schedules
Description
selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)
Time Frame
the total Time Frame is 140 days after the vaccination
Secondary Outcome Measure Information:
Title
specific antibody response to B.pertussis
Description
Evaluation of the antibody response after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of antibody level (IgG and IgA) in blood serum and nasopharyngeal aspirates in healthy human volunteers by ELISA.
Time Frame
the total Time Frame is 140 days after the vaccination
Title
cell immune responses to B.pertussis
Description
Evaluation of cell immune response parameters after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of induced INF- γ and IL-17 quantity in PBMC supernatant (by ELISA).
Time Frame
the total Time Frame is 140 days after the vaccination
Title
dynamics of bacteria generation in nasopharynx of human volunteers
Description
Evaluation of bacterial load in oropharynx/nasopharynx over time after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (B.pertussis DNA detection by RT-PCR method in nasopharyngeal swabs)
Time Frame
the total Time Frame is 140 days after the vaccination
Title
Comparative assessment of immunogenicity
Description
Comparative analysis of GamLPV immunogenicity after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (by antibody response evaluation by ELISA)
Time Frame
the total Time Frame is 140 days after the vaccination
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 to 40 (inclusively);
Healthy verified diagnosis according to standard clinical, laboratory and instrumental examination methods (no somatic disorder of the gastro-intestinal tract (GIT), liver, kidneys, cardiovascular system (CVS), infectious, hematological diseases, cancers (including if the preliminary standard clinical laboratory tests did not reveal any diseases);
BMI froim 18 to 30 kg/m2 (inclusively);
Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
Signed FactSheet and Informed Consent to Participation in the Study.
No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
Specific anti-pertussis IgG ≤ 45 EU/ml
No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Exclusion Criteria:
Whooping cough in past medical history
Vaccination against whooping cough over the past decade
Any other anti-infective immunization during last year
Any medical condition (renal diseases, hepatic disorders, haematological malignancies, malignant neoplasms and other diseases) which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
Clinically significant abnormal laboratory values at the discretion of the investigator
Positive results of HIV, hepatitis B or C
Use of narcotic drugs and/or a history of drug/alcohol abuse
Allergic diseases in medical history (in particular drug reaction and food allergy)
The subject has donated blood/plasma or suffered from blood loss of at least 450 ml (1 unit of blood) within 6 weeks prior to screening
Current participation in any other clinical trial
Inability to adhere to the protocol
Acute infectious diseases within 4 weeks prior to screening
Wheezing on the results of peakflowmetry
Significant ECG changes
Pregnancy or lactation (for female volunteers)
Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
Heart rate less than 60 bpm or more than 90 bpm
Specific anti-pertussis IgG ≥ 45 EU/ml
The presence of B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gennady Karataev, PhD
Phone
+7 499 193 61 90
Email
karataevgi@rambler.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Rusanova
Organizational Affiliation
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Rusanova
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
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