A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine

December 27, 2017 updated by: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females within the age range from 18 to 40 years
  2. Health physical condition must be confirmed by routine clinical, laboratory and instrumental methods of diagnosis (absence of gastrointestinal, renal, cardiovascular diseases, hepatic, blood disorders, cancer and infectious diseases)
  3. Body-weight index within range from 18 to 30 kg\m2
  4. Consent for using of reliable contraception (contraception sheath with spermicidal agents) while study and three months after the end of the study
  5. Signed Participant Information Sheet and informed consent
  6. Absence of specific antibodies (IgG, IgM, IgA) to Bordetella pertussis (negative ELISA results according to direction for ELISA test-system)
  7. Absence of Bordetella pertussis DNA in nasopharyngeal swabs (negative PCR results)

Exclusion Criteria:

  1. Whooping cough in past medical history
  2. Vaccination against whooping cough over the past decade
  3. Any other anti-infective immunization during last year
  4. 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
  5. Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
  6. Clinically significant abnormal laboratory values at the discretion of the investigator
  7. Use of any medications (in particular herbal medications and dietary supplements) within 30 days after day 0 at the discretion of the investigator
  8. Positive results of HIV, hepatitis B or C
  9. Use of narcotic drugs and/or a history of drug/alcohol abuse
  10. Allergic diseases in medical history (in particular drug reaction and food allergy)
  11. 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
  12. Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0
  13. Inability to adhere to the protocol
  14. Acute infectious diseases within 4 weeks prior to screening
  15. Wheezing on the results of peakflowmetry
  16. Significant ECG changes
  17. Pregnancy or lactation (for female volunteers)
  18. Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
  19. Heart rate less than 60 bpm or more than 90 bpm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 2,5*10*8 bacteria cells (CFU)
Biological: Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Other Names:
  • live intranasal Bordetella pertussis vaccine
Placebo Comparator: Group 1 placebo
3 individuals will get placebo
Other: Placebo
Placebo
Experimental: Group 2 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 10*9 bacteria cells(CFU)
Biological: Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Other Names:
  • live intranasal Bordetella pertussis vaccine
Placebo Comparator: Group 2 placebo
3 individuals will get placebo
Other: Placebo
Placebo
Experimental: Group 3 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 4*10*9 bacteria cells(CFU)
Biological: Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Other Names:
  • live intranasal Bordetella pertussis vaccine
Placebo Comparator: Group 3 placebo
3 individuals will get placebo
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety and tolerability
Time Frame: the total Time Frame is 150 days after the vaccination
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose ranging and optimal dose choice
Time Frame: the total Time Frame is 150 days after the vaccination
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
Time Frame: the total Time Frame is 150 days after the vaccination
• 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
Time Frame: the total Time Frame is 150 days after the vaccination
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
Time Frame: the total Time Frame is 150 days after the vaccination
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marina Rusanova, Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GamLPV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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