Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036526
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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.


Condition or disease Intervention/treatment Phase
Whooping Cough Biological: Vaccine GamLPV Other: Placebo Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 Drop method
Group 1 will receive vaccine/placebo by drop method.
Biological: Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Other Name: live intranasal Bordetella pertussis vaccine

Other: Placebo
Placebo

Experimental: Group 2 Nasal actuator
Group 2 will receive vaccine/placebo with nasal actuator.
Biological: Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Other Name: live intranasal Bordetella pertussis vaccine

Other: Placebo
Placebo




Primary Outcome Measures :
  1. methods of applications [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)

  2. dosing schedules [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)


Secondary Outcome Measures :
  1. specific antibody response to B.pertussis [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    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.

  2. cell immune responses to B.pertussis [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    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).

  3. dynamics of bacteria generation in nasopharynx of human volunteers [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    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)

  4. Comparative assessment of immunogenicity [ Time Frame: the total Time Frame is 140 days after the vaccination ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female aged 18 to 40 (inclusively);
  2. 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);
  3. BMI froim 18 to 30 kg/m2 (inclusively);
  4. Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
  5. Signed FactSheet and Informed Consent to Participation in the Study.
  6. No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
  7. Specific anti-pertussis IgG ≤ 45 EU/ml
  8. No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).

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. Positive results of HIV, hepatitis B or C
  8. Use of narcotic drugs and/or a history of drug/alcohol abuse
  9. Allergic diseases in medical history (in particular drug reaction and food allergy)
  10. 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
  11. Current participation in any other clinical trial
  12. Inability to adhere to the protocol
  13. Acute infectious diseases within 4 weeks prior to screening
  14. Wheezing on the results of peakflowmetry
  15. Significant ECG changes
  16. Pregnancy or lactation (for female volunteers)
  17. Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
  18. Heart rate less than 60 bpm or more than 90 bpm
  19. Specific anti-pertussis IgG ≥ 45 EU/ml
  20. The presence of B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036526


Contacts
Layout table for location contacts
Contact: Gennady Karataev, PhD +7 499 193 61 90 karataevgi@rambler.ru

Locations
Layout table for location information
Russian Federation
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department Recruiting
Moscow, Russian Federation
Contact: Marina Rusanova         
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Investigators
Layout table for investigator information
Principal Investigator: Marina Rusanova Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Layout table for additonal information
Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04036526    
Other Study ID Numbers: GamLPV-02
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
Bordetella pertussis
Live vaccine
Immunological factors
antibody response
cell immune response
whooping cough
Additional relevant MeSH terms:
Layout table for MeSH terms
Whooping Cough
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Vaccines
Immunologic Factors
Physiological Effects of Drugs