Clinical trial NCT04036526: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Whooping Cough
Keywords: Bordetella pertussis
Live vaccine
Immunological factors
antibody response
cell immune response
whooping cough
Lead sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: methods of applications
timeFrame: the total Time Frame is 140 days after the vaccination
measure: dosing schedules
timeFrame: the total Time Frame is 140 days after the vaccination
Secondary outcomes:
measure: specific antibody response to B.pertussis
timeFrame: the total Time Frame is 140 days after the vaccination
measure: cell immune responses to B.pertussis
timeFrame: the total Time Frame is 140 days after the vaccination
measure: dynamics of bacteria generation in nasopharynx of human volunteers
timeFrame: the total Time Frame is 140 days after the vaccination
measure: Comparative assessment of immunogenicity
timeFrame: the total Time Frame is 140 days after the vaccination
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Study officials:
affiliation: Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
name: Marina Rusanova
role: PRINCIPAL_INVESTIGATOR
References: