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

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Whooping Cough

Interventions

Vaccine GamLPVBIOLOGICAL

live intranasal vaccine for whooping cough prevention

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

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)