NCT04036526

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine GamLPV	live intranasal vaccine for whooping cough prevention
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-06-04
• Primary completion: 2020-05-29
• Completion: 2020-09-30
• First posted: 2019-07-29
• Last updated: 2019-07-31

Locations

1 site across 1 country: Russia