Status:
UNKNOWN
A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions:
Whooping Cough
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
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 sche...
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 gr...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 40 (inclusively);
- 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);
- BMI froim 18 to 30 kg/m2 (inclusively);
- Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
- Signed FactSheet and Informed Consent to Participation in the Study.
- No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
- Specific anti-pertussis IgG ≤ 45 EU/ml
- No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Exclusion
- Whooping cough in past medical history
- Vaccination against whooping cough over the past decade
- Any other anti-infective immunization during last year
- 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
- Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
- Clinically significant abnormal laboratory values at the discretion of the investigator
- Positive results of HIV, hepatitis B or C
- Use of narcotic drugs and/or a history of drug/alcohol abuse
- Allergic diseases in medical history (in particular drug reaction and food allergy)
- 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
- Current participation in any other clinical trial
- Inability to adhere to the protocol
- Acute infectious diseases within 4 weeks prior to screening
- Wheezing on the results of peakflowmetry
- Significant ECG changes
- Pregnancy or lactation (for female volunteers)
- Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
- Heart rate less than 60 bpm or more than 90 bpm
- Specific anti-pertussis IgG ≥ 45 EU/ml
- The presence of B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04036526
Start Date
June 4 2019
End Date
September 30 2020
Last Update
July 31 2019
Active Locations (1)
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1
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, Russia