A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
1 other identifier
interventional
36
1 country
1
Brief Summary
The study contains three periods: screening, inpatient hospitalization and follow-up. And should be leaded as a randomized placebo-controlled study with in chain order enrolled volunteers and dose escalating.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
June 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2017
CompletedDecember 28, 2017
April 1, 2017
6 months
April 25, 2017
December 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerability
Evaluation of general safety and tolerability of medicinal product "GamLPV, a live intranasal vaccine for whooping cough prevention" in healthy human volunteers compared to placebo, detection the most frequent from possible adverse events of GamLPV
the total Time Frame is 150 days after the vaccination
Secondary Outcomes (4)
Dose ranging and optimal dose choice
the total Time Frame is 150 days after the vaccination
specific antibody response to B.pertussis
the total Time Frame is 150 days after the vaccination
dynamics of bacteria generation in nasopharynx of human volunteers
the total Time Frame is 150 days after the vaccination
the B- and T-cell immune responses to B.pertussis
the total Time Frame is 150 days after the vaccination
Study Arms (6)
Group 1 Vaccine GamLPV
EXPERIMENTAL9 individuals will be vaccinated intranasally with 2,5\*10\*8 bacteria cells (CFU)
Group 1 placebo
PLACEBO COMPARATOR3 individuals will get placebo
Group 2 Vaccine GamLPV
EXPERIMENTAL9 individuals will be vaccinated intranasally with 10\*9 bacteria cells(CFU)
Group 2 placebo
PLACEBO COMPARATOR3 individuals will get placebo
Group 3 Vaccine GamLPV
EXPERIMENTAL9 individuals will be vaccinated intranasally with 4\*10\*9 bacteria cells(CFU)
Group 3 placebo
PLACEBO COMPARATOR3 individuals will get placebo
Interventions
live intranasal vaccine for whooping cough prevention
Eligibility Criteria
You may qualify if:
- Males and females within the age range from 18 to 40 years
- Health physical condition must be confirmed by routine clinical, laboratory and instrumental methods of diagnosis (absence of gastrointestinal, renal, cardiovascular diseases, hepatic, blood disorders, cancer and infectious diseases)
- Body-weight index within range from 18 to 30 kg\\m2
- Consent for using of reliable contraception (contraception sheath with spermicidal agents) while study and three months after the end of the study
- Signed Participant Information Sheet and informed consent
- Absence of specific antibodies (IgG, IgM, IgA) to Bordetella pertussis (negative ELISA results according to direction for ELISA test-system)
- Absence of Bordetella pertussis DNA in nasopharyngeal swabs (negative PCR results)
You may not qualify if:
- 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
- Use of any medications (in particular herbal medications and dietary supplements) within 30 days after day 0 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 or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0
- Inability to adhere to the protocol
- Acute infectious diseases within 4 weeks prior to screening
- Wheezing on the results of peakflowmetry
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Rusanova
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
May 3, 2017
Study Start
June 13, 2017
Primary Completion
December 19, 2017
Study Completion
December 27, 2017
Last Updated
December 28, 2017
Record last verified: 2017-04