A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
NCT ID: NCT04036526
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2019-06-04
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study contains three periods: screening, inpatient hospitalization and follow-up.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 Drop method
Group 1 will receive vaccine/placebo by drop method.
Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Placebo
Placebo
Group 2 Nasal actuator
Group 2 will receive vaccine/placebo with nasal actuator.
Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vaccine GamLPV
live intranasal vaccine for whooping cough prevention
Placebo
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marina Rusanova
Role: PRINCIPAL_INVESTIGATOR
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Marina Rusanova
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GamLPV-02
Identifier Type: -
Identifier Source: org_study_id