Whooping CoughPhase 1/2NCT04036526
A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
A Phase 1/2 study testing Vaccine GamLPV in people with Whooping Cough, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Whooping Cough
- What is being tested?
- Vaccine GamLPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 4 Jun 2019to 30 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 20Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow
Marina Rusanova
About this study
Official title: 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 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.
Read the 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
- Being tested
- Vaccine GamLPV, Placebo
- Keywords
- Bordetella pertussis, Live vaccine, Immunological factors, antibody response, cell immune response, whooping cough
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine GamLPVBiological
Also called live intranasal Bordetella pertussis vaccine
live intranasal vaccine for whooping cough prevention
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Drop method | Experimental | Group 1 will receive vaccine/placebo by drop method. Receives: Biological: Vaccine GamLPV; Other: Placebo |
| Group 2 Nasal actuator | Experimental | Group 2 will receive vaccine/placebo with nasal actuator. Receives: Biological: Vaccine GamLPV; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: the total Time Frame is 140 days after the vaccination
dosing schedules
selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)
Measured: the total Time Frame is 140 days after the vaccination
Secondary outcomes (4)
specific antibody response to B.pertussis
Evaluation of the antibody response after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of antibody level (IgG and IgA) in blood serum and nasopharyngeal aspirates in healthy human volunteers by ELISA.
Measured: the total Time Frame is 140 days after the vaccination
cell immune responses to B.pertussis
Evaluation of cell immune response parameters after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method compared to placebo. Detection of induced INF- γ and IL-17 quantity in PBMC supernatant (by ELISA).
Measured: the total Time Frame is 140 days after the vaccination
dynamics of bacteria generation in nasopharynx of human volunteers
Evaluation of bacterial load in oropharynx/nasopharynx over time after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (B.pertussis DNA detection by RT-PCR method in nasopharyngeal swabs)
Measured: the total Time Frame is 140 days after the vaccination
Comparative assessment of immunogenicity
Comparative analysis of GamLPV immunogenicity after single and double intranasal vaccine administration in healthy volunteers with nasal actuator and by drop method (by antibody response evaluation by ELISA)
Measured: the total Time Frame is 140 days after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start4 Jun 2019
- Primary completion29 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Present clinical trial is a randomized placebo-controlled study for selection of dosing schedules and application methods of GamLPV, a live intranasal Bordetella pertussis vaccine. The study is blinded for volunteers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Rusanova, Principal investigator, Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036526
- Sponsor's protocol ID
- GamLPV-02
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04036526
- Acronym / sponsor ID
- GamLPV-02
- Conditions
- Whooping Cough
- Keywords
- Bordetella pertussis, Live vaccine, Immunological factors, antibody response, cell immune response, whooping cough
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 29 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Present clinical trial is a randomized placebo-controlled study for selection of dosing schedules and application methods of GamLPV, a live intranasal Bordetella pertussis vaccine. The study is blinded for volunteers.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Drop method | Experimental | Biological: Vaccine GamLPV, Other: PlaceboGroup 1 will receive vaccine/placebo by drop method. |
| Group 2 Nasal actuator | Experimental | Biological: Vaccine GamLPV, Other: PlaceboGroup 2 will receive vaccine/placebo with nasal actuator. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine GamLPVAlso: live intranasal Bordetella pertussis vaccinelive intranasal vaccine for whooping cough prevention | Biological | Group 1 Drop method, Group 2 Nasal actuator |
| PlaceboPlacebo | Other | Group 1 Drop method, Group 2 Nasal actuator |
Primary outcome
methods of applications
Time frame: the total Time Frame is 140 days after the vaccination
selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)
dosing schedules
Time frame: the total Time Frame is 140 days after the vaccination
selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)
4 secondary outcomes
specific antibody response to B.pertussis
Time frame: the total Time Frame is 140 days after the vaccination
cell immune responses to B.pertussis
Time frame: the total Time Frame is 140 days after the vaccination
dynamics of bacteria generation in nasopharynx of human volunteers
Time frame: the total Time Frame is 140 days after the vaccination
Comparative assessment of immunogenicity
Time frame: the total Time Frame is 140 days after the vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Rusanova principal investigator
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaccine GamLPV in people with Whooping Cough, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gennady Karataev, PhD (+7 499 193 61 90, karataevgi@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
methods of applications (time frame: the total Time Frame is 140 days after the vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.