Whooping CoughPhase 1NCT03137927
A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
A Phase 1 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 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. 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
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jun 2017to 27 Dec 2017
- Phase
- Phase 1
- 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
- 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)
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 19Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow
About this study
Official title: A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine; A Randomized Placebo-controlled Dose-escalating Study of Single-use GamLPV Safety and Tolerability in Healthy Human Volunteers
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.
Read the detailed description
After screening, verifying of inclusion/exclusion criteria and signing of informed consent statement volunteers will be directed in a hospital and hospitalized in individual boxes.
Vaccine (GamLPV) or placebo will be administered to groups of volunteers. Each group includes 12 individuals. The study is dose-escalating, so there will be 3 groups.
Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo.
Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo.
Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
On the third day volunteers will be discharged from hospital. 4 visits will be held during outpatient observation- on 8, 15, 29 and 60 days after administration - for physical examination and laboratory assessment. Beside that it would be suggested to volunteers to extend a deadline of participation in the clinical study until 150-th day.
For each dosing group the consecutive inclusion of volunteers with the intermediate evaluation of the safety parameters is stipulated. The group (12 people) is divided into two parts. Originally the first part (5 volunteers) is included in the study. Randomization will be performed by choosing the envelope with the randomizing number at the day of hospitalization. The volunteer will be given either the investigating laboratory specimen or placebo. The researcher includes in the study the 2nd part of the group (7 people) after the evaluation of the intermediate results of the safety analyses (total blood count, biochemical analysis, urinalysis, general examination of a patient). The researcher compiles the intermediate report with the analysis of the endurance of the investigating dose of the preparation after the evaluation of the intermediate safety results. The criterion of the endurance and the dose safety will be at first the absence of serious undesirable phenomena and clinically important shifts of the laboratory indices connected with the administration of the investigating preparation. The decision about the advisability to continue the study and to pass to the 2nd part of volunteers and (or) to escalate the dose will be made by the "Independent committee for data monitoring (ICDM) for periodical examination of the clinical study, safety data and/or main parameters of the efficacy" as well it must be approved by the Local/Independent Ethical Committee of the Research centerе.
After getting the permission to continue the study the next group will be organized according to the analogous scheme: at first the first group of volunteers and then, after receiving the safety results in a written form, the 2nd group will be included, the decision to pass from the second group to the third will be the same.
- Conditions
- Whooping Cough
- Being tested
- Vaccine GamLPV, Placebo
- Keywords
- bordetella pertussis, vaccine, Immunologic Factors, 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 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 2,5*10*8 bacteria cells (CFU) Receives: Biological: Vaccine GamLPV |
| Group 1 placebo | Placebo comparator | 3 individuals will get placebo Receives: Other: Placebo |
| Group 2 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 10*9 bacteria cells(CFU) Receives: Biological: Vaccine GamLPV |
| Group 2 placebo | Placebo comparator | 3 individuals will get placebo Receives: Other: Placebo |
| Group 3 Vaccine GamLPV | Experimental | 9 individuals will be vaccinated intranasally with 4*10*9 bacteria cells(CFU) Receives: Biological: Vaccine GamLPV |
| Group 3 placebo | Placebo comparator | 3 individuals will get placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the total Time Frame is 150 days after the vaccination
Secondary outcomes (4)
Dose ranging and optimal dose choice
Dose ranging and optimal dose choice for safety and tolerability of medicinal product GamLPV, a live intranasal vaccine for whooping cough prevention" in further clinical trials
Measured: the total Time Frame is 150 days after the vaccination
specific antibody response to B.pertussis
- To assess specific antibody response to B.pertussis after vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention"
Measured: the total Time Frame is 150 days after the vaccination
dynamics of bacteria generation in nasopharynx of human volunteers
To see if the attenuated B.pertussis bacteria have the ability to colonise the human respiratory tract after vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention" and to assess dynamics of bacteria generation in nasopharynx of human volunteers
Measured: the total Time Frame is 150 days after the vaccination
the B- and T-cell immune responses to B.pertussis
To assess the B- and T-cell immune responses to B.pertussis in response to vaccination by "GamLPV, a live intranasal vaccine for whooping cough prevention"
Measured: the total Time Frame is 150 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 posted3 May 2017
- Study start13 Jun 2017
- Primary completion19 Dec 2017
- Study completion27 Dec 2017
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is dose-escalating, so there will be 3 groups. Group 1: 9 individuals will be vaccinated intranasally with 2,5\*108 bacteria (CFU), 3 individuals will get placebo. Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo. Group 3: 9 individuals will be vaccinated intranasally with 4\*109 bacteria cells(CFU), 3 individuals will get placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
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
- NCT03137927
- Sponsor's protocol ID
- GamLPV-01
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 28 Dec 2017
- 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 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine; A Randomized Placebo-controlled Dose-escalating Study of Single-use GamLPV Safety and Tolerability in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT03137927
- Acronym / sponsor ID
- GamLPV-01
- Conditions
- Whooping Cough
- Keywords
- bordetella pertussis, vaccine, Immunologic Factors, whooping cough
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 3 May 2017 (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 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.
Detailed description
After screening, verifying of inclusion/exclusion criteria and signing of informed consent statement volunteers will be directed in a hospital and hospitalized in individual boxes.
Vaccine (GamLPV) or placebo will be administered to groups of volunteers. Each group includes 12 individuals. The study is dose-escalating, so there will be 3 groups.
Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo.
Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo.
Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
On the third day volunteers will be discharged from hospital. 4 visits will be held during outpatient observation- on 8, 15, 29 and 60 days after administration - for physical examination and laboratory assessment. Beside that it would be suggested to volunteers to extend a deadline of participation in the clinical study until 150-th day.
For each dosing group the consecutive inclusion of volunteers with the intermediate evaluation of the safety parameters is stipulated. The group (12 people) is divided into two parts. Originally the first part (5 volunteers) is included in the study. Randomization will be performed by choosing the envelope with the randomizing number at the day of hospitalization. The volunteer will be given either the investigating laboratory specimen or placebo. The researcher includes in the study the 2nd part of the group (7 people) after the evaluation of the intermediate results of the safety analyses (total blood count, biochemical analysis, urinalysis, general examination of a patient). The researcher compiles the intermediate report with the analysis of the endurance of the investigating dose of the preparation after the evaluation of the intermediate safety results. The criterion of the endurance and the dose safety will be at first the absence of serious undesirable phenomena and clinically important shifts of the laboratory indices connected with the administration of the investigating preparation. The decision about the advisability to continue the study and to pass to the 2nd part of volunteers and (or) to escalate the dose will be made by the "Independent committee for data monitoring (ICDM) for periodical examination of the clinical study, safety data and/or main parameters of the efficacy" as well it must be approved by the Local/Independent Ethical Committee of the Research centerе.
After getting the permission to continue the study the next group will be organized according to the analogous scheme: at first the first group of volunteers and then, after receiving the safety results in a written form, the 2nd group will be included, the decision to pass from the second group to the third will be the same.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- The study is dose-escalating, so there will be 3 groups. Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo. Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo. Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Vaccine GamLPV | Experimental | Biological: Vaccine GamLPV9 individuals will be vaccinated intranasally with 2,5*10*8 bacteria cells (CFU) |
| Group 1 placebo | Placebo comparator | Other: Placebo3 individuals will get placebo |
| Group 2 Vaccine GamLPV | Experimental | Biological: Vaccine GamLPV9 individuals will be vaccinated intranasally with 10*9 bacteria cells(CFU) |
| Group 2 placebo | Placebo comparator | Other: Placebo3 individuals will get placebo |
| Group 3 Vaccine GamLPV | Experimental | Biological: Vaccine GamLPV9 individuals will be vaccinated intranasally with 4*10*9 bacteria cells(CFU) |
| Group 3 placebo | Placebo comparator | Other: Placebo3 individuals will get placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 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 Vaccine GamLPV, Group 2 Vaccine GamLPV, Group 3 Vaccine GamLPV |
| PlaceboPlacebo | Other | Group 1 placebo, Group 2 placebo, Group 3 placebo |
Primary outcome
safety and tolerability
Time frame: the total Time Frame is 150 days after the vaccination
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
4 secondary outcomes
Dose ranging and optimal dose choice
Time frame: the total Time Frame is 150 days after the vaccination
specific antibody response to B.pertussis
Time frame: the total Time Frame is 150 days after the vaccination
dynamics of bacteria generation in nasopharynx of human volunteers
Time frame: the total Time Frame is 150 days after the vaccination
the B- and T-cell immune responses to B.pertussis
Time frame: the total Time Frame is 150 days after the vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 28 Dec 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: the total Time Frame is 150 days after the vaccination). 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 28 Dec 2017; AzTrials last refreshed its copy on 2 Nov 2026.