Ebola Hemorrhagic FeverNCT02911415
Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi
An observational study of Ebola Hemorrhagic Fever, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus… Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Hemorrhagic Fever
- What is being tested?
- blood sampling collection
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2016to 25 Dec 2017
- Phase
- Observational
- 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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will enroll up to 60 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
Who may be able to join
- Males and females aged 18-56 who had been earlier vaccinated with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
- Written informed consent signed by patients prior to their involvement in the study
Who cannot join
- Absence of the earlier vaccination with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
- Presence of a concomitant illness which could preclude obtaining a venous blood sample or affect the study process: (critical patient's condition, seizures, agitated state, blood loss and shocks of different origin).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation
Saint Petersburg, 194044
About this study
Official title: Open Study of the Duration of Immunity After Vaccination With Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose
The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.
Read the detailed description
This clinical trial is designed as an open study to evaluate the duration of immunity persistence following the administration of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease.
It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure specified in this Protocol. Only those patients who have signed the information consent form for participation in the study and have been informed by physician on the objectives and methods of this project will be involved in the study.
The study consists of a single stage which is designed as a follow-up period to observe volunteers vaccinated in the course of evaluation of safety, reactogenic properties and immunogenicity of product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015. Vaccination will not be made within the present study. Screening of volunteers is not required: the study will involve as many of the volunteers as possible (but not more than 60 subjects) who had been immunized earlier with GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, provided that they have no medical contraindications for blood sampling.
Study Schedule Visit 1 (outpatient): the goal of this visit is to assess whether a patient meets the inclusion/exclusion criteria. All procedures should be carried out upon receipt of the informed consent form signed by patient. The visit will be held 12 months after the vaccination.
Visit 2 (outpatient): 18 months after the vaccination. Visit 3 (outpatient): 24 months after the vaccination. The duration of immunity persistence following product administration will be assessed in healthy volunteers based on the measurements of specific antibody titers.
- by ELISA method 12, 18 and 24 months after the vaccination vs. baseline values;
- in virus neutralization reaction 12 months after the vaccination vs. baseline values.
- Conditions
- Ebola Hemorrhagic Fever
- Being tested
- blood sampling collection
- Keywords
- Ebola, Ebola Virus Vaccines, Haemorrhagic Fever, Ebola Infection, GP protein, Ebola virus
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling collectionProcedure or surgery
It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure and clinical observation specified in this Protocol.
| Study group | Role | What they receive |
|---|---|---|
| the dosage of 0.25 ml | Blood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015. Receives: Procedure: blood sampling collection | |
| the dosage of 0.5 ml | Blood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015 Receives: Procedure: blood sampling collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer:
- using ELISA method 12 months after the vaccination vs. baseline values
Measured: 12 months after the vaccination
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
Measured: 18 months after the vaccination
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer:
- using ELISA method 24 months after the vaccination vs. baseline values
Measured: 24 months after the vaccination
Secondary outcomes (2)
duration of immunity in virus neutralization reaction
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
Measured: 12 months after the vaccination vs. baseline values
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events. To assess product safety by collecting information on adverse events, development of infectious and non-infectious diseases, and on cases where vaccinated volunteers were seeking for medical care during the follow-up period
Measured: 12, 18 and 24 months 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 posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion25 Dec 2017
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Hemorrhagic FeverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- Konstantin Zhdanov, MD, PhD, Principal investigator, Federal State Budget-funded Military Educational Institution of Higher Education "Military Medical Academy named after S. M. Kirov" of Ministry of Defense of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911415
- Sponsor's protocol ID
- 02 - GamEvac-Combi-2016
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2016
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study of the Duration of Immunity After Vaccination With Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose
- ClinicalTrials.gov ID
- NCT02911415
- Acronym / sponsor ID
- 02 - GamEvac-Combi-2016
- Conditions
- Ebola Hemorrhagic Fever
- Keywords
- Ebola, Ebola Virus Vaccines, Haemorrhagic Fever, Ebola Infection, GP protein, Ebola virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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 purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.
Detailed description
This clinical trial is designed as an open study to evaluate the duration of immunity persistence following the administration of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease.
It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure specified in this Protocol. Only those patients who have signed the information consent form for participation in the study and have been informed by physician on the objectives and methods of this project will be involved in the study.
The study consists of a single stage which is designed as a follow-up period to observe volunteers vaccinated in the course of evaluation of safety, reactogenic properties and immunogenicity of product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015. Vaccination will not be made within the present study. Screening of volunteers is not required: the study will involve as many of the volunteers as possible (but not more than 60 subjects) who had been immunized earlier with GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, provided that they have no medical contraindications for blood sampling.
Study Schedule Visit 1 (outpatient): the goal of this visit is to assess whether a patient meets the inclusion/exclusion criteria. All procedures should be carried out upon receipt of the informed consent form signed by patient. The visit will be held 12 months after the vaccination.
Visit 2 (outpatient): 18 months after the vaccination. Visit 3 (outpatient): 24 months after the vaccination. The duration of immunity persistence following product administration will be assessed in healthy volunteers based on the measurements of specific antibody titers.
- by ELISA method 12, 18 and 24 months after the vaccination vs. baseline values;
- in virus neutralization reaction 12 months after the vaccination vs. baseline values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the dosage of 0.25 ml | – | Procedure: blood sampling collectionBlood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015. |
| the dosage of 0.5 ml | – | Procedure: blood sampling collectionBlood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015 |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will enroll up to 60 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
Key inclusion criteria (2 listed)
- Males and females aged 18-56 who had been earlier vaccinated with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
- Written informed consent signed by patients prior to their involvement in the study
Key exclusion criteria (2 listed)
- Absence of the earlier vaccination with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
- Presence of a concomitant illness which could preclude obtaining a venous blood sample or affect the study process: (critical patient's condition, seizures, agitated state, blood loss and shocks of different origin).
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 |
|---|---|---|
| blood sampling collectionIt is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure and clinical observation specified in this Protocol. | Procedure or surgery | the dosage of 0.25 ml, the dosage of 0.5 ml |
Primary outcome
duration of immunity using ELISA method
Time frame: 12 months after the vaccination
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer: - using ELISA method 12 months after the vaccination vs. baseline values
duration of immunity using ELISA method
Time frame: 18 months after the vaccination
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
duration of immunity using ELISA method
Time frame: 24 months after the vaccination
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer: - using ELISA method 24 months after the vaccination vs. baseline values
2 secondary outcomes
duration of immunity in virus neutralization reaction
Time frame: 12 months after the vaccination vs. baseline values
Incidence of Treatment-Emergent Adverse Events
Time frame: 12, 18 and 24 months 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 27 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.
Konstantin Zhdanov, MD, PhD principal investigator
Federal State Budget-funded Military Educational Institution of Higher Education "Military Medical Academy named after S. M. Kirov" of Ministry of Defense of Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Hemorrhagic Fever, 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 2 inclusion and 2 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 27 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
duration of immunity using ELISA method (time frame: 12 months after the vaccination). The study lists 3 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 27 Dec 2017.