- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635086
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
October 21, 2021 updated by: Themis Bioscience GmbH
Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT9 6 AD
- Celerion Belfast
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is able to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
- Has a negative serum pregnancy test at screening (for female participants)
- Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception
- Has availability during the duration of the trial
Exclusion Criteria:
- Has participated in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period
- Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
- Has a history of drug addiction including alcohol dependence within the last 2 years
- Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine)
- Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period
- Has had a prior receipt of any Chikungunya vaccine
- Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening
- Has had a recent infection within 1 week prior to screening
- Has made blood donations including plasma donations, 90 days prior to screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period
- Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
- Has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
- Has behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Has a history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
- Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant.
- Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants.
- Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of the treatment period
- Has receipt of blood products or immunoglobulins within 120 days prior to the screening visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period
- Has pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
- Has unreliable contraception methods
- Is a person in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Two MV-CHIK lyophilized low dose
Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28.
|
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Experimental: Group B: Two MV-CHIK liquid frozen low dose
Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28.
|
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
|
Experimental: Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)
Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.
|
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.
|
Experimental: Group D: Two MV-CHIK liquid frozen high dose
Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.
|
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
|
Experimental: Group E: One MV-CHIK liquid frozen high dose/placebo
Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.
|
MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.
Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
Time Frame: 28 days after last vaccination (Up to Day 56)
|
Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50).
Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed.
Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group.
This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI).
P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.
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28 days after last vaccination (Up to Day 56)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Solicited and Unsolicited Adverse Events
Time Frame: Up to Day 56
|
An adverse event (AE) includes any untoward medical occurrence in a participant to whom an IMP has been administered, not necessarily caused by or related to that product.
An AE can therefore be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease temporally associated with the use of an IMP whether or not considered related to the IMP.
The percentage of participants with solicited and unsolicited AEs was assessed.
|
Up to Day 56
|
Percentage of Participants With at Least 1 Serious Adverse Event
Time Frame: Up to Day 56
|
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and consists of a congenital anomaly, birth defect or other important medical events.
As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
Up to Day 56
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Time Frame: Up to Day 365
|
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of antibody response by PRNT50.
These results represent geometric mean titers (titers <10 were set to 5 for protocol-specified analysis).
|
Up to Day 365
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Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity will be determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of subjects.
|
Up to Day 56
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
Time Frame: Up to Day 56
|
Cellular immunogenicity was determined by the evaluation of T cell immune response.
Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs).
PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
|
Up to Day 56
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Time Frame: Up to Day 365
|
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of Chikungunya antibody response by enzyme linked immunosorbent assay (ELISA).
The analysis of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized.
|
Up to Day 365
|
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Time Frame: Up to Day 56
|
Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA.
|
Up to Day 56
|
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
Time Frame: Up to Day 56
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
|
Up to Day 56
|
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
Time Frame: Up to Day 56
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.
|
Up to Day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2018
Primary Completion (Actual)
January 25, 2019
Study Completion (Actual)
November 16, 2019
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
October 22, 2021
Last Update Submitted That Met QC Criteria
October 21, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V184-005
- 2018-000211-25 (EudraCT Number)
- MV-CHIK-205 (Other Identifier: Themisbio)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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