Chikungunya Virus InfectionPhase 2NCT03635086
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
A Phase 2 study testing MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose and MV-CHIK SPS® formulation, low dose in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose and MV-CHIK SPS® formulation, low dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Aug 2018to 16 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Celerion Belfast
Belfast, Northern Ireland, BT9 6 AD
About this study
Official title: 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.
- Conditions
- Chikungunya Virus Infection
- Being tested
- MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose, MV-CHIK SPS® formulation, low dose, MV-CHIK liquid frozen formulation, high dose, Placebo
- Keywords
- Chikungunya fever
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV-CHIK lyophilised formulation, low doseBiological
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.
MV-CHIK liquid frozen formulation, low doseBiological
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.
MV-CHIK SPS® formulation, low doseBiological
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.
MV-CHIK liquid frozen formulation, high doseBiological
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.
PlaceboOther
Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Two MV-CHIK lyophilized low dose | Experimental | Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28. Receives: Biological: MV-CHIK lyophilised formulation, low dose |
| Group B: Two MV-CHIK liquid frozen low dose | Experimental | Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28. Receives: Biological: MV-CHIK liquid frozen formulation, low dose |
| Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®) | Experimental | Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28. Receives: Biological: MV-CHIK SPS® formulation, low dose |
| Group D: Two MV-CHIK liquid frozen high dose | Experimental | Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28. Receives: Biological: MV-CHIK liquid frozen formulation, high dose |
| Group E: One MV-CHIK liquid frozen high dose/placebo | Experimental | Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28. Receives: Biological: MV-CHIK liquid frozen formulation, high dose; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
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.
Measured: 28 days after last vaccination (Up to Day 56)
Secondary outcomes (15)
Percentage of Participants With Solicited and Unsolicited Adverse Events
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.
Measured: Up to Day 56
Percentage of Participants With at Least 1 Serious Adverse Event
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.
Measured: Up to Day 56
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
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).
Measured: Up to Day 365
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
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.
Measured: Up to Day 56
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
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.
Measured: Up to Day 365
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA.
Measured: Up to Day 56
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
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.
Measured: Up to Day 56
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
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.
Measured: Up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start22 Aug 2018
- Primary completion25 Jan 2019
- Study completion16 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chikungunya Virus InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Themis Bioscience GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635086
- Sponsor's protocol ID
- V184-005
- Other IDs
- 2018-000211-25, MV-CHIK-205, 2018
- Status last verified
- Oct 2021
- First submitted
- 24 Jul 2018
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2.
PubMed 25739878
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03635086
- Acronym / sponsor ID
- V184-005
- Conditions
- Chikungunya Virus Infection
- Keywords
- Chikungunya fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 16 Nov 2019 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 20 Oct 2021
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 investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Two MV-CHIK lyophilized low dose | Experimental | Biological: MV-CHIK lyophilised formulation, low doseParticipants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28. |
| Group B: Two MV-CHIK liquid frozen low dose | Experimental | Biological: MV-CHIK liquid frozen formulation, low doseParticipants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28. |
| Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®) | Experimental | Biological: MV-CHIK SPS® formulation, low doseParticipants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28. |
| Group D: Two MV-CHIK liquid frozen high dose | Experimental | Biological: MV-CHIK liquid frozen formulation, high doseParticipants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28. |
| Group E: One MV-CHIK liquid frozen high dose/placebo | Experimental | Biological: MV-CHIK liquid frozen formulation, high dose, Other: PlaceboParticipants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| MV-CHIK lyophilised formulation, low doseMV-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. | Biological | Group A: Two MV-CHIK lyophilized low dose |
| MV-CHIK liquid frozen formulation, low doseMV-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. | Biological | Group B: Two MV-CHIK liquid frozen low dose |
| MV-CHIK SPS® formulation, low doseMV-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. | Biological | Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®) |
| MV-CHIK liquid frozen formulation, high doseMV-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. | Biological | Group D: Two MV-CHIK liquid frozen high dose, Group E: One MV-CHIK liquid frozen high dose/placebo |
| PlaceboSterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection. | Other | Group E: One MV-CHIK liquid frozen high dose/placebo |
Primary outcome
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.
15 secondary outcomes
Percentage of Participants With Solicited and Unsolicited Adverse Events
Time frame: Up to Day 56
Percentage of Participants With at Least 1 Serious Adverse Event
Time frame: Up to Day 56
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Time frame: Up to Day 365
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
Time frame: Up to Day 56
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Time frame: Up to Day 365
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Time frame: Up to Day 56
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
Time frame: Up to Day 56
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
Time frame: Up to Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25739878Ramsauer K, Schwameis M, Firbas C, Mullner M, Putnak RJ, Thomas SJ, Despres P, Tauber E, Jilma B, Tangy F. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MV-CHIK lyophilised formulation, low dose, MV-CHIK liquid frozen formulation, low dose and MV-CHIK SPS® formulation, low dose in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 22 Oct 2021. 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 United Kingdom. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03635086, which also lists 1 linked publication.
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 22 Oct 2021.