Chikungunya Virus InfectionPhase 2MV-CHIK-202NCT02861586
Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine
A Phase 2 study testing MV-CHIK low dose, MV-CHIK high dose and Priorix® in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels. 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 low dose, MV-CHIK high dose and Priorix®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Aug 2016to 16 Apr 2018
- 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
- Signed informed consent obtained before any trial-related activities.
- Ability 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
- Available for the duration of the trial
- Healthy men or women aged >18 and <55 years
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception as specified in protocol
- Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
- Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)
Who cannot join
- Participation in another clinical study within the past month in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period
- History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection,
- Drug addiction including alcohol dependence
- Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer or 0.25 L of wine)
- Persons who are accommodated in an institution on court or official order.
- Persons in direct relationship with the sponsor, an Investigator or other study site staff. Direct relationship includes relatives or close dependents (children, spouse/partner, siblings or parents), as well as employees (site or sponsor).
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- Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine during the study period.
- Measles vaccination or booster within the last 5 years or during the clinical study
- Prior receipt of any Chikungunya vaccine
- Blood donations during 1 month prior to Screening Visit and throughout the study
- Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be basis for temporary deferral)
- Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
- 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.
- History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease).
- History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
- 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.
- History of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the volunteers
- Clinically relevant abnormal laboratory values indicative of physical illness
- Hematology: hemoglobin, hematocrit, erythrocyte count, differential white blood count, platelets
- Chemistry: creatinine (≥1.7 mg/dL), potassium, sodium, calcium, aspartate transaminase/alanine aminotransferase (AST/ALT) ≥ 2.6 upper limit of normal (ULN), alkaline phosphatase, bilirubin
- Coagulation parameter: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen according to the evaluation of the principle investigator
- Urinalysis according to the evaluation of the principle investigator
- Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers may affect the validity of the study except hormonal contraception in female subjects; prior to taking any medication during 72 h prior to the first vaccination, the study center should be consulted.
- Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during the trial.
- Receipt of blood products or immunoglobulins within 120 days prior to Screening Visit or anticipated receipt of any blood products or immunoglobulin during the trial.
- Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential (for details please refer to section 8.3.6)
- Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
- Inability or unwillingness to provide informed consent and to abide by the requirements of the study
- Refusal to allow storage of specimens for future research.
- Regular blood plasma donations
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria2 sites
Hansa Sanatorium GmbH
Graz, 8010
Medical University Vienna, Department of Clinical Pharmacology
Vienna, 1090
Germany2 sites
Berliner Center for Travel- and Tropical Medicine
Berlin, 10117
Medicinal University Rostock, Department for Tropical Medicin and infectious diseases
Rostock, 18057
About this study
Official title: Double Blinded, Randomized, Priorix®- and Placebo-controlled, Trial to Evaluate the Optimal Dose of MV-CHIK Vaccine (Against Chikungunya Virus) in Regard to Immunogenicity, Safety and Tolerability in Healthy Volunteers
The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.
Read the detailed description
This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus).
Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®.
All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine).
All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination).
All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK on day 168 and on day 196.
All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (~8 months), respectively.
- Conditions
- Chikungunya Virus Infection
- Being tested
- MV-CHIK low dose, MV-CHIK high dose, Priorix®, physiological saline solution
- Keywords
- Chikungunya, infectious disease
- Medical subject headings
- Chikungunya Fever, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV-CHIK low doseBiological
Also called vaccine against Chikungunya
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
MV-CHIK high doseBiological
Also called vaccine against Chikungunya
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
Priorix®Biological
Also called vaccine against Measles, Mumps and Rubella
lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection
physiological saline solutionBiological
Also called 0.9% sodium chloride (NaCl)
sterile physiological saline solution 0.9% used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A; MV-CHIK low | Experimental | 60 subjects will receive i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK low dose; Biological: physiological saline solution |
| Treatment Group A/C; Priorix® | Active comparator | 20 subjects will receive i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: Priorix®; Biological: physiological saline solution |
| Treatment Group B; MV-CHIK low | Experimental | 60 subjects will receive i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK low dose; Biological: physiological saline solution |
| Treatment Group B/D; Priorix® | Active comparator | 20 subjects will receive i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: Priorix®; Biological: physiological saline solution |
| Treatment Group C; MV-CHIK high | Experimental | 60 subjects will receive i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK high dose; Biological: physiological saline solution |
| Treatment Group D; MV-CHIK high | Experimental | 60 subjects will receive i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK high dose; Biological: physiological saline solution |
| Measles Booster Group 1 | Experimental | 20 subjects will receive i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK low dose; Biological: Priorix®; Biological: physiological saline solution |
| Measles Booster Group 2 | Experimental | 20 subjects will receive i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196.
Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. Receives: Biological: MV-CHIK low dose; Biological: Priorix®; Biological: physiological saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.
Measured: Study day 56 (28 days after one or two vaccinations depending on treatment group).
Secondary outcomes (9)
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50).
Measured: Baseline until study day 224
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA).
Measured: Baseline until study day 56
Number of Participants With Solicited Local and Systemic Adverse Events
Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Measured: Solicited adverse events were recorded for 7 days after each vaccination
Number of Participants Who Experienced Treatment Emergent Adverse Events
Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Measured: First vaccination until study day 224
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR).
Measured: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196
Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR).
Measured: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Chikungunya Virus Specific T Cell Responses
Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis.
Measured: Baseline until study day 224
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA).
Measured: Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer
To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups.
Measured: Study day 56 (28 days after one or two vaccinations depending on treatment group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start17 Aug 2016
- Primary completion1 Sep 2017
- Study completion16 Apr 2018
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 (3)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 263 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
- NCT02861586
- Sponsor's protocol ID
- MV-CHIK-202
- Other IDs
- 2015-004037-26, V184-002, 2015
- Acronym
- MV-CHIK-202
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2016
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 25739878Tschismarov R, Zellweger RM, Koh MJ, Leong YS, Low JG, Ooi EE, Mandl CW, Ramsauer K, de Alwis R. Antibody effector analysis of prime versus prime-boost immunizations with a recombinant measles-vectored chikungunya virus vaccine. JCI Insight. 2021 Nov 8;6(21):e151095. doi: 10.1172/jci.insight.151095.
PubMed 34582377Reisinger EC, Tschismarov R, Beubler E, Wiedermann U, Firbas C, Loebermann M, Pfeiffer A, Muellner M, Tauber E, Ramsauer K. Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet. 2019 Dec 22;392(10165):2718-2727. doi: 10.1016/S0140-6736(18)32488-7. Epub 2018 Nov 5.
PubMed 30409443
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Priorix®- and Placebo-controlled, Trial to Evaluate the Optimal Dose of MV-CHIK Vaccine (Against Chikungunya Virus) in Regard to Immunogenicity, Safety and Tolerability in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02861586
- Acronym / sponsor ID
- MV-CHIK-202 / MV-CHIK-202
- Conditions
- Chikungunya Virus Infection
- Keywords
- Chikungunya, infectious disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 8 Jun 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 evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.
Detailed description
This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus).
Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®.
All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine).
All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination).
All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK on day 168 and on day 196.
All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (~8 months), respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A; MV-CHIK low | Experimental | Biological: MV-CHIK low dose, Biological: physiological saline solution60 subjects will receive i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Treatment Group A/C; Priorix® | Active comparator | Biological: Priorix®, Biological: physiological saline solution20 subjects will receive i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Treatment Group B; MV-CHIK low | Experimental | Biological: MV-CHIK low dose, Biological: physiological saline solution60 subjects will receive i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Treatment Group B/D; Priorix® | Active comparator | Biological: Priorix®, Biological: physiological saline solution20 subjects will receive i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Treatment Group C; MV-CHIK high | Experimental | Biological: MV-CHIK high dose, Biological: physiological saline solution60 subjects will receive i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Treatment Group D; MV-CHIK high | Experimental | Biological: MV-CHIK high dose, Biological: physiological saline solution60 subjects will receive i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Measles Booster Group 1 | Experimental | Biological: MV-CHIK low dose, Biological: Priorix®, Biological: physiological saline solution20 subjects will receive i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
| Measles Booster Group 2 | Experimental | Biological: MV-CHIK low dose, Biological: Priorix®, Biological: physiological saline solution20 subjects will receive i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. Physical examinations, vital signs, pregnancy tests for females, inquiry of adverse events and collection of immunogenicity blood samples will be performed during all visits. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent obtained before any trial-related activities.
- Ability 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
- Available for the duration of the trial
- Healthy men or women aged >18 and <55 years
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception as specified in protocol
Key exclusion criteria (32 listed)
- Participation in another clinical study within the past month in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period
- History of immunodeficiency, known human immunodeficiency virus (HIV) infection, current hepatitis B/C infection,
- Drug addiction including alcohol dependence
- Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer or 0.25 L of wine)
- Persons who are accommodated in an institution on court or official order.
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 low doseAlso: vaccine against Chikungunyarecombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose | Biological | Measles Booster Group 1, Measles Booster Group 2, Treatment Group A; MV-CHIK low, Treatment Group B; MV-CHIK low |
| MV-CHIK high doseAlso: vaccine against Chikungunyarecombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose | Biological | Treatment Group C; MV-CHIK high, Treatment Group D; MV-CHIK high |
| Priorix®Also: vaccine against Measles, Mumps and Rubellalyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection | Biological | Measles Booster Group 1, Measles Booster Group 2, Treatment Group A/C; Priorix®, Treatment Group B/D; Priorix® |
| physiological saline solutionAlso: 0.9% sodium chloride (NaCl)sterile physiological saline solution 0.9% used as placebo | Biological | Measles Booster Group 1, Measles Booster Group 2, Treatment Group A/C; Priorix®, Treatment Group A; MV-CHIK low, Treatment Group B/D; Priorix®, Treatment Group B; MV-CHIK low, Treatment Group C; MV-CHIK high, Treatment Group D; MV-CHIK high |
Primary outcome
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Time frame: Study day 56 (28 days after one or two vaccinations depending on treatment group).
Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.
9 secondary outcomes
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50)
Time frame: Baseline until study day 224
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
Time frame: Baseline until study day 56
Number of Participants With Solicited Local and Systemic Adverse Events
Time frame: Solicited adverse events were recorded for 7 days after each vaccination
Number of Participants Who Experienced Treatment Emergent Adverse Events
Time frame: First vaccination until study day 224
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
Time frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196
Time frame: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
Chikungunya Virus Specific T Cell Responses
Time frame: Baseline until study day 224
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Time frame: Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer
Time frame: Study day 56 (28 days after one or two vaccinations depending on treatment group)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Derived from this study: PubMed 34582377Tschismarov R, Zellweger RM, Koh MJ, Leong YS, Low JG, Ooi EE, Mandl CW, Ramsauer K, de Alwis R. Antibody effector analysis of prime versus prime-boost immunizations with a recombinant measles-vectored chikungunya virus vaccine. JCI Insight. 2021 Nov 8;6(21):e151095. doi: 10.1172/jci.insight.151095.
- Derived from this study: PubMed 30409443Reisinger EC, Tschismarov R, Beubler E, Wiedermann U, Firbas C, Loebermann M, Pfeiffer A, Muellner M, Tauber E, Ramsauer K. Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial. Lancet. 2019 Dec 22;392(10165):2718-2727. doi: 10.1016/S0140-6736(18)32488-7. Epub 2018 Nov 5.
- Individual participant dataSharing planned: No
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MV-CHIK low dose, MV-CHIK high dose and Priorix® in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 4 sites in 2 countries.
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 32 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 29 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 4 sites in Austria, Germany. 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 8 Jun 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?
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50) (time frame: Study day 56 (28 days after one or two vaccinations depending on treatment group).). 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 NCT02861586, which also lists 3 linked publications.
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 29 Oct 2021.