Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine
MV-CHIK-202
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
3 other identifiers
interventional
263
2 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedStudy Start
First participant enrolled
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2018
CompletedResults Posted
Study results publicly available
June 8, 2021
CompletedOctober 29, 2021
October 1, 2021
1 year
July 28, 2016
March 17, 2021
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
Baseline until study day 224
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay
Baseline until study day 56
Number of Participants With Solicited Local and Systemic Adverse Events
Solicited adverse events were recorded for 7 days after each vaccination
Number of Participants Who Experienced Treatment Emergent Adverse Events
First vaccination until study day 224
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196
Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196
- +4 more secondary outcomes
Study Arms (8)
Treatment Group A; MV-CHIK low
EXPERIMENTAL60 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 COMPARATOR20 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
EXPERIMENTAL60 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 COMPARATOR20 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
EXPERIMENTAL60 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
EXPERIMENTAL60 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
EXPERIMENTAL20 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
EXPERIMENTAL20 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.
Interventions
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
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
sterile physiological saline solution 0.9% used as placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hansa Sanatorium GmbH
Graz, 8010, Austria
Medical University Vienna, Department of Clinical Pharmacology
Vienna, 1090, Austria
Berliner Center for Travel- and Tropical Medicine
Berlin, 10117, Germany
Medicinal University Rostock, Department for Tropical Medicin and infectious diseases
Rostock, 18057, Germany
Related Publications (3)
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.
PMID: 25739878BACKGROUNDTschismarov 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.
PMID: 34582377DERIVEDReisinger 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.
PMID: 30409443DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 10, 2016
Study Start
August 17, 2016
Primary Completion
September 1, 2017
Study Completion
April 16, 2018
Last Updated
October 29, 2021
Results First Posted
June 8, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share