Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
NCT ID: NCT03635086
Last Updated: 2021-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2018-08-22
2019-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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 lyophilised formulation, low dose
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.
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 liquid frozen formulation, low dose
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.
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 SPS® formulation, low dose
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.
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 liquid frozen formulation, high dose
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.
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 liquid frozen formulation, high dose
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.
Placebo
Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
Interventions
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MV-CHIK lyophilised formulation, low dose
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 dose
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 dose
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 dose
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.
Placebo
Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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Themis Bioscience GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Celerion Belfast
Belfast, Northern Ireland, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-000211-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MV-CHIK-205
Identifier Type: OTHER
Identifier Source: secondary_id
V184-005
Identifier Type: -
Identifier Source: org_study_id