Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Intervention: 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
Intervention description: 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, 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, 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, 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chikungunya fever

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.
    

Eligibility criteria:

        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