Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): MV-CHIK low dose; MV-CHIK high dose; Priorix®; physiological saline solution
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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
Other intervention name(s): vaccine against Chikungunya; vaccine against Chikungunya; vaccine against Measles, Mumps and Rubella; 0.9% sodium chloride (NaCl)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Chikungunya, infectious disease