NCT02861586

Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Themis Bioscience GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chikungunya Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	MV-CHIK low dose	recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose
BIOLOGICAL	MV-CHIK high dose	recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose
BIOLOGICAL	Priorix®	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
BIOLOGICAL	physiological saline solution	sterile physiological saline solution 0.9% used as placebo

Timeline

• Start date: 2016-08-17
• Primary completion: 2017-09-01
• Completion: 2018-04-16
• First posted: 2016-08-10
• Last updated: 2021-10-29
• Results posted: 2021-06-08

Locations

4 sites across 2 countries: Austria, Germany