NCT03635086 - Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 22, 2018

Primary Completion Date

January 25, 2019

Study Completion Date

November 16, 2019

Conditions

Chikungunya Virus Infection

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

OTHER

Placebo

Sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.

Trial Locations (1)

BT9 6 AD

Celerion Belfast, Belfast

All Listed Sponsors

lead

Themis Bioscience GmbH

INDUSTRY