Trials / Completed
CompletedNCT03635086
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Themis Bioscience GmbH · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-22
- Primary completion
- 2019-01-25
- Completion
- 2019-11-16
- First posted
- 2018-08-17
- Last updated
- 2021-10-22
- Results posted
- 2021-10-20
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03635086. Inclusion in this directory is not an endorsement.