Chikungunya Vaccine Study in Previously Exposed Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03807843|
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chikungunya Virus Infection||Biological: MV-CHIK Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, placebo controled, randomized, double-blinded, interventional, safety study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Study medication is available as liquid frozen vaccine product or saline for injection (placebo).
The actual study injections will be prepared by an unblinded team member (e.g. pharmacy personnel) and will be forwarded to the investigator (injector) in a blinded fashion (injection ready syringes containing either verum or placebo). The injector, study subjects, or other site personnel are not informed about the study treatment until unblinding may occur.
|Official Title:||Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults|
|Actual Study Start Date :||July 16, 2019|
|Estimated Primary Completion Date :||March 4, 2021|
|Estimated Study Completion Date :||March 4, 2021|
Experimental: Treatment Arm
Subjects randomized to the treatment arm will receive two vaccinations with MV-CHIK, a recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. The vaccinations will be provided on days 0 and 28 after enrollment.
Liquid frozen, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose.
Placebo Comparator: Placebo Arm
Subjects randomized to the placebo arm will receive two injections of sterile physiological saline. The injections will be provided on days 0 and 28 after enrollment.
Sterile physiological saline for injection
- Frequency of Adverse Events [ Time Frame: 28 weeks ]Incidence of solicited and unsolicited adverse events from enrollment until end of study.
- Chikungunya Antibody Titer [ Time Frame: 28 weeks ]Geometric mean titer (GMT) of neutralizing antibodies to chikungunya evaluated on days 0, 28, 56, and at the end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807843
|Contact: Raimund M. Vielnascher, MSc||+43 676 84 34 96 ext email@example.com|
|Contact: Souyet Chang-Rodriguez, PhD||+43 676 84 34 96 ext firstname.lastname@example.org|
|San Juan Hospital, Research Unit||Recruiting|
|San Juan, Puerto Rico, 00935|
|Contact: Nicolas Rosario-Matos, MD, MSc +1 787 764 ext 3083 email@example.com|
|Contact: Lizbet Fabregas-Troche, MSc +1 787 764 ext 3083 firstname.lastname@example.org|