A Phase 1 interventional study of MV-ZIKA and Placebo in Zika Virus, sponsored by Themis Bioscience GmbH. Completed at 2 sites in Austria. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Themis Bioscience GmbH (part of Merck & Co., Inc) · Phase 1, Interventional, and Prevention
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.
After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.
Subjects will return on day 56 for the final visit.
65 studies on the registry are indexed under Zika Virus Infection; 5 are open to participants now.
This study's enrollment of 48 is below the median of 85 across 36 interventional studies indexed under Zika Virus Infection.
Browse Zika Virus Infection studies →Themis Bioscience GmbH is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted before Themis Bioscience GmbH became part of Merck & Co., Inc.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
MV-ZIKA, high dose, one vaccination, day 0
Biological: MV-ZIKA · Other: Placebo
MV-ZIKA, low dose, two vaccinations, day 0 and day 28
Biological: MV-ZIKA
MV-ZIKA, high dose, two vaccinations, day 0 and day 28
Biological: MV-ZIKA
Physiological saline, two treatments
Other: Placebo
MV-Zika vaccine
physiological saline
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Functional anti-Zika antibodies as measured by PRNT.
Time frame: 56 days
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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