Status and phase
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About
In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject is 18 to 49 years of age on the day of screening (Visit 0);
Subject has a Body Mass Index (BMI) of ≥18.5 and <30 kg/m2 on the day of screening (Visit 0);
Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
Subject is generally healthy as determined by the Investigator's clinical judgment based on medical history, physical examination and screening laboratory tests;
If subject is of childbearing potential:
i. Subject has a negative serum pregnancy test at screening (Visit 0);
ii. Subject agrees to employ adequate birth control measures for the duration of the study. This includes one of the following measures:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
67 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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