A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection
Johnson County Clin-Trials(JCCT)
Lenexa, Kansas, United States
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Time frame: 42 days after vaccination
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Time frame: 29 days after vaccination
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