25
Participants
Start Date
April 12, 2019
Primary Completion Date
August 28, 2020
Study Completion Date
August 28, 2020
HEV 239
Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide.
Placebo
0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 \[4.5 - 7.0\]).
Emory Children's Center - Pediatric Infectious Diseases, Atlanta
National Institute of Allergy and Infectious Diseases (NIAID)
NIH