Safety Study of Hepatitis E Vaccine (HEV239)

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

April 12, 2019

Primary Completion Date

August 28, 2020

Study Completion Date

August 28, 2020

Conditions
Hepatitis EImmunisation
Interventions
BIOLOGICAL

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.

OTHER

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 \[4.5 - 7.0\]).

Trial Locations (1)

30322-1014

Emory Children's Center - Pediatric Infectious Diseases, Atlanta

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03827395 - Safety Study of Hepatitis E Vaccine (HEV239) | Biotech Hunter | Biotech Hunter