Safety Study of Hepatitis E Vaccine (HEV239)
Condition: Hepatitis E; Immunisation
MeSH terms: Hepatitis A; Hepatitis E; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to
      vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R)
      (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the
      safety, reactogenicity, and immunogenicity of HEV-239. Subjects will receive 3 doses of study
      product on Days 1, 29, and 180. Subjects will remain in the study for up to 13 months
      (including screening). The study duration will be approximately 15 months. Subjects will be
      observed for 30 minutes after vaccination. The occurrence of solicited injection site and
      systemic reactogenicity events will be measured from the time of study vaccination through
      Day 8 after each vaccination. These will be ascertained through use of an electronic memory
      (e-memory) aid, a telephone call on day 4 after each dose of vaccine, a Day 8 clinic visit,
      and potentially at the Day 15 clinic visit after each dose of vaccine. Unsolicited adverse
      events will be collected from vaccination through Day 29 after each vaccination. Serious
      adverse events will be collected from the time of the first study vaccination through the
      last study visit (Day 360). The study includes multiple phlebotomy time points for
      immunogenicity and blood collection for future use at visit 1 and Days 8, 15, and 29 after
      each vaccination. The durability of the immune response and future use collection will be
      assessed at 5 months after the first boost (Day 180) and at 6 months after the second boost
      (Day 360). The primary objectives of the study are to; 1) assess the safety and
      reactogenicity of HEV-239 following delivery of each vaccine dose; and 2) assess the number
      of subjects with > / = 4 fold rise in Hepatitis E virus (HEV) immunoglobulin G (IgG) at any
      time after vaccination.
    

Detailed description: 
      This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to
      vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R)
      (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the
      safety, reactogenicity, and immunogenicity of HEV-239. Subjects will receive 3 doses of study
      product on Days 1, 29, and 180. Subjects will remain in the study for up to 13 months
      (including screening). The study duration will be approximately 15 months. Subjects will be
      observed for 30 minutes after vaccination. The occurrence of solicited injection site and
      systemic reactogenicity events will be measured from the time of study vaccination through
      Day 8 after each vaccination. These will be ascertained through use of an electronic memory
      (e-memory) aid, a telephone call on day 4 after each dose of vaccine, a Day 8 clinic visit,
      and potentially at the Day 15 clinic visit after each dose of vaccine. Unsolicited adverse
      events will be collected from vaccination through Day 29 after each vaccination. Serious
      adverse events will be collected from the time of the first study vaccination through the
      last study visit (Day 360). The study includes multiple phlebotomy time points for
      immunogenicity and blood collection for future use at visit 1 and Days 8, 15, and 29 after
      each vaccination. The durability of the immune response and future use collection will be
      assessed at 5 months after the first boost (Day 180) and at 6 months after the second boost
      (Day 360). The primary objectives of the study are to; 1) Assess the safety and
      reactogenicity of HEV-239 following delivery of each vaccine dose; and 2) Assess the number
      of subjects with > / = 4 fold rise in Hepatitis E virus (HEV) immunoglobulin G (IgG) at any
      time after vaccination. The secondary objectives are to; 1) Assess the number of subjects
      with HEV immunoglobulin M (IgM) seroconversion at any time after vaccination; 2) Assess the
      number of subjects with HEV IgG seroconversion at any time after vaccination; and 3) Assess
      the HEV IgG geometric mean concentrations (GMCs) at any time after vaccination.
    

Intervention name(s): HEV 239; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 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.; 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]).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adult; Healthy; Hecolin; Hepatitis E; HEV239; Immunogenicity; Placebo; Population; Reactogenicity; Route; Safety; Vaccine