NCT00500747

Brief Summary

The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to 60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of 4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo (shot with no medication). Participants will be involved in study related procedures for up to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine or placebo injections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

July 12, 2007

Last Update Submit

June 9, 2011

Conditions

Hepatitis C

Keywords

hepatitis C, HCV, vaccine, recombinant vaccine, adjuvant

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety, tolerability, and immunogenicity of HCV E1E2/MF59 vaccine when administered at 3 dose levels on a multi-dose schedule.

    Duration of study.

Secondary Outcomes (1)

  • Compare the immune response to HCV E1E2 vaccine given at 4 mcg, 20 mcg, or 100 mcg in MF59 adjuvant.

    Weeks 0, 2, 4, 6, 8, 24, 26, 50, 52 and 64.

Study Arms (3)

Group C: 100 mcg HCV E1E2/MF59 vaccine

EXPERIMENTAL

Sixteen subjects receive four doses of 100 mcg HCV E1E2/MF59 vaccine (0.5 mL total volume) and 4 subjects receive placebo at 0, 4, 24, and 48 weeks.

Biological: HCV E1E2/MF59Drug: Placebo

Group B: 20 mcg HCV E1E2/MF59 vaccine

EXPERIMENTAL

Sixteen subjects receive four doses of 20 mcg HCV E1E2/MF59 vaccine (0.5 mL total volume) and 4 subjects receive placebo at 0, 4, 24, and 48 weeks.

Biological: HCV E1E2/MF59Drug: Placebo

Group A: 4 mcg HCV E1E2/MF59 vaccine

EXPERIMENTAL

Sixteen subjects receive four doses of 4 mcg HCV E1E2/MF59 vaccine (0.5 mL total volume) and 4 subjects receive placebo at 0, 4, 24, and 48 weeks.

Biological: HCV E1E2/MF59Drug: Placebo

Interventions

HCV E1E2/MF59BIOLOGICAL

The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.

Group A: 4 mcg HCV E1E2/MF59 vaccineGroup B: 20 mcg HCV E1E2/MF59 vaccineGroup C: 100 mcg HCV E1E2/MF59 vaccine
PlaceboDRUG

Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.

Group A: 4 mcg HCV E1E2/MF59 vaccineGroup B: 20 mcg HCV E1E2/MF59 vaccineGroup C: 100 mcg HCV E1E2/MF59 vaccine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, hepatitis C virus (HCV) negative.
  • year old healthy adults. Insufficient data are available in adults to judge risk in children.
  • In good general health as determined by medical history, physical examination and the following screening labs:
  • Complete Blood Count (CBC): Total WBC (White Blood Cell): 3.5-14 thousand/microliter (MCL); Hemoglobin (Hgb): Men: 12.2-18 g/dl and Women: 10.5-17 g/dl.
  • Creatinine: Men: less than or equal to 1.4 mg/dl; Women: less than or equal to 1.2 mg/dl.
  • Glucose: 50 mg/dl to less than or equal to 109 mg/dl.
  • Alanine Aminotransferase (ALT): Men 2-60 units/litre (U/I): Women: 3-40 U/I.
  • Aspartate Aminotransferase (AST): Men: 2-50 U/I, Women 2-35 U/I.
  • Total bilirubin: Men: less than or equal to 1.5 mg/dl: Women: less than or equal to 1.3 mg/dl.
  • Urinalysis: negative or trace protein, negative glucose, less than or equal to 3 Red Blood Cells (RBC)/High Power Field (HPF) and less than or equal to 5WBC/HPF (in nonmenstruating females).
  • Negative serum cryoglobulin
  • Hepatitis B: negative Hepatitis B Surface Antigen (HBsAg) (using standard Food and Drug Administration FDA approved tests, e.g. Abbott or Organon).
  • Hepatitis C: Anti-Hepatitis C Virus (HCV) negative and HCV Ribonucleic Acid (RNA) negative (using standard FDA approved tests, e.g. Abbott or Organon).
  • HIV ELISA negative (using standard FDA approved tests, e.g. Abbott or Organon) (Written informed consent for HIV antibody testing will be obtained before obtaining the HIV sample.) Note: HIV vaccine volunteers who test positive by HIV ELISA and HIV western blot testing due to receipt of HIV vaccine may participate if they test negative by HIV DNA Polymerase Chain Reaction (PCR).
  • Negative urine pregnancy test (females of child bearing potential) obtained at screening and at the day of each immunization.
  • +1 more criteria

You may not qualify if:

  • Diabetes.
  • Cancer other than squamous cell skin cancer which has been excised.
  • History of myocardial infarction or arrhythmia requiring hospitalization.
  • Syncope requiring hospitalization.
  • Unconsciousness other than a simple concussion.
  • Seizures other than febrile seizures as a child \<5 years of age.
  • Current liver disease (not including Gilbert's disease).
  • Autoimmune disease (does not include thyroid disease or vitiligo).
  • Splenectomy.
  • Uncontrolled hypertension \[blood pressure (BP) \>150/90; anti-hypertensive medications are acceptable).
  • Subjects with identifiable high-risk behavior for HCV infection as characterized by the following: injection drug use (IVDU) or cocaine snorting within the last year.
  • Subject had a tattoo or body piercing within the past 6 months and/or is planning to acquire any tattoos or body piercing during the period of the study.
  • Subjects with tattoos at the bilateral sites of needle insertion.
  • Pregnant or lactating women. Women of child bearing potential must be using effective contraception for at least 30 days prior to initial immunization, unless for religious, social, or medical reasons they do not intend to have children and are practicing sexual abstinence. Subjects using birth control must agree to do so for the entire 64 week study period. Acceptable method of birth control is defined as hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, condoms, a vasectomized partner or abstinence.
  • Personnel engaged in the blinding of this study.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Nguyen YTK, Chen F, Giang E, Saha S, Ueno LA, Chen C, Watson CT, Tzarum N, Wilson IA, Law M, Stanfield R. Structural and genetic signatures of two classes of HCV E2 neutralizing face antibodies from non-human primates immunized with a recombinant E1E2. bioRxiv [Preprint]. 2025 Oct 7:2025.10.07.680784. doi: 10.1101/2025.10.07.680784.

    PMID: 41278834DERIVED

  • Chen F, Nagy K, Chavez D, Willis S, McBride R, Giang E, Honda A, Bukh J, Ordoukhanian P, Zhu J, Frey S, Lanford R, Law M. Antibody Responses to Immunization With HCV Envelope Glycoproteins as a Baseline for B-Cell-Based Vaccine Development. Gastroenterology. 2020 Mar;158(4):1058-1071.e6. doi: 10.1053/j.gastro.2019.11.282. Epub 2019 Dec 4.

    PMID: 31809725DERIVED

  • Kachko A, Frey SE, Sirota L, Ray R, Wells F, Zubkova I, Zhang P, Major ME. Antibodies to an interfering epitope in hepatitis C virus E2 can mask vaccine-induced neutralizing activity. Hepatology. 2015 Dec;62(6):1670-82. doi: 10.1002/hep.28108. Epub 2015 Oct 16.

    PMID: 26251214DERIVED

  • Frey SE, Houghton M, Coates S, Abrignani S, Chien D, Rosa D, Pileri P, Ray R, Di Bisceglie AM, Rinella P, Hill H, Wolff MC, Schultze V, Han JH, Scharschmidt B, Belshe RB. Safety and immunogenicity of HCV E1E2 vaccine adjuvanted with MF59 administered to healthy adults. Vaccine. 2010 Aug 31;28(38):6367-73. doi: 10.1016/j.vaccine.2010.06.084. Epub 2010 Jul 7.

    PMID: 20619382DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

August 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

June 10, 2011

Record last verified: 2010-04

Locations

US(1)