NCT02189603

Brief Summary

The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2015

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

July 9, 2014

Last Update Submit

August 15, 2018

Conditions

Hepatitis E

Keywords

hepatitis EImmunogenicityvaccinesafety

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.

    From month 0-7

Secondary Outcomes (2)

  • anti-HEV IgG seropositive rate

    at month 7

  • GMT of anti-HEV IgG

    7 month after first vaccination

Study Arms (3)

Senior group(over 65 years old)-HE

EXPERIMENTAL

Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.

Biological: Recombinant (E. Coli) Hepatitis E Vaccine

Younger groups(16-65 years old)

ACTIVE COMPARATOR

Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.

Biological: Recombinant (E. Coli) Hepatitis E Vaccine

Senior group(over 65 years old)-Cont

NO INTERVENTION

Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention.

Interventions

Recombinant (E. Coli) Hepatitis E VaccineBIOLOGICAL
Also known as: Hecolin®
Senior group(over 65 years old)-HEYounger groups(16-65 years old)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
  • Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
  • Subjects will reside in the study region in the next 7 months.
  • Free of history of hepatitis E.
  • Can comply with the request of study.
  • Axillary temperature is below 37 degree centigrade.

You may not qualify if:

  • For dose 1:
  • receiving other vaccine or immunoglobulin within two weeks;
  • Having serious allergic history to vaccine and medicine
  • Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
  • Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
  • Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
  • Congenital malformation, eccyliosis or severe chronic disease;
  • Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
  • joining other clinical study undergoing;
  • women pregnant or in lactation.
  • For dose 2 or 3:
  • Severe allergy for dose 1 or 2;
  • Severe adverse reaction associated with last vaccination;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for disease control and prevention in Xiamen haicang district

Xiamen, Fujian, 361000, China

Location

Related Publications (1)

  • Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.

    PMID: 20728932BACKGROUND

MeSH Terms

Conditions

Hepatitis E

Interventions

hecolin

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor，Xiamen University

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 14, 2014

Study Start

June 1, 2014

Primary Completion

December 7, 2015

Study Completion

December 7, 2015

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

CN(1)