NCT02584543

Brief Summary

This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6. Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2016

Completed
Last Updated

December 4, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

October 21, 2015

Last Update Submit

December 1, 2017

Conditions

Hepatitis EHepatitis B

Outcome Measures

Primary Outcomes (1)

  • Adverse reactions/events

    Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study

    7 months

Secondary Outcomes (1)

  • Immunogenicity

    7 months

Study Arms (3)

HEV vaccine and HBV vaccine Co-administration group

EXPERIMENTAL
Biological: HEV vaccineBiological: HBV vaccine

HEV vaccine control group

ACTIVE COMPARATOR
Biological: HEV vaccine

HBV vaccine control group

ACTIVE COMPARATOR
Biological: HBV vaccine

Interventions

HEV vaccineBIOLOGICAL
HEV vaccine and HBV vaccine Co-administration groupHEV vaccine control group
HBV vaccineBIOLOGICAL
HBV vaccine control groupHEV vaccine and HBV vaccine Co-administration group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy people aged over 18 years old on the day of enrollment
  • Negative in HBsAg,HBsAb and HBcAb.
  • Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations.
  • Able to understand this study information and willing to comply with all study requirements.
  • Willing to participate in this study and sign informed consent form.

You may not qualify if:

  • Pregnant or breastfeeding or planning on getting pregnant in the future 7 months
  • Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period
  • Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, exceptlocal treatment.
  • Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
  • Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
  • Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
  • Plan to participate in any other clinical trial during the study period
  • Administration of HEV vaccine before the study.
  • Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor,or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
  • History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang District CDC

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hepatitis EHepatitis B

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus Infections

Study Officials

  • Zheng Zhang

    Beijing Chaoyang District CDC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 22, 2015

Study Start

October 1, 2015

Primary Completion

August 25, 2016

Study Completion

August 25, 2016

Last Updated

December 4, 2017

Record last verified: 2017-12

Locations

CN(1)