Dose of Hepatitis B Vaccines in Non/Low-response Populations | NCT01564134

Studies
Dose of Hepatitis B Vaccines in Non/Low-response Populations

NCT01564134

Sponsor

Wu Jiang

Status

Completed

Last Update Posted

Jul 10, 2013Estimated

Enrollment

537Actual

Phase

Not Applicable

Conditions

Vaccination; Complications, Reaction, Serum

Interventions

hepatitis B vaccine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 23, 2012

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2013

Last Update Posted Date

Jul 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wu Jiang, Department of Immunization & Prevention, Centers for Disease Control and Prevention, ChinaSponsor-Investigator

Lead Sponsor

Wu JiangOTHER_GOV

Collaborators

Name	Class
Beijing Municipal Science & Technology Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis B vaccines in low or non-response population.

Detailed Description

A randomized clinical study will be conducted to evaluate effects of different doses of hepatitis B vaccines in low or non-response population in China. 650 low or non-response subjects after hepatitis B vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. Group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug HBs-Ag respectively. Group 4 will receive 1 dose of vaccine with 60ug HBs-Ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection.

The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

537Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HepB 5ug	Experimental	receive the vaccine with 5ug HBsAg	Biological: hepatitis B vaccine
HepB 10ug	Experimental	receive the vaccine with 10ug HBsAg	Biological: hepatitis B vaccine
HepB 20ug	Experimental	receive the vaccine with 20ug HBsAg	Biological: hepatitis B vaccine
HepB 60ug	Experimental	receive the vaccine with 60ug HBsAg	Biological: hepatitis B vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hepatitis B vaccine	Biological	hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg	HepB 10ug HepB 20ug HepB 5ug HepB 60ug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seroconversion rates of different doses of vaccines the levels of HBs-Ab after vaccination	describe the levels of HBs-Ab after each vaccination and compare the percentages of adverse events in all groups	day 30 after each vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 1-65 years old
male or non-pregnant female volunteers
provide written informed consents before joining the trial
clinically healthy as determined by: medical history inquiring and physical examination
negative for HBsAg,HBsAb,HBcAb,HBeAg,HBeAb within the past 1 year

Exclusion Criteria:

No history of hepatitis B vaccine
receipt of immunoglobulin within the past 1 month
allergic to any ingredient of vaccine
history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain
severe acute and chronic diseases
autoimmune disease or immune deficiency
axillary temperature > 37.0 ℃ over the time of vaccination

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jiang wu, Bachelor	Beijing Centers for Disease Control and Prevention	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xicheng Centers For Disease Prevention & Control		Xicheng District	Beijing Municipality	100011	China

Intervention Browse Module

MeSH Terms

ID	Term
D017325	Hepatitis B Vaccines
C020361	gamma-hydroxy-gamma-ethyl-gamma-phenylbutyramide

Ancestor Terms

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products

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