A Study of the Immune Response to Heplisav in Healthy Old... | NCT01999699

Studies
A Study of the Immune Response to Heplisav in Healthy Older Adults

NCT01999699

Sponsor

Dynavax Technologies Corporation

Status

Completed

Last Update Posted

Mar 20, 2019Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Hepatitis B

Interventions

HEPLISAV

Countries

United States

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

Mar 2019

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

Nov 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Nov 26, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 3, 2013Estimated

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

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Name	Class
Baylor Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.

Detailed Description

The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
HEPLISAV	Experimental		Biological: HEPLISAV

Name	Type	Description	Arm Group Labels	Other Names
HEPLISAV	Biological		HEPLISAV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.		Day 1, 3, and 7 and on Day 28
Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).		Day 1, 3, and 7 and on Day 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50 to 70 years of age, inclusive
In good health in the opinion of the principal investigator, based upon medical history and physical examination
Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10

Exclusion Criteria:

Pregnant, breastfeeding, or planning a pregnancy
Known history of an autoimmune disease
Previously received any hepatitis B vaccine (approved or investigational)
Body-mass index (BMI) >30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Janssen, MD	Dynavax Technologies Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johnson County Clinical Trials		Lenexa	Kansas	66219	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

a/o August 2016, decision still pending.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017325	Hepatitis B Vaccines

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided