HealthyPhase 3NCT01005407

Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

A Phase 3 study testing Engerix-B in people with Healthy, run by Dynavax Technologies Corporation at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Engerix-B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,452 participants
Where: 32 sitesin 2 countries
Study dates: Feb 2010to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

be 40 - 70 years of age, inclusive
be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection

Who cannot join

if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
has a known history of autoimmune disease
has previously received any hepatitis B vaccine (approved or investigational)

Trial locations and contacts

32 sites in 2 countries.

Country

City, postcode or hospital

32 sites in 2 countries

United States29 sites

Study site
Anderson, South Carolina
Study site
Atlanta, Georgia
Study site
Brooklyn Center, Minnesota
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Edina, Minnesota
Study site
Erie, Pennsylvania
Study site
Greer, South Carolina
Study site
Grove City, Pennsylvania
Study site
Huntsville, Alabama
Study site
Jefferson Hills, Pennsylvania
Study site
Kansas City, Missouri
Study site
Katy, Texas
Study site
Melbourne, Florida
Study site
Nashville, Tennessee
Study site
Norfolk, Virginia
Study site
Peoria, Illinois
Study site
Pinellas Park, Florida
Study site
Pittsburgh, Pennsylvania
Study site
Rochester, New York
Study site
Rockville, Maryland
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Santa Ana, California
Study site
South Bend, Indiana
Study site
St Louis, Missouri
Study site
Upper Saint Clair, Pennsylvania

Other trials in United States

Canada3 sites

Study site
Montreal, Quebec
Study site
Mount Pearl, Newfoundland and Labrador
Study site
Toronto, Ontario

Other trials in Canada

About this study

Official title: An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Read the detailed description

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Conditions: Healthy
Being tested: HEPLISAV and/or Placebo, Engerix-B
Keywords: HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control, Healthy, Healthy volunteers
Medical subject headings: Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HEPLISAV and/or PlaceboBiological
Also called Hepatitis B vaccine (recombinant), adjuvanted
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Engerix-BBiological
Also called Hepatitis B vaccine (recombinant)
Intramuscular (IM) injections on Week 0, Week 4 and Week 24

Study groups in NCT01005407
Study group	Role	What they receive
HEPLISAV and/or Placebo	Experimental	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Receives: Biological: HEPLISAV and/or Placebo
Engerix-B(1)	Active comparator	1.0 mL Engerix-B Receives: Biological: Engerix-B

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Who Have a Seroprotective Immune Response
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Measured: at Week 12 and at Week 32

Secondary outcomes (1)

Percentage of Participants With Local and Systemic Reaction to Injections
Measured: within 7 days for post-injection reactions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010May 2011

First posted2 Nov 2009 (estimated)
Study startFeb 2010
Primary completionJan 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01005407
Sponsor's protocol ID: DV2-HBV-16
Status last verified: Mar 2019
First submitted: 29 Oct 2009
Last updated: 20 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.
PubMed 23727002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
ClinicalTrials.gov ID: NCT01005407
Acronym / sponsor ID: DV2-HBV-16
Conditions: Healthy
Keywords: HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control, Healthy, Healthy volunteers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,452 participants (actual)
Lead sponsor: Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jan 2011 (actual)
Study completion: May 2011 (actual)
First posted: 2 Nov 2009 (estimated)
Results: Posted 11 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Detailed description

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HEPLISAV and/or Placebo	Experimental	Biological: HEPLISAV and/or Placebo0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Engerix-B(1)	Active comparator	Biological: Engerix-B1.0 mL Engerix-B

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

be 40 - 70 years of age, inclusive
be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection

Key exclusion criteria (4 listed)

if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
has a known history of autoimmune disease
has previously received any hepatitis B vaccine (approved or investigational)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HEPLISAV and/or PlaceboAlso: Hepatitis B vaccine (recombinant), adjuvantedIntramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24	Biological	HEPLISAV and/or Placebo
Engerix-BAlso: Hepatitis B vaccine (recombinant)Intramuscular (IM) injections on Week 0, Week 4 and Week 24	Biological	Engerix-B(1)

Primary outcome

Percentage of Subjects Who Have a Seroprotective Immune Response
Time frame: at Week 12 and at Week 32
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®

1 secondary outcome

Percentage of Participants With Local and Systemic Reaction to Injections
Time frame: within 7 days for post-injection reactions

Results and safety

Results posted to the registry on 11 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HEPLISAV and/or Placebo	1,969	1,818
Engerix-B	483	451

Primary outcome: Percentage of Subjects Who Have a Seroprotective Immune Response

Time frame: at Week 12 and at Week 32. Number. Unit: Percentage of participants

Measure	HEPLISAV and Placebo n = 1121	Engerix-B n = 353
Value	90.1	70.5

Population analysed: Non-Inferiority per Protocol population:Randomized subjects who received 1 of 3 consistency lots of HEPLISAV or Engerix-B within the study visit windows, had all 3 study injections as randomized and within the study visit windows, no major protocol deviations, and anti-HBs levels obtained within study visit windows at baseline, Week 12, and Week 32

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HEPLISAV and/or Placebo	78 of 1,968 (4%)	80 of 1,968 (4.1%)	Not reported
Engerix-B(1)	23 of 481 (4.8%)	25 of 481 (5.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23727002Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

32 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Engerix-B in people with Healthy, run by Dynavax Technologies Corporation at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Have a Seroprotective Immune Response (time frame: at Week 12 and at Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01005407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.