HealthyPhase 3NCT02117934

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

A Phase 3 study testing HEPLISAV and Engerix-B in people with Healthy, run by Dynavax Technologies Corporation at 40 sites in United States.

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 and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HEPLISAV and Engerix-B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8,374 participants
Where: 40 sitesUnited States
Study dates: Apr 2014to Oct 2015
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be 18-70 years of age, inclusive
Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
Able and willing to provide informed consent
A subject with any one of the following criteria is not eligible for the trial:

Who cannot join

Previous receipt of any hepatitis B vaccine
History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
History of autoimmune disorder
History of sensitivity to any component of study vaccines
Has received the following prior to the first injection:
Within 28 days:

Show all 15Show fewer

Any vaccine
Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
Any other investigational medicinal agent
Within 90 days: Blood products or immunoglobulin
At any time: An injection of DNA plasmids or oligonucleotide
If female: Pregnant, nursing, or planning to become pregnant during the trial
Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Radiant Research
Akron, Ohio, 44311
Clinical Research Advantage, Inc.
Anderson, South Carolina, 29621
Radiant Research
Anderson, South Carolina, 29621
Radiant Research
Atlanta, Georgia, 30342
Clinical Research Advantage, Inc.
Birmingham, Alabama, 35211
Clinical Research Advantage, Inc.
Centennial, Colorado, 80112
Clinical Research Advantage, Inc.
Chandler, Arizona, 85224
Radiant Research
Chandler, Arizona, 85224
Radiant Research
Chicago, Illinois, 60654
Radiant Research
Cincinnati, Ohio, 45249
Clinical Research Advantage, Inc.
Colorado Springs, Colorado, 80922
Radiant Research
Columbus, Ohio, 43212
Clinical Research Advantage, Inc.
Council Bluffs, Iowa, 51503
Radiant Research
Dallas, Texas, 75231
Radiant Research
Denver, Colorado, 80239
Radiant Research
Edina, Minnesota, 55435
Clinical Research Advantage, Inc.
Elkhorn, Nebraska, 68022
Clinical Research Advantage, Inc
Evansville, Indiana, 47725
Clinical Research Advantage, Inc.
Fremont, Nebraska, 68025
Clinical Research Advantage, Inc.
Glendale, Arizona, 85306
Radiant Research
Greer, South Carolina, 29650
Clinical Research Advantage, Inc.
Henderson, Nevada, 89052
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128
Clinical Research Advantage, Inc.
Mesa, Arizona, 85206
Clinical Research Advantage, Inc.
Mesa, Arizona, 85213
Radiant Research
Murray, Utah, 84123
Clinical Research Advantage, Inc.
Omaha, Nebraska, 68124
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85018
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85020
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85050
Radiant Research
Pinellas Park, Florida, 33781
Clinical Research Advantage, Inc.
Plano, Texas, 75093
Radiant Research
San Antonio, Texas, 78229
Radiant Research
Santa Rosa, California, 95405
Radiant Research
Scottsdale, Arizona, 85251
Radiant Research
St Louis, Missouri, 83141
Clinical Research Advantage, Inc.
Tempe, Arizona, 85283
Radiant Research
Tucson, Arizona, 85712
Clinical Research Advantage, Inc.
Tucson, Arizona, 85741
Clinical Research Advantage, Inc.
Vista, California, 92083

Other trials in United States

About this study

Official title: A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.

Conditions: Healthy
Being tested: HEPLISAV, Engerix-B
Keywords: HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and 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.

HEPLISAVBiological
Also called Hepatitis B vaccine (recombinant), adjuvanted, HEPLISAV-B
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Engerix-BBiological
Also called Hepatitis B vaccine (recombinant)
Intramuscular injections at Week 0, Week 4, and Week 24

Study groups in NCT02117934
Study group	Role	What they receive
HEPLISAV	Experimental	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV. Receives: Biological: HEPLISAV
Engerix-B	Active comparator	1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of 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 Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Measured: Week 56
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
Measured: Week 28

Timeline

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

Apr 2014Oct 2015

First posted21 Apr 2014 (estimated)
Study startApr 2014
Primary completionOct 2015
Study completionOct 2015

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 (2)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: 8,374 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02117934
Sponsor's protocol ID: DV2-HBV-23
Status last verified: Mar 2019
First submitted: 15 Apr 2014
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

Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
PubMed 31431412
Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
PubMed 29289383

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?

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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: A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
ClinicalTrials.gov ID: NCT02117934
Acronym / sponsor ID: DV2-HBV-23
Conditions: Healthy
Keywords: HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and Control, Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,374 participants (actual)
Lead sponsor: Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 10 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 and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 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	Experimental	Biological: HEPLISAV0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
Engerix-B	Active comparator	Biological: Engerix-B1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be 18-70 years of age, inclusive
Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
Able and willing to provide informed consent

Key exclusion criteria (15 listed)

Previous receipt of any hepatitis B vaccine
History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
History of autoimmune disorder
History of sensitivity to any component of study vaccines
Has received the following prior to the first injection:

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
HEPLISAVAlso: Hepatitis B vaccine (recombinant), adjuvanted, HEPLISAV-BIntramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24	Biological	HEPLISAV
Engerix-BAlso: Hepatitis B vaccine (recombinant)Intramuscular injections at Week 0, Week 4, and Week 24	Biological	Engerix-B

Primary outcome

Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Time frame: Week 56
The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
Time frame: Week 28
Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B

Results and safety

Results posted to the registry on 10 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	5,592	5,092
Engerix-B	2,782	2,567

Primary outcome: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest

Time frame: Week 56. Number. Unit: percentage of participants

Measure	HEPLISAV n = 5587	Engerix-B n = 2781
New-onset Immune-mediated Adverse Events	0.1	0.04
Medically-attended Adverse Events	46.0	46.2
Serious Adverse Events	6.2	5.3

Population analysed: Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data

Primary outcome: Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response

Time frame: Week 28. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	HEPLISAV n = 640	Engerix-B n = 321
Value	90.0 (87.4 to 92.2)	65.1 (59.6 to 70.3)

Population analysed: Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.

Adverse events

Time frame: Through Week 56. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HEPLISAV	345 of 5,587 (6.2%)	1,097 of 5,587 (19.6%)	Not reported
Engerix-B	148 of 2,781 (5.3%)	549 of 2,781 (19.7%)	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 31431412Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
Derived from this study: PubMed 29289383Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
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.

Robert Janssen, MD study director

Dynavax Technologies Corporation

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HEPLISAV and Engerix-B in people with Healthy, run by Dynavax Technologies Corporation at 40 sites in United States.

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 5 inclusion and 15 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 40 sites in United States. 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 10 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 Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest (time frame: Week 56). The study lists 2 primary outcomes in all. 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 NCT02117934, which also lists 2 linked publications.

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.