Trial Outcomes & Findings for Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine (NCT NCT00511095)

NCT ID: NCT00511095

Last Updated: 2019-04-30

Results Overview

Local and Systemic post-injection reactions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 207 participants
• Primary outcome timeframe: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
• Results posted on: 2019-04-30

Participant Flow

Participant milestones

Measure	HEPLISAV 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
Overall Study STARTED	207
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

Baseline characteristics by cohort

Measure	HEPLISAV n=207 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	207 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.0 years STANDARD_DEVIATION 8.36 • n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants
Region of Enrollment United States	207 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4

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

Local and Systemic post-injection reactions.

Outcome measures

Measure	HEPLISAV (Week 0) n=207 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0	HEPLISAV (Week 4) n=203 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4	HEPLISAV (Week 12) 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 12	HEPLISAV (Week 28) 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 28
Percentage of Participants With Local and Systemic Post-injection Reaction Rates Local Reaction: Injection	38.2 percentage of subjects	37.9 percentage of subjects	—	—
Percentage of Participants With Local and Systemic Post-injection Reaction Rates Systemic Reaction: Injection	37.2 percentage of subjects	33.0 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12 and 28

Population: Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.

Seroprotective Immune Response

Outcome measures

Measure	HEPLISAV (Week 0) n=205 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0	HEPLISAV (Week 4) n=199 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4	HEPLISAV (Week 12) n=198 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 12	HEPLISAV (Week 28) n=196 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 28
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.	32.7 percentage of subjects	84.9 percentage of subjects	93.4 percentage of subjects	95.4 percentage of subjects

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 28

Population: Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data. Note: "Number Analyzed" is the number of subjects with nonmissing concentrations at that visit.

Measurement of Serum GMC

Outcome measures

Measure	HEPLISAV (Week 0) n=207 Participants 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0	HEPLISAV (Week 4) 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 4	HEPLISAV (Week 12) 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 12	HEPLISAV (Week 28) 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 28
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 Week 4	11.5 mIU/mL Interval 7.8 to 16.8	—	—	—
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 Week 8	97.1 mIU/mL Interval 69.1 to 136.6	—	—	—
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 Week 12	170.7 mIU/mL Interval 127.9 to 227.7	—	—	—
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 Week 28	349.4 mIU/mL Interval 271.8 to 449.3	—	—	—

Adverse Events

HEPLISAV

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	HEPLISAV n=207 participants at risk 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
General disorders Hernia obstructive	0.48% 1/207
Hepatobiliary disorders Cholelithiasis	0.48% 1/207
Infections and infestations Urinary tract infection	0.48% 1/207
Injury, poisoning and procedural complications Postoperative ileus	0.48% 1/207
Metabolism and nutrition disorders Hypokalaemia	0.48% 1/207
Nervous system disorders Syncope	0.48% 1/207
Respiratory, thoracic and mediastinal disorders Hypoxia	0.48% 1/207

Other adverse events

Measure	HEPLISAV n=207 participants at risk 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 16/207
Musculoskeletal and connective tissue disorders Back pain	5.8% 12/207
Nervous system disorders Headache	15.0% 31/207

Additional Information

Robert Janssen MD \ VP & Chief Medical Officer

Dynavax Technologies, Inc.

Phone: 510-848-5100

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60