Trial Outcomes & Findings for A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults (NCT NCT04531098)

Last Updated: 2022-07-26

Results Overview

Percentage of participants with an antibody response to hepatitis B surface antigens (anti-HBs), defined as an anti-HBs titer ≥10 IU/liter, one month after the third vaccination (Day 210) in the According-to-Protocol (ATP) population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

402 participants

Primary outcome timeframe

Day 210

Results posted on

2022-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sci-B-Vac-Lot B The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Stage I STARTED	0	67	134
Stage I COMPLETED	0	62	116
Stage I NOT COMPLETED	0	5	18
Stage II STARTED	134	67	0
Stage II COMPLETED	121	57	0
Stage II NOT COMPLETED	13	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sci-B-Vac-Lot B The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Stage I Adverse Event	0	0	3
Stage I Protocol Violation	0	0	5
Stage I Withdrawal by Subject	0	5	10
Stage II Adverse Event	1	2	0
Stage II Protocol Violation	1	2	0
Stage II Withdrawal by Subject	3	1	0
Stage II Moved from study area	8	5	0

Baseline Characteristics

Available Observations

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 210

Population: The according-to-protocol (ATP) population included all participants who received the three vaccinations, the third vaccination measurement of anti-HBs titers, and had no major protocol violations.

Outcome measures

Outcome measures
Measure	Sci-B-Vac-Lot B n=120 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=117 Participants The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=112 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination	120 Participants	115 Participants	109 Participants

SECONDARY outcome

Timeframe: Days 180, 210, and 360

Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥10 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.

Outcome measures

Outcome measures
Measure	Sci-B-Vac-Lot B n=120 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=117 Participants The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=112 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. Day 180	118 Participants	95 Participants	102 Participants
Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. Day 210	120 Participants	115 Participants	109 Participants
Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. Day 360	115 Participants	110 Participants	101 Participants

SECONDARY outcome

Timeframe: Days 180, 210, and 360

Geometric mean concentration (GMC) of anti-HBs antibody just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.

Outcome measures

Outcome measures
Measure	Sci-B-Vac-Lot B n=120 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=117 Participants The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=112 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Anti-HBs Geometric Mean Concentration (GMC) Day 180	328.64 IU/Liter Interval 237.01 to 455.69	44.42 IU/Liter Interval 31.9 to 61.85	147.30 IU/Liter Interval 105.02 to 206.6
Anti-HBs Geometric Mean Concentration (GMC) Day 210	12,158.94 IU/Liter Interval 8666.37 to 17059.02	4,124.24 IU/Liter Interval 2926.93 to 5811.33	3,587.30 IU/Liter Interval 2526.67 to 5093.16
Anti-HBs Geometric Mean Concentration (GMC) Day 360	3188.68 IU/Liter Interval 2249.17 to 4520.63	991.07 IU/Liter Interval 694.76 to 1413.77	1239.82 IU/Liter Interval 859.07 to 1789.33

SECONDARY outcome

Timeframe: Days 180, 210 and 360

Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥100 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.

Outcome measures

Outcome measures
Measure	Sci-B-Vac-Lot B n=120 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=117 Participants The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=112 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. Day 180	99 Participants	40 Participants	68 Participants
Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. Day 210	118 Participants	113 Participants	106 Participants
Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. Day 360	113 Participants	100 Participants	94 Participants

Adverse Events

Sci-B-Vac-Lot B

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

Engerix-B

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Sci-B-Vac-Lot A

Serious events: 3 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sci-B-Vac-Lot B n=131 participants at risk The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=133 participants at risk The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=134 participants at risk The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
Psychiatric disorders schizophrenia	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/134 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Injury, poisoning and procedural complications ilium fracture	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/134 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Musculoskeletal and connective tissue disorders osteitis	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/134 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Vascular disorders Circulatory collapse	0.76% 1/131 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Infections and infestations hepatitis B	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Infections and infestations gastritis	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Blood and lymphatic system disorders anemia	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders pyrexia	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Number of events 1 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.

Other adverse events

Other adverse events
Measure	Sci-B-Vac-Lot B n=131 participants at risk The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=133 participants at risk The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=134 participants at risk The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml
General disorders Injection site pain	43.5% 57/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	14.3% 19/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	59.0% 79/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Musculoskeletal and connective tissue disorders Myalgia	12.2% 16/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	2.3% 3/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	13.4% 18/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Fatigue	7.6% 10/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	4.5% 6/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	10.4% 14/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Malaise	2.3% 3/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	3.0% 4/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	9.0% 12/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Injection site pruritus	3.1% 4/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	2.3% 3/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	5.2% 7/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Pyrexia	0.76% 1/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	1.5% 2/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 2/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	3.0% 4/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Skin and subcutaneous tissue disorders Pruritus	0.76% 1/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	2.3% 3/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	2.2% 3/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Cardiac disorders Dizziness	0.76% 1/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
Vascular disorders Circulatory collapse	0.76% 1/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Injection site swelling	0.76% 1/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
General disorders Feeling hot	0.00% 0/131 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.75% 1/133 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.	0.00% 0/134 • Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310). Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.

Additional Information

Dr. Francisco Diaz-Mitoma

VBI Vaccines

Phone: 1 613 297 3304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sci-B-Vac-Lot B n=131 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Engerix-B n=133 Participants The mono-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.	Sci-B-Vac-Lot A n=134 Participants The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml	Total n=398 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Available Observations	0 Participants n=7 Participants • Available Observations	0 Participants n=5 Participants • Available Observations	0 Participants n=4 Participants • Available Observations
Age, Categorical Between 18 and 65 years	131 Participants n=5 Participants • Available Observations	133 Participants n=7 Participants • Available Observations	134 Participants n=5 Participants • Available Observations	398 Participants n=4 Participants • Available Observations
Age, Categorical >=65 years	0 Participants n=5 Participants • Available Observations	0 Participants n=7 Participants • Available Observations	0 Participants n=5 Participants • Available Observations	0 Participants n=4 Participants • Available Observations
Age, Continuous	20.58 years STANDARD_DEVIATION 1.577 • n=5 Participants • Available Observations	20.48 years STANDARD_DEVIATION 1.655 • n=7 Participants • Available Observations	20.79 years STANDARD_DEVIATION 2.392 • n=5 Participants • Available Observations	20.62 years STANDARD_DEVIATION 1.913 • n=4 Participants • Available Observations
Sex: Female, Male Female	94 Participants n=5 Participants • Available Observations	89 Participants n=7 Participants • Available Observations	89 Participants n=5 Participants • Available Observations	272 Participants n=4 Participants • Available Observations
Sex: Female, Male Male	37 Participants n=5 Participants • Available Observations	44 Participants n=7 Participants • Available Observations	45 Participants n=5 Participants • Available Observations	126 Participants n=4 Participants • Available Observations
Region of Enrollment Vietnam	131 Participants n=5 Participants	133 Participants n=7 Participants	134 Participants n=5 Participants	398 Participants n=4 Participants
Ethnic Group White/Caucasian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnic Group Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnic Group Asian	131 Participants n=5 Participants	133 Participants n=7 Participants	134 Participants n=5 Participants	398 Participants n=4 Participants
Ethnic Group Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Weight	50.2 kg STANDARD_DEVIATION 5.9 • n=5 Participants	50.2 kg STANDARD_DEVIATION 7.3 • n=7 Participants	51.8 kg STANDARD_DEVIATION 6.0 • n=5 Participants	50.8 kg STANDARD_DEVIATION 6.5 • n=4 Participants
Body Mass Index	20.1 kg/m^2 STANDARD_DEVIATION 1.5 • n=5 Participants	20.0 kg/m^2 STANDARD_DEVIATION 2.2 • n=7 Participants	20.9 kg/m^2 STANDARD_DEVIATION 1.9 • n=5 Participants	20.3 kg/m^2 STANDARD_DEVIATION 1.9 • n=4 Participants
Smoking status Smoker	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Smoking status Non-smoker	128 Participants n=5 Participants	127 Participants n=7 Participants	133 Participants n=5 Participants	388 Participants n=4 Participants