Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Study Details
Study Description
Brief Summary
This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult subjects in Russia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study was a comparative randomized double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in hepatitis B-naive healthy adult subjects (n = 100). The study was conducted at 3 study sites in the Russian Federation. Subjects who passed the screening successfully were randomized into two groups, Sci-B-Vac® (10 μg dose) and Engerix-B® (20 μg dose), in a 1:1 ratio. Subjects were vaccinated three times at days 1, 28, and 180 of the study.
Statistical Methods: Evaluation and comparison of immunogenicity were conducted at baseline, day 28, day 90 (60 days after the second vaccination), day 180 (prior to administering the third vaccine, 90 days after the second vaccination), and day 210 (30 days after the third vaccination) of the study.
The primary outcome was the seroconversion rate (proportion of subjects with anti-HBs levels ≥ 2.1 mIU/mL) after the third vaccination at day 210. The non-inferiority margin was set at 4%. The percentage of subjects who achieved seroconversion was analyzed using the Chi-square test for proportions along with the McNemar's test for repeated measurements in each group. The non-inferiority hypotheses were confirmed if the lower range of the confidence interval was at least -4%. The secondary endpoint was SPR (≥10 mIU/ml), measured at days 1, 28, 90, 180 and 210.
Demographic data, initial parameters, safety parameters, tolerance of the experimental vaccine, and other study parameters were analyzed using descriptive statistics (mean value, standard deviation, median, minimum and maximum values, range, quartiles, the number of valid cases-for quantitative variables; absolute number, proportion, allocation-for qualitative variables). A comparative assessment of the detection rate for different parameters in the two comparison groups was conducted using the Student's t-test; differences were considered statistically significant at a significance level of 5%. The assay used to measure anti-HBs concentrations had an upper limit of 1000 mIU/mL.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sci-B-Vac® The 3-antigen HepB vaccine, Sci-B-Vac® contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac® was supplied in 1.0 ml vials. |
Biological: Sci-B-Vac®
Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
|
| Active Comparator: Engerix-B® The single-antigen HepB vaccine, Engerix-B® (GSK), contains the small S recombinant protein. Engerix-B® was supplied in 1.0 ml vials. |
Biological: Engerix-B®
Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml
|
Outcome Measures
Primary Outcome Measures
- Seroconversion Rate [Day 210]
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL 30 days after the last of three vaccinations. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
Secondary Outcome Measures
- Seroprotection Rate [Days 1, 28, 90, 180, 210]
Percentage of subjects with an anti-HBs antibody level ≥ 10 mIU/mL prior to vaccination, 28 days after the first vaccination, 60 and 150 days after the second vaccination and 30 days after the third vaccination. The development of an anti-HBs antibody level of at least 10 mIU/mL is an established surrogate of seroprotection and correlate of protective immunity against HBV.
- Seroconversion Rate [Days 1, 28, 90, 180]
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL prior to vaccination, 28 days after the first vaccination and 60 and 150 days after the second vaccination. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
- Geometric Mean Concentrations (GMC) of HBs Antibodies [Days 1, 28, 90, 180, and 210]
Geometric mean concentration of anti-HBs antibody in mIU/mL 28 days after the first vaccination, 60 and 150 days after the second vaccination, and 30 days after the third vaccination.
Other Outcome Measures
- Adverse Events: Local Reactions at the Injection Site- Incidence of Redness [Day 1, Day 2, and Day 28]
Incidence of mild erythema at the injection site 1, 2 and 28 days after the first vaccination.
- Adverse Events: Local Reactions at the Injection Site - Incidence of Itch [Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210]
Incidence of itchiness at the injection site at any point throughout the trial. Itchiness was assessed for 5 days following vaccinations on Days 1, 28, and 180 and also assessed on Day 90 and Day 210.
- Adverse Events: Local Reactions at the Injection Site - Incidence of Pain [Days 1, 28, 180]
Incidence of pain at the injection site on the day of vaccination. Vaccination was performed on Day 1, Day 28, and Day 180.
- Adverse Events: Local Reactions at the Injection Site - Intensity of Pain [Days 1, 28, 180]
Pain was evaluated 30 minutes after each vaccination by the subject using the visual analogue scale. A higher score indicates greater pain intensity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Availability of written Informed Consent to participate in the study from the subject.
-
Male or female between 18 and 45 years old without previous contact with hepatitis B virus (HBV).
-
Good health condition based on full physical examination.
-
Normal values of laboratory biochemical blood tests.
-
Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core) antibodies, and HBs Antigen (HBsAg) on screening.
-
Not pregnant and not breast-feeding.
-
For men and women of reproductive age: consent for use of an effective contraception method, for example, an intrauterine device, oral contraceptive, hypodermic implant or double barrier method (a condom with contraceptive sponge or contraceptive suppository) throughout the entire study.
Exclusion Criteria:
-
Congenital or inherited immunodeficiency disorder in family history.
-
Information of a serious blood disorder, cardiac disorder, or tumour.
-
Current use of any medication that could alter immune reactivity.
-
Infection with HBV at the present time or in the past, confirmed by HBV markers test.
-
Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.
-
Pregnancy and breast-feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Petersburg State Budgetary Healthcare Institution | Saint Petersburg | Mirgorodskaya | Russian Federation | 191167 |
Sponsors and Collaborators
- VBI Vaccines Inc.
Investigators
- Principal Investigator: Elena Esaulenko, Saint Petersburg State Paediatric Medical University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 38-13-040 RUS
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 1, 28 and 180 Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Period Title: Overall Study | ||
| STARTED | 50 | 50 |
| COMPLETED | 50 | 49 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Sci-B-Vac® | Engerix-B® | Total |
|---|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Total of all reporting groups |
| Overall Participants | 50 | 50 | 100 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
50
100%
|
50
100%
|
100
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
28.38
(7.72)
|
30.56
(8.13)
|
29.47
(7.96)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
32
64%
|
29
58%
|
61
61%
|
| Male |
18
36%
|
21
42%
|
39
39%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian-Russians |
50
100%
|
50
100%
|
100
100%
|
| Region of Enrollment (Count of Participants) | |||
| Russia |
50
100%
|
50
100%
|
100
100%
|
Outcome Measures
| Title | Seroconversion Rate |
|---|---|
| Description | Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL 30 days after the last of three vaccinations. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL. |
| Time Frame | Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 47 | 47 |
| Count of Participants [Participants] |
47
94%
|
46
92%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sci-B-Vac®, Engerix-B® |
|---|---|---|
| Comments | The null hypothesis is that the vaccines equally affect the achievement of seroconversion level. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | P < 0.05 is considered a statistically significant difference in seroconversion between the two groups. | |
| Statistical Test of Hypothesis | p-Value | 1 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Seroprotection Rate |
|---|---|
| Description | Percentage of subjects with an anti-HBs antibody level ≥ 10 mIU/mL prior to vaccination, 28 days after the first vaccination, 60 and 150 days after the second vaccination and 30 days after the third vaccination. The development of an anti-HBs antibody level of at least 10 mIU/mL is an established surrogate of seroprotection and correlate of protective immunity against HBV. |
| Time Frame | Days 1, 28, 90, 180, 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 1 |
0
0%
|
0
0%
|
| Day 28 |
30
60%
|
24
48%
|
| Day 90 |
47
94%
|
41
82%
|
| Day 180 |
47
94%
|
42
84%
|
| Title | Seroconversion Rate |
|---|---|
| Description | Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL prior to vaccination, 28 days after the first vaccination and 60 and 150 days after the second vaccination. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL. |
| Time Frame | Days 1, 28, 90, 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 1 |
0
0%
|
0
0%
|
| Day 28 |
46
92%
|
36
72%
|
| Day 90 |
48
96%
|
45
90%
|
| Day 180 |
47
94%
|
45
90%
|
| Title | Geometric Mean Concentrations (GMC) of HBs Antibodies |
|---|---|
| Description | Geometric mean concentration of anti-HBs antibody in mIU/mL 28 days after the first vaccination, 60 and 150 days after the second vaccination, and 30 days after the third vaccination. |
| Time Frame | Days 1, 28, 90, 180, and 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 90 |
618.3
(404.2)
|
378.7
(417.9)
|
| Day 180 |
757.7
(378.0)
|
441.3
(437.6)
|
| Day 210 |
891.4
(253.7)
|
787.0
(351.9)
|
| Title | Adverse Events: Local Reactions at the Injection Site- Incidence of Redness |
|---|---|
| Description | Incidence of mild erythema at the injection site 1, 2 and 28 days after the first vaccination. |
| Time Frame | Day 1, Day 2, and Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 1 |
8
16%
|
4
8%
|
| Day 2 |
2
4%
|
1
2%
|
| Day 28 |
3
6%
|
0
0%
|
| Title | Adverse Events: Local Reactions at the Injection Site - Incidence of Itch |
|---|---|
| Description | Incidence of itchiness at the injection site at any point throughout the trial. Itchiness was assessed for 5 days following vaccinations on Days 1, 28, and 180 and also assessed on Day 90 and Day 210. |
| Time Frame | Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Count of Participants [Participants] |
1
2%
|
0
0%
|
| Title | Adverse Events: Local Reactions at the Injection Site - Incidence of Pain |
|---|---|
| Description | Incidence of pain at the injection site on the day of vaccination. Vaccination was performed on Day 1, Day 28, and Day 180. |
| Time Frame | Days 1, 28, 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 1 |
7
14%
|
8
16%
|
| Day 28 |
8
16%
|
7
14%
|
| Day 180 |
7
14%
|
11
22%
|
| Title | Adverse Events: Local Reactions at the Injection Site - Intensity of Pain |
|---|---|
| Description | Pain was evaluated 30 minutes after each vaccination by the subject using the visual analogue scale. A higher score indicates greater pain intensity. |
| Time Frame | Days 1, 28, 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine. |
| Arm/Group Title | Sci-B-Vac® | Engerix-B® |
|---|---|---|
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination |
| Measure Participants | 50 | 49 |
| Day 1 : Pains score 1 |
43
86%
|
41
82%
|
| Day 1 : Pain score 2 |
5
10%
|
6
12%
|
| Day 1 : Pain score 3 |
2
4%
|
2
4%
|
| Day 28 : Pain score 1 |
42
84%
|
41
82%
|
| Day 28 : Pain score 2 |
7
14%
|
6
12%
|
| Day 28 : Pain score 3 |
1
2%
|
1
2%
|
| Day 180 : Pain score 1 |
40
80%
|
36
72%
|
| Day 180 : Pain score 2 |
7
14%
|
9
18%
|
| Day 180 : Pain score 3 |
0
0%
|
2
4%
|
Adverse Events
| Time Frame | Through study completion, approximately 7 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity | |||
| Arm/Group Title | Sci-B-Vac® | Engerix-B® | ||
| Arm/Group Description | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | ||
All Cause Mortality |
||||
| Sci-B-Vac® | Engerix-B® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/49 (0%) | ||
Serious Adverse Events |
||||
| Sci-B-Vac® | Engerix-B® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/49 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sci-B-Vac® | Engerix-B® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/50 (4%) | 7/49 (14.3%) | ||
| Gastrointestinal disorders | ||||
| nausea | 0/50 (0%) | 0 | 1/49 (2%) | 2 |
| General disorders | ||||
| Hyperthermia | 0/50 (0%) | 0 | 1/49 (2%) | 1 |
| Hepatobiliary disorders | ||||
| steatohepatitis | 0/50 (0%) | 0 | 1/49 (2%) | 1 |
| Infections and infestations | ||||
| acute respiratory viral infection | 0/50 (0%) | 0 | 1/49 (2%) | 3 |
| rotavirus infection | 0/50 (0%) | 0 | 1/49 (2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| weakness | 0/50 (0%) | 0 | 1/49 (2%) | 1 |
| Nervous system disorders | ||||
| drowsiness | 2/50 (4%) | 3 | 2/49 (4.1%) | 2 |
| metallic taste | 0/50 (0%) | 0 | 1/49 (2%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr Francisco Diaz-Mitoma |
|---|---|
| Organization | VBI Vaccines Inc. |
| Phone | 613-297-3304 |
| fdiazmitoma@vbivaccines.com |
- 38-13-040 RUS