Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Sponsor
VBI Vaccines Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02826798
Collaborator
Clinical Trial Data Services, LLC (Other)
128
3
5
14
42.7
3
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.
Study Design
Study Type:
Interventional
Actual Enrollment
:
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Candidate Human Cytomegalovirus Vaccine (VBI-1501) in Healthy Adults
Actual Study Start Date
:
Jun 23, 2016
Actual Primary Completion Date
:
Sep 15, 2016
Actual Study Completion Date
:
Aug 24, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VBI-1501A: 0.5µg with adjuvant 0.5µg CMV vaccine with adjuvant |
Drug: VBI-1501A 0.5 μg
VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
| Experimental: VBI-1501A: 1.0µg with adjuvant 1.0µg CMV vaccine with adjuvant |
Drug: VBI-1501A 1.0 μg
VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
| Experimental: VBI-1501A: 2.0 µg with adjuvant 2.0 µg CMV vaccine with adjuvant |
Drug: VBI-1501A 2.0 μg
VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
| Experimental: VBI-1501: 1.0µg without adjuvant 1.0µg CMV vaccine without adjuvant |
Drug: VBI-1501 1.0 μg
VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
|
| Placebo Comparator: Placebo Buffer/sucrose used for VBI-1501 suspension |
Drug: Placebo
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period [Day of vaccine administration (days 0, 56, 168) and six subsequent days]
- Number of Participants With Any Adverse Event [Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.]
- Number of Participants With Any Serious Adverse Event [Through Day 336 or early withdrawal]
- Number of Participants With Any Hematological or Biochemical Laboratory Abnormality [Through Day 336 or early withdrawal]
Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.
Secondary Outcome Measures
- Geometric Mean Titer of Antibody Binding to CMV gB [Through Day 336 or early withdrawal]
- Geometric Mean Titer of Antibody Avidity Index Value Against gB [Through Day 336 or early withdrawal]
To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea.
- Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells [Through Day 196 or early withdrawal]
- Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells [Through Day 336 or early withdrawal]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Generally healthy adult female and male 18 to 40 years of age, inclusive;
-
Serologically confirmed to be CMV seronegative at screening;
-
Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
-
Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study
Exclusion Criteria:
-
History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
-
Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
-
Previous receipt of any cytomegalovirus vaccine
-
History of allergic reactions or anaphylactic reaction to any vaccine component
-
Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
-
Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
-
Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
-
Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
-
Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
-
Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
-
Are family members of study center staff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vaccine Evaluation Center | Vancouver | British Columbia | Canada | V5Z 4H4 |
| 2 | Canadian Center for Vaccinology; IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 3 | McGill University Health Centre - Vaccine Study | Pierrefonds | Quebec | Canada | H9H 4Y6 |
Sponsors and Collaborators
- VBI Vaccines Inc.
- Clinical Trial Data Services, LLC
Investigators
- Principal Investigator: Joanne Langley, MD, IWK Health Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- 15. Paneque-Quevedo AA. Inorganic compounds as vaccine adjuvants. Biotecnología Aplicada. 2013;30:250-256.
- Adler SP, Starr SE, Plotkin SA, Hempfling SH, Buis J, Manning ML, Best AM. Immunity induced by primary human cytomegalovirus infection protects against secondary infection among women of childbearing age. J Infect Dis. 1995 Jan;171(1):26-32. Erratum in: J Infect Dis 1995 Apr;171(4):1080.
- Adler SP. Human CMV vaccine trials: what if CMV caused a rash? J Clin Virol. 2008 Mar;41(3):231-6. Epub 2007 Dec 21. Review.
- Axelsson F, Adler SP, Lamarre A, Ohlin M. Humoral immunity targeting site I of antigenic domain 2 of glycoprotein B upon immunization with different cytomegalovirus candidate vaccines. Vaccine. 2007 Dec 21;26(1):41-6. Epub 2007 Nov 9.
- Baylor NW, Egan W, Richman P. Aluminum salts in vaccines--US perspective. Vaccine. 2002 May 31;20 Suppl 3:S18-23. Review. Erratum in: Vaccine. 2002 Sep 10;20(27-28):3428.
- Biffi A, Montini E, Lorioli L, Cesani M, Fumagalli F, Plati T, Baldoli C, Martino S, Calabria A, Canale S, Benedicenti F, Vallanti G, Biasco L, Leo S, Kabbara N, Zanetti G, Rizzo WB, Mehta NA, Cicalese MP, Casiraghi M, Boelens JJ, Del Carro U, Dow DJ, Schmidt M, Assanelli A, Neduva V, Di Serio C, Stupka E, Gardner J, von Kalle C, Bordignon C, Ciceri F, Rovelli A, Roncarolo MG, Aiuti A, Sessa M, Naldini L. Lentiviral hematopoietic stem cell gene therapy benefits metachromatic leukodystrophy. Science. 2013 Aug 23;341(6148):1233158. doi: 10.1126/science.1233158. Epub 2013 Jul 11.
- FDA Guidance for industry (Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical studies, September 2007. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091977.pdf.
- Fishman JA, Emery V, Freeman R, Pascual M, Rostaing L, Schlitt HJ, Sgarabotto D, Torre-Cisneros J, Uknis ME. Cytomegalovirus in transplantation - challenging the status quo. Clin Transplant. 2007 Mar-Apr;21(2):149-58. Review.
- Fu TM, Wang D, Freed DC, Tang A, Li F, He X, Cole S, Dubey S, Finnefrock AC, ter Meulen J, Shiver JW, Casimiro DR. Restoration of viral epithelial tropism improves immunogenicity in rabbits and rhesus macaques for a whole virion vaccine of human cytomegalovirus. Vaccine. 2012 Dec 14;30(52):7469-74. doi: 10.1016/j.vaccine.2012.10.053. Epub 2012 Oct 26.
- Gordon EM, Levy JP, Reed RA, Petchpud WN, Liu L, Wendler CB, Hall FL. Targeting metastatic cancer from the inside: a new generation of targeted gene delivery vectors enables personalized cancer vaccination in situ. Int J Oncol. 2008 Oct;33(4):665-75.
- Griffiths PD, Stanton A, McCarrell E, Smith C, Osman M, Harber M, Davenport A, Jones G, Wheeler DC, O'Beirne J, Thorburn D, Patch D, Atkinson CE, Pichon S, Sweny P, Lanzman M, Woodford E, Rothwell E, Old N, Kinyanjui R, Haque T, Atabani S, Luck S, Prideaux S, Milne RS, Emery VC, Burroughs AK. Cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant in transplant recipients: a phase 2 randomised placebo-controlled trial. Lancet. 2011 Apr 9;377(9773):1256-63. doi: 10.1016/S0140-6736(11)60136-0.
- Hacein-Bey-Abina S, Pai SY, Gaspar HB, Armant M, Berry CC, Blanche S, Bleesing J, Blondeau J, de Boer H, Buckland KF, Caccavelli L, Cros G, De Oliveira S, Fernández KS, Guo D, Harris CE, Hopkins G, Lehmann LE, Lim A, London WB, van der Loo JC, Malani N, Male F, Malik P, Marinovic MA, McNicol AM, Moshous D, Neven B, Oleastro M, Picard C, Ritz J, Rivat C, Schambach A, Shaw KL, Sherman EA, Silberstein LE, Six E, Touzot F, Tsytsykova A, Xu-Bayford J, Baum C, Bushman FD, Fischer A, Kohn DB, Filipovich AH, Notarangelo LD, Cavazzana M, Williams DA, Thrasher AJ. A modified γ-retrovirus vector for X-linked severe combined immunodeficiency. N Engl J Med. 2014 Oct 9;371(15):1407-17. doi: 10.1056/NEJMoa1404588.
- Institute of Medicine (US) Committee to Study Priorities for Vaccine Development; Stratton KR, Durch JS, Lawrence RS, editors. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington (DC): National Academies Press (US); 2000.
- Loomis RJ, Lilja AE, Monroe J, Balabanis KA, Brito LA, Palladino G, Franti M, Mandl CW, Barnett SW, Mason PW. Vectored co-delivery of human cytomegalovirus gH and gL proteins elicits potent complement-independent neutralizing antibodies. Vaccine. 2013 Jan 30;31(6):919-26. doi: 10.1016/j.vaccine.2012.12.009. Epub 2012 Dec 14.
- Macagno A, Bernasconi NL, Vanzetta F, Dander E, Sarasini A, Revello MG, Gerna G, Sallusto F, Lanzavecchia A. Isolation of human monoclonal antibodies that potently neutralize human cytomegalovirus infection by targeting different epitopes on the gH/gL/UL128-131A complex. J Virol. 2010 Jan;84(2):1005-13. doi: 10.1128/JVI.01809-09. Epub 2009 Nov 4.
- Pass RF, Duliegè AM, Boppana S, Sekulovich R, Percell S, Britt W, Burke RL. A subunit cytomegalovirus vaccine based on recombinant envelope glycoprotein B and a new adjuvant. J Infect Dis. 1999 Oct;180(4):970-5.
- Pass RF, Zhang C, Evans A, Simpson T, Andrews W, Huang ML, Corey L, Hill J, Davis E, Flanigan C, Cloud G. Vaccine prevention of maternal cytomegalovirus infection. N Engl J Med. 2009 Mar 19;360(12):1191-9. doi: 10.1056/NEJMoa0804749.
- Plotkin SA. Is there a formula for an effective CMV vaccine? J Clin Virol. 2002 Aug;25 Suppl 2:S13-21. Review.
- Zydek M, Petitt M, Fang-Hoover J, Adler B, Kauvar LM, Pereira L, Tabata T. HCMV infection of human trophoblast progenitor cells of the placenta is neutralized by a human monoclonal antibody to glycoprotein B and not by antibodies to the pentamer complex. Viruses. 2014 Mar 19;6(3):1346-64. doi: 10.3390/v6031346.
Responsible Party:
VBI Vaccines Inc.
ClinicalTrials.gov Identifier:
NCT02826798
Other Study ID Numbers:
- VBI-1501
First Posted:
Jul 11, 2016
Last Update Posted:
Apr 20, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by VBI Vaccines Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy cytomegalovirus (CMV)-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Period Title: Overall Study | |||||
| STARTED | 25 | 26 | 26 | 25 | 26 |
| COMPLETED | 25 | 25 | 26 | 24 | 26 |
| NOT COMPLETED | 0 | 1 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Total of all reporting groups |
| Overall Participants | 25 | 26 | 26 | 25 | 26 | 128 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (standard deviation) |
26.4
(4.58)
|
27.0
(5.38)
|
26.5
(4.60)
|
26.8
(5.99)
|
28.3
(5.58)
|
27.0
(5.22)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
12
48%
|
18
69.2%
|
17
65.4%
|
14
56%
|
15
57.7%
|
76
59.4%
|
| Male |
13
52%
|
8
30.8%
|
9
34.6%
|
11
44%
|
11
42.3%
|
52
40.6%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||
| North American Indian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White, Caucasian |
22
88%
|
24
92.3%
|
23
88.5%
|
22
88%
|
24
92.3%
|
115
89.8%
|
| Chinese |
2
8%
|
1
3.8%
|
0
0%
|
1
4%
|
1
3.8%
|
5
3.9%
|
| Black |
0
0%
|
0
0%
|
0
0%
|
1
4%
|
0
0%
|
1
0.8%
|
| Filipino |
0
0%
|
1
3.8%
|
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
| West Asian |
0
0%
|
0
0%
|
1
3.8%
|
0
0%
|
0
0%
|
1
0.8%
|
| Alaskan Native |
0
0%
|
0
0%
|
1
3.8%
|
0
0%
|
0
0%
|
1
0.8%
|
| Other |
1
4%
|
0
0%
|
1
3.8%
|
1
4%
|
1
3.8%
|
4
3.1%
|
| Region of Enrollment (participants) [Number] | ||||||
| Canada |
25
100%
|
26
100%
|
26
100%
|
25
100%
|
26
100%
|
128
100%
|
Outcome Measures
| Title | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period |
|---|---|
| Description | |
| Time Frame | Day of vaccine administration (days 0, 56, 168) and six subsequent days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Pain at injection site, Dose 1 |
11
44%
|
14
53.8%
|
13
50%
|
5
20%
|
3
11.5%
|
| Pain at injection site, Dose 2 |
10
40%
|
15
57.7%
|
14
53.8%
|
5
20%
|
4
15.4%
|
| Pain at injection site, Dose 3 |
10
40%
|
13
50%
|
13
50%
|
4
16%
|
3
11.5%
|
| Fatigue, Dose 1 |
9
36%
|
8
30.8%
|
5
19.2%
|
11
44%
|
6
23.1%
|
| Fatigue, Dose 2 |
9
36%
|
7
26.9%
|
8
30.8%
|
8
32%
|
3
11.5%
|
| Fatigue, Dose 3 |
10
40%
|
7
26.9%
|
7
26.9%
|
7
28%
|
3
11.5%
|
| Diarrhea, Dose 1 |
6
24%
|
4
15.4%
|
2
7.7%
|
4
16%
|
3
11.5%
|
| Diarrhea, Dose 2 |
2
8%
|
3
11.5%
|
1
3.8%
|
0
0%
|
1
3.8%
|
| Diarrhea, Dose 3 |
2
8%
|
1
3.8%
|
3
11.5%
|
2
8%
|
0
0%
|
| Nausea/Vomiting, Dose 1 |
4
16%
|
2
7.7%
|
2
7.7%
|
2
8%
|
1
3.8%
|
| Nausea/Vomiting, Dose 2 |
2
8%
|
4
15.4%
|
4
15.4%
|
0
0%
|
0
0%
|
| Nausea/Vomiting, Dose 3 |
1
4%
|
2
7.7%
|
3
11.5%
|
0
0%
|
0
0%
|
| Headache, Dose 1 |
9
36%
|
11
42.3%
|
7
26.9%
|
10
40%
|
7
26.9%
|
| Headache, Dose 2 |
11
44%
|
8
30.8%
|
10
38.5%
|
10
40%
|
2
7.7%
|
| Headache, Dose 3 |
7
28%
|
12
46.2%
|
9
34.6%
|
10
40%
|
5
19.2%
|
| Malaise, Dose 1 |
8
32%
|
7
26.9%
|
4
15.4%
|
7
28%
|
4
15.4%
|
| Malaise, Dose 2 |
5
20%
|
8
30.8%
|
7
26.9%
|
3
12%
|
3
11.5%
|
| Malaise, Dose 3 |
5
20%
|
6
23.1%
|
4
15.4%
|
4
16%
|
2
7.7%
|
| Myalgia, Dose 1 |
6
24%
|
11
42.3%
|
1
3.8%
|
4
16%
|
3
11.5%
|
| Myalgia, Dose 2 |
2
8%
|
8
30.8%
|
3
11.5%
|
3
12%
|
1
3.8%
|
| Myalgia, Dose 3 |
4
16%
|
5
19.2%
|
2
7.7%
|
1
4%
|
2
7.7%
|
| Neck Swelling, Dose 1 |
2
8%
|
3
11.5%
|
2
7.7%
|
0
0%
|
3
11.5%
|
| Neck Swelling, Dose 2 |
2
8%
|
1
3.8%
|
1
3.8%
|
2
8%
|
3
11.5%
|
| Neck Swelling, Dose 3 |
1
4%
|
2
7.7%
|
3
11.5%
|
2
8%
|
1
3.8%
|
| Armpit Swelling, Dose 1 |
1
4%
|
1
3.8%
|
1
3.8%
|
0
0%
|
2
7.7%
|
| Armpit Swelling, Dose 2 |
1
4%
|
0
0%
|
0
0%
|
2
8%
|
1
3.8%
|
| Armpit Swelling, Dose 3 |
0
0%
|
0
0%
|
0
0%
|
1
4%
|
1
3.8%
|
| Title | Number of Participants With Any Adverse Event |
|---|---|
| Description | |
| Time Frame | Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Post-Dose 1 |
12
48%
|
11
42.3%
|
10
38.5%
|
10
40%
|
15
57.7%
|
| Post-Dose 2 |
8
32%
|
11
42.3%
|
10
38.5%
|
8
32%
|
8
30.8%
|
| Post-Dose 3 |
7
28%
|
13
50%
|
8
30.8%
|
8
32%
|
7
26.9%
|
| Through Day 336 or Early Withdrawal |
18
72%
|
22
84.6%
|
19
73.1%
|
19
76%
|
22
84.6%
|
| Title | Number of Participants With Any Serious Adverse Event |
|---|---|
| Description | |
| Time Frame | Through Day 336 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Count of Participants [Participants] |
0
0%
|
2
7.7%
|
0
0%
|
2
8%
|
0
0%
|
| Title | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality |
|---|---|
| Description | Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein. |
| Time Frame | Through Day 336 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Day 28 |
14
56%
|
10
38.5%
|
15
57.7%
|
8
32%
|
11
42.3%
|
| Day 56 |
13
52%
|
13
50%
|
15
57.7%
|
14
56%
|
11
42.3%
|
| Day 84 |
13
52%
|
11
42.3%
|
13
50%
|
13
52%
|
14
53.8%
|
| Day 168 |
16
64%
|
11
42.3%
|
14
53.8%
|
13
52%
|
14
53.8%
|
| Day 196 |
12
48%
|
13
50%
|
15
57.7%
|
13
52%
|
11
42.3%
|
| Day 280 |
14
56%
|
13
50%
|
13
50%
|
13
52%
|
16
61.5%
|
| Day 336 |
14
56%
|
14
53.8%
|
16
61.5%
|
13
52%
|
14
53.8%
|
| Title | Geometric Mean Titer of Antibody Binding to CMV gB |
|---|---|
| Description | |
| Time Frame | Through Day 336 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated). |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Day 0 |
1126.00
(NA)
|
NA
(NA)
|
NA
(NA)
|
1077.29
(1.85)
|
505.00
(NA)
|
| Day 28 |
NA
(NA)
|
863.00
(NA)
|
NA
(NA)
|
1493.80
(2.05)
|
580.3
(1.15)
|
| Day 56 |
1461.82
(1.15)
|
933.07
(1.16)
|
691.90
(1.21)
|
1468.22
(1.93)
|
1072.06
(1.41)
|
| Day 84 |
7410.59
(2.59)
|
10378.98
(2.87)
|
15212.90
(2.54)
|
3097.78
(3.24)
|
1306.99
(1.01)
|
| Day 168 |
2578.32
(2.04)
|
3554.05
(2.48)
|
5344.20
(3.38)
|
1901.01
(2.00)
|
1241.41
(3.21)
|
| Day 196 |
24832.80
(3.56)
|
32600.15
(3.27)
|
48189.54
(2.73)
|
12579.63
(5.79)
|
2086.94
(1.91)
|
| Day 280 |
8736.27
(4.24)
|
13564.41
(3.06)
|
25574.36
(3.65)
|
5877.74
(5.45)
|
3115.63
(1.35)
|
| Day 336 |
4977.61
(3.09)
|
9543.19
(3.58)
|
12351.83
(3.79)
|
3719.56
(3.80)
|
2907.15
(5.73)
|
| Title | Geometric Mean Titer of Antibody Avidity Index Value Against gB |
|---|---|
| Description | To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea. |
| Time Frame | Through Day 336 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Day 28 |
38.98
(1.79)
|
41.83
(1.47)
|
33.81
(1.52)
|
35.53
(2.72)
|
38.67
(1.85)
|
| Day 84 |
64.56
(1.20)
|
64.77
(1.22)
|
71.91
(1.15)
|
57.73
(1.55)
|
47.55
(2.10)
|
| Day 196 |
77.17
(1.14)
|
79.58
(1.13)
|
83.43
(1.07)
|
69.71
(1.29)
|
36.39
(2.84)
|
| Day 336 |
74.82
(1.18)
|
75.86
(1.13)
|
80.81
(1.09)
|
66.43
(1.39)
|
44.20
(2.09)
|
| Title | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells |
|---|---|
| Description | |
| Time Frame | Through Day 196 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. Samples with antibody titers below the assay cut point were not included in the calculation of geometric mean or standard deviation. |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Day 84 |
77.48
(1.98)
|
88.80
(2.19)
|
140.38
(2.35)
|
107.06
(2.41)
|
NA
(NA)
|
| Day 196 |
139.40
(2.67)
|
165.25
(2.29)
|
254.31
(2.73)
|
101.10
(3.35)
|
NA
(NA)
|
| Title | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells |
|---|---|
| Description | |
| Time Frame | Through Day 336 or early withdrawal |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated). |
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
| Measure Participants | 25 | 25 | 25 | 23 | 26 |
| Day 28 |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
| Day 84 |
NA
(NA)
|
NA
(NA)
|
221.28
(1.57)
|
NA
(NA)
|
NA
(NA)
|
| Day 168 |
151.00
(NA)
|
NA
(NA)
|
NA
(NA)
|
177.00
(NA)
|
NA
(NA)
|
| Day 196 |
159.69
(1.11)
|
281.00
(NA)
|
287.24
(1.45)
|
261.95
(1.17)
|
NA
(NA)
|
| Day 280 |
NA
(NA)
|
152.00
(NA)
|
288.17
(1.69)
|
NA
(NA)
|
NA
(NA)
|
| Day 336 |
151.00
(NA)
|
NA
(NA)
|
234.80
(1.82)
|
NA
(NA)
|
NA
(NA)
|
Adverse Events
| Time Frame | Adverse events were collected from the first injection on Day 0 to Day 336 or early withdrawal, six months post Dose 3 in all participants, in all groups. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | |||||
| Arm/Group Description | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 0.5 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 2.0 μg VBI-1501A human CMV glycoprotein B (gB) adsorbed on Adju-Phos® adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of 1.0 μg VBI-1501 human CMV without adjuvant administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | Healthy CMV-seronegative subjects between 18 and 40 years of age received three doses of buffer/sucrose used for VBI-1501 suspension administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 | |||||
All Cause Mortality |
||||||||||
| VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/26 (0%) | 0/26 (0%) | 0/25 (0%) | 0/26 (0%) | |||||
Serious Adverse Events |
||||||||||
| VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 2/25 (8%) | 0/26 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatitis | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Infections and infestations | ||||||||||
| Meningitis Aseptic | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Laceration | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| Psychiatric disorders | ||||||||||
| Depression | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| Vascular disorders | ||||||||||
| Deep Vein Thrombosis | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| VBI-1501A: 0.5µg With Adjuvant | VBI-1501A: 1.0µg With Adjuvant | VBI-1501A: 2.0 µg With Adjuvant | VBI-1501: 1.0µg Without Adjuvant | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/25 (72%) | 23/26 (88.5%) | 20/26 (76.9%) | 21/25 (84%) | 22/26 (84.6%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Lymphadenopathy | 1/25 (4%) | 1 | 1/26 (3.8%) | 1 | 1/26 (3.8%) | 1 | 1/25 (4%) | 1 | 2/26 (7.7%) | 2 |
| Gastrointestinal disorders | ||||||||||
| Dyspepsia | 0/25 (0%) | 0 | 2/26 (7.7%) | 4 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Food poisoning | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 |
| Gastrooesophageal Reflux | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 | 2/26 (7.7%) | 3 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Haematochezia | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Nausea | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 | 2/26 (7.7%) | 2 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Vomiting | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 | 2/26 (7.7%) | 2 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| General disorders | ||||||||||
| Chills | 2/25 (8%) | 2 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Fatigue | 3/25 (12%) | 3 | 2/26 (7.7%) | 2 | 4/26 (15.4%) | 4 | 3/25 (12%) | 3 | 1/26 (3.8%) | 2 |
| Influenza Like Illness | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 | 1/26 (3.8%) | 1 | 2/25 (8%) | 2 | 1/26 (3.8%) | 1 |
| Malaise | 4/25 (16%) | 4 | 2/26 (7.7%) | 3 | 2/26 (7.7%) | 2 | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 |
| Infections and infestations | ||||||||||
| Gastroenteritis | 1/25 (4%) | 1 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 3/25 (12%) | 3 | 0/26 (0%) | 0 |
| Herpes Simplex | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/26 (0%) | 0 |
| Nasopharyngitis | 11/25 (44%) | 15 | 5/26 (19.2%) | 9 | 9/26 (34.6%) | 14 | 6/25 (24%) | 8 | 8/26 (30.8%) | 10 |
| Pharyngitis | 2/25 (8%) | 2 | 2/26 (7.7%) | 2 | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Sinusitis | 3/25 (12%) | 3 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| Upper Respiratory Tract Infection | 4/25 (16%) | 4 | 7/26 (26.9%) | 10 | 2/26 (7.7%) | 2 | 3/25 (12%) | 4 | 3/26 (11.5%) | 5 |
| Urinary Tract Infection | 1/25 (4%) | 1 | 4/26 (15.4%) | 4 | 0/26 (0%) | 0 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Arthropod Bite | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/26 (0%) | 0 |
| Laceration | 1/25 (4%) | 1 | 0/26 (0%) | 0 | 2/26 (7.7%) | 2 | 1/25 (4%) | 1 | 0/26 (0%) | 0 |
| Investigations | ||||||||||
| Alanine Aminotransferase Increased | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 3/25 (12%) | 3 | 0/26 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back Pain | 2/25 (8%) | 4 | 1/26 (3.8%) | 1 | 2/26 (7.7%) | 2 | 0/25 (0%) | 0 | 1/26 (3.8%) | 1 |
| Nervous system disorders | ||||||||||
| Headache | 6/25 (24%) | 9 | 8/26 (30.8%) | 12 | 5/26 (19.2%) | 8 | 6/25 (24%) | 6 | 5/26 (19.2%) | 10 |
| Psychiatric disorders | ||||||||||
| Anxiety | 0/25 (0%) | 0 | 2/26 (7.7%) | 2 | 2/26 (7.7%) | 2 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Asthma | 0/25 (0%) | 0 | 0/26 (0%) | 0 | 0/26 (0%) | 0 | 2/25 (8%) | 2 | 0/26 (0%) | 0 |
| Nasal Congestion | 1/25 (4%) | 2 | 2/26 (7.7%) | 4 | 2/26 (7.7%) | 2 | 0/25 (0%) | 0 | 0/26 (0%) | 0 |
| Orophyngeal Pain | 4/25 (16%) | 5 | 1/26 (3.8%) | 1 | 0/26 (0%) | 0 | 2/25 (8%) | 3 | 1/26 (3.8%) | 1 |
Limitations/Caveats
[Not Specified]
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 | Bebi Yassin-Rajkumar |
|---|---|
| Organization | VBI |
| Phone | 613-749-4200 ext 151 |
| byassin-rajkumar@vbivaccines.com |
Responsible Party:
VBI Vaccines Inc.
ClinicalTrials.gov Identifier:
NCT02826798
Other Study ID Numbers:
- VBI-1501
First Posted:
Jul 11, 2016
Last Update Posted:
Apr 20, 2020
Last Verified:
Apr 1, 2020