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| Name | Class |
|---|---|
| Clinical Trial Data Services, LLC | UNKNOWN |
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The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBI-1501A: 0.5µg with adjuvant | Experimental | 0.5µg CMV vaccine with adjuvant |
|
| VBI-1501A: 1.0µg with adjuvant | Experimental | 1.0µg CMV vaccine with adjuvant |
|
| VBI-1501A: 2.0 µg with adjuvant | Experimental | 2.0 µg CMV vaccine with adjuvant |
|
| VBI-1501: 1.0µg without adjuvant | Experimental | 1.0µg CMV vaccine without adjuvant |
|
| Placebo | Placebo Comparator | Buffer/sucrose used for VBI-1501 suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBI-1501A 0.5 μg | Drug | VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Through Day 336 or early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Langley, MD | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Evaluation Center | Vancouver | British Columbia | V5Z 4H4 | Canada | ||
| Canadian Center for Vaccinology; IWK Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7798679 | Background | 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. doi: 10.1093/infdis/171.1.26. | |
| 18096431 | Background | Adler SP. Human CMV vaccine trials: what if CMV caused a rash? J Clin Virol. 2008 Mar;41(3):231-6. doi: 10.1016/j.jcv.2007.11.008. Epub 2007 Dec 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VBI-1501A: 0.5µg With Adjuvant | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| VBI-1501A 1.0 μg | Drug | VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
|
| VBI-1501A 2.0 μg | Drug | VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
|
| VBI-1501 1.0 μg | Drug | VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 |
|
| Placebo | Drug | buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168. |
|
| Through Day 336 or early withdrawal |
| 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 |
| Halifax |
| Nova Scotia |
| B3K 6R8 |
| Canada |
| McGill University Health Centre - Vaccine Study | Pierrefonds | Quebec | H9H 4Y6 | Canada |
| 18063447 | Background | 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. doi: 10.1016/j.vaccine.2007.10.048. Epub 2007 Nov 9. |
| 12184360 | Background | Baylor NW, Egan W, Richman P. Aluminum salts in vaccines--US perspective. Vaccine. 2002 May 31;20 Suppl 3:S18-23. doi: 10.1016/s0264-410x(02)00166-4. |
| 23845948 | Background | 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. |
| Background | 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. |
| 17425738 | Background | 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. doi: 10.1111/j.1399-0012.2006.00618.x. |
| 23107592 | Background | 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. |
| 18813779 | Background | 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. |
| 21481708 | Background | 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. |
| 25295500 | Background | 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, Fernandez 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 gamma-retrovirus vector for X-linked severe combined immunodeficiency. N Engl J Med. 2014 Oct 9;371(15):1407-17. doi: 10.1056/NEJMoa1404588. |
| 25121214 | Background | 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK233313/ |
| 23246547 | Background | 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. |
| 19889756 | Background | 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. |
| Background | 15. Paneque-Quevedo AA. Inorganic compounds as vaccine adjuvants. Biotecnología Aplicada. 2013;30:250-256. |
| 10479120 | Background | Pass RF, Duliege 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. doi: 10.1086/315022. |
| 19297572 | Background | 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. |
| 12361753 | Background | Plotkin SA. Is there a formula for an effective CMV vaccine? J Clin Virol. 2002 Aug;25 Suppl 2:S13-21. doi: 10.1016/s1386-6532(02)00093-8. No abstract available. |
| 24651029 | Background | 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. |
| 38142214 | Derived | Langley JM, Gantt S, Halperin SA, Ward B, McNeil S, Ye L, Cai Y, Smith B, Anderson DE, Mitoma FD. An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study. Vaccine. 2024 Jan 25;42(3):713-722. doi: 10.1016/j.vaccine.2023.12.019. Epub 2023 Dec 22. |
| VBI-1501A: 1.0µg With Adjuvant |
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 |
| FG002 | VBI-1501A: 2.0 µg With Adjuvant | 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 |
| FG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| FG004 | Placebo | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VBI-1501A: 0.5µg With Adjuvant | 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 |
| BG001 | VBI-1501A: 1.0µg With Adjuvant | 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 |
| BG002 | VBI-1501A: 2.0 µg With Adjuvant | 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 |
| BG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| BG004 | Placebo | 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 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period | Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. | Posted | Count of Participants | Participants | Day of vaccine administration (days 0, 56, 168) and six subsequent days |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Adverse Event | Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. | Posted | Count of Participants | Participants | 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. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Serious Adverse Event | Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. | Posted | Count of Participants | Participants | Through Day 336 or early withdrawal |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Hematological or Biochemical Laboratory Abnormality | 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. | Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. | Posted | Count of Participants | Participants | Through Day 336 or early withdrawal |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer of Antibody Binding to CMV gB | 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). | Posted | Geometric Mean | Standard Deviation | Titer | Through Day 336 or early withdrawal |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer of Antibody Avidity Index Value Against gB | 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. | Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. | Posted | Geometric Mean | Standard Deviation | Avidity index | Through Day 336 or early withdrawal |
| ||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells | 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. | Posted | Geometric Mean | Standard Deviation | Titer | Through Day 196 or early withdrawal |
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells | 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). | Posted | Geometric Mean | Standard Deviation | Titer | Through Day 336 or early withdrawal |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VBI-1501A: 0.5µg With Adjuvant | 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 | 0 | 25 | 0 | 25 | 18 | 25 |
| EG001 | VBI-1501A: 1.0µg With Adjuvant | 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 | 0 | 26 | 2 | 26 | 23 | 26 |
| EG002 | VBI-1501A: 2.0 µg With Adjuvant | 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 | 0 | 26 | 1 | 26 | 20 | 26 |
| EG003 | VBI-1501: 1.0µg Without Adjuvant | 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 | 0 | 25 | 2 | 25 | 21 | 25 |
| EG004 | Placebo | 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 | 0 | 26 | 0 | 26 | 22 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis | Hepatobiliary disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Meningitis Aseptic | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA SOC/PT | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA SOC/PT | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Gastrooesophageal Reflux | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Chills | General disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA SOC/PT | Systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA SOC/PT | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA SOC/PT | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA SOC/PT | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA SOC/PT | Systematic Assessment |
| |
| Orophyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA SOC/PT | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bebi Yassin-Rajkumar | VBI | 613-749-4200 | 151 | byassin-rajkumar@vbivaccines.com |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D014777 | Virus Diseases |
| D006566 | Herpesviridae Infections |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D007239 | Infections |
Not provided
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| Male |
|
| White, Caucasian |
|
| Chinese |
|
| Black |
|
| Filipino |
|
| West Asian |
|
| Alaskan Native |
|
| Other |
|
|
| Pain at injection site, Dose 2 |
|
|
| Pain at injection site, Dose 3 |
|
|
| Fatigue, Dose 1 |
|
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| Fatigue, Dose 2 |
|
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| Fatigue, Dose 3 |
|
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| Diarrhea, Dose 1 |
|
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| Diarrhea, Dose 2 |
|
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| Diarrhea, Dose 3 |
|
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| Nausea/Vomiting, Dose 1 |
|
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| Nausea/Vomiting, Dose 2 |
|
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| Nausea/Vomiting, Dose 3 |
|
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| Headache, Dose 1 |
|
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| Headache, Dose 2 |
|
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| Headache, Dose 3 |
|
|
| Malaise, Dose 1 |
|
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| Malaise, Dose 2 |
|
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| Malaise, Dose 3 |
|
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| Myalgia, Dose 1 |
|
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| Myalgia, Dose 2 |
|
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| Myalgia, Dose 3 |
|
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| Neck Swelling, Dose 1 |
|
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| Neck Swelling, Dose 2 |
|
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| Neck Swelling, Dose 3 |
|
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| Armpit Swelling, Dose 1 |
|
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| Armpit Swelling, Dose 2 |
|
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| Armpit Swelling, Dose 3 |
|
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| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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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 |
| OG004 | Placebo | 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 |
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| OG002 |
| VBI-1501A: 2.0 µg With Adjuvant |
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 |
| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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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 |
| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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| OG003 | VBI-1501: 1.0µg Without Adjuvant | 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 |
| OG004 | Placebo | 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 |
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