Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
NCT ID: NCT02826798
Last Updated: 2020-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2016-06-23
2017-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VBI-1501A: 0.5µg with adjuvant
0.5µg CMV vaccine with adjuvant
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
VBI-1501A: 1.0µg with adjuvant
1.0µg CMV vaccine with adjuvant
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
VBI-1501A: 2.0 µg with adjuvant
2.0 µg CMV vaccine with adjuvant
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
VBI-1501: 1.0µg without adjuvant
1.0µg CMV vaccine without adjuvant
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
Buffer/sucrose used for VBI-1501 suspension
Placebo
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Interventions
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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
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
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
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
buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Eligibility Criteria
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Inclusion Criteria
2. Serologically confirmed to be CMV seronegative at screening;
3. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
4. 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
2. 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
3. Previous receipt of any cytomegalovirus vaccine
4. History of allergic reactions or anaphylactic reaction to any vaccine component
5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
7. 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
8. 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
9. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
11. Are family members of study center staff
18 Years
40 Years
ALL
Yes
Sponsors
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Clinical Trial Data Services, LLC
UNKNOWN
VBI Vaccines Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne Langley, MD
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Locations
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Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Canadian Center for Vaccinology; IWK Health Centre
Halifax, Nova Scotia, Canada
McGill University Health Centre - Vaccine Study
Pierrefonds, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
Amai M, Nojima M, Yuki Y, Kiyono H, Nagamura F. A review of criteria strictness in "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". Vaccine. 2023 Aug 31;41(38):5622-5629. doi: 10.1016/j.vaccine.2023.07.072. Epub 2023 Aug 1.
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.
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, 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.
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/
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.
15. Paneque-Quevedo AA. Inorganic compounds as vaccine adjuvants. Biotecnología Aplicada. 2013;30:250-256.
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.
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. doi: 10.1016/s1386-6532(02)00093-8. No abstract available.
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.
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.
Other Identifiers
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VBI-1501
Identifier Type: -
Identifier Source: org_study_id
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