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Cytomegalovirus InfectionsPhase 1NCT02826798

Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults

A Phase 1 study testing VBI-1501A 0.5 μg, VBI-1501A 1.0 μg and VBI-1501A 2.0 μg in people with Cytomegalovirus Infections, run by VBI Vaccines Inc. at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cytomegalovirus Infections
What is being tested?
VBI-1501A 0.5 μg, VBI-1501A 1.0 μg and VBI-1501A 2.0 μg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
3 sitesCanada
Study dates
23 Jun 2016to 24 Aug 2017
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Canadian Center for Vaccinology; IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McGill University Health Centre - Vaccine Study

    Pierrefonds, Quebec, H9H 4Y6

  • Vaccine Evaluation Center

    Vancouver, British Columbia, V5Z 4H4

Other trials in Canada

About this study

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

The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

Read the 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.

Being tested
VBI-1501A 0.5 μg, VBI-1501A 1.0 μg, VBI-1501A 2.0 μg, VBI-1501 1.0 μg, Placebo
Keywords
VBI-1501A, VBI-1501, prophylactic vaccine, virus diseases, cytomegalovirus (CMV), cytomegalovirus infections, cytomegalovirus vaccines, Herpesviridae Infections, Phase 1, Human Herpesvirus 5 (HHV5), Vaccines, virus-like particle (VLP), enveloped virus-like particle (eVLP)
Medical subject headings
Cytomegalovirus Infections, Virus Diseases, Herpesviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VBI-1501A 0.5 μgDrug

    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 μgDrug

    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 μgDrug

    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 μgDrug

    VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

  • PlaceboDrug

    buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

Study groups in NCT02826798
Study groupRoleWhat they receive
VBI-1501A: 0.5µg with adjuvantExperimental0.5µg CMV vaccine with adjuvant
Receives: Drug: VBI-1501A 0.5 μg
VBI-1501A: 1.0µg with adjuvantExperimental1.0µg CMV vaccine with adjuvant
Receives: Drug: VBI-1501A 1.0 μg
VBI-1501A: 2.0 µg with adjuvantExperimental2.0 µg CMV vaccine with adjuvant
Receives: Drug: VBI-1501A 2.0 μg
VBI-1501: 1.0µg without adjuvantExperimental1.0µg CMV vaccine without adjuvant
Receives: Drug: VBI-1501 1.0 μg
PlaceboPlacebo comparatorBuffer/sucrose used for VBI-1501 suspension
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period

    Measured: Day of vaccine administration (days 0, 56, 168) and six subsequent days

  2. Number of Participants With Any Adverse Event

    Measured: 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.

  3. Number of Participants With Any Serious Adverse Event

    Measured: Through Day 336 or early withdrawal

  4. 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.

    Measured: Through Day 336 or early withdrawal

Secondary outcomes (4)

  1. Geometric Mean Titer of Antibody Binding to CMV gB

    Measured: Through Day 336 or early withdrawal

  2. 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.

    Measured: Through Day 336 or early withdrawal

  3. Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells

    Measured: Through Day 196 or early withdrawal

  4. Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells

    Measured: Through Day 336 or early withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study start23 Jun 2016
  3. Primary completion15 Sep 2016
  4. Study completion24 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826798
Sponsor's protocol ID
VBI-1501
Status last verified
Apr 2020
First submitted
23 Jun 2016
Last updated
20 Apr 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 7798679

  • 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.

    PubMed 18096431

  • 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.

    PubMed 18063447

  • 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.

    PubMed 12184360

  • 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.

    PubMed 23845948

  • 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. doi: 10.1111/j.1399-0012.2006.00618.x.

    PubMed 17425738

  • 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.

    PubMed 23107592

  • 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.

    PubMed 18813779

  • 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.

    PubMed 21481708

  • 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.

    PubMed 25295500

  • 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/

    PubMed 25121214

  • 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.

    PubMed 23246547

  • 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.

    PubMed 19889756

  • 15. Paneque-Quevedo AA. Inorganic compounds as vaccine adjuvants. Biotecnología Aplicada. 2013;30:250-256.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VBI-1501A 0.5 μg, VBI-1501A 1.0 μg and VBI-1501A 2.0 μg in people with Cytomegalovirus Infections, run by VBI Vaccines Inc. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period (time frame: Day of vaccine administration (days 0, 56, 168) and six subsequent days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02826798, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.

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