VBI Vaccines Announces Positive Interim Data from Phase 1 Study of Preventative CMV Vaccine
- Category: Vaccines
- Published on Saturday, 29 July 2017 09:17
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- Well tolerated at all doses with no safety signals
- 100% seroconversion at highest dose after two of the three planned vaccinations
- Dose-dependent antibody responses against CMV gB antigen
- Full data after third dose expected first half of 2018
July 27, 2017 I VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced positive results from a planned, interim data read-out from a Phase 1 study of its preventative cytomegalovirus (CMV) vaccine.
This interim data read-out analyzed safety data through day 84 of the study and initial immunogenicity signals in participant samples collected one month after the second of three planned vaccine doses.
- The vaccine was well tolerated at all doses, with no safety signals.
- The vaccine induced antibody responses against the CMV glycoprotein B (gB) antigen with clear evidence of dose-dependent boosting after the second vaccination.
- Immunization with the highest dose of the vaccine induced seroconversion in 100% of subjects after just two vaccinations.
- After two of the three planned vaccinations, neutralizing antibodies against epithelial cell infection were demonstrated in 17% of subjects who received the highest dose of VBI-1501A.
- The highest dose of VBI-1501A (2.0μg of gB-G content with alum) has approximately 10-fold less antigen content than that used in several other VLP-based vaccines or in past CMV vaccine candidates.
- Formulation of the vaccine with alum enhanced antibody titers.
“This pre-planned interim read-out has provided us with an excellent early look at the safety and immunogenicity of our CMV vaccine candidate,” said Jeff Baxter, President and CEO of VBI. “The safety and tolerability data is critical, as this is the first-in-humans clinical study with a candidate generated from our enveloped virus-like particle (eVLP) technology. Moreover, we saw 100% seroconversion in subjects who received the highest dose of VBI-1501A, a dose-dependent boosting response, and development of neutralizing antibodies in some patients after two doses, providing us with confidence at this point that our vaccine is working as we intended. We look forward to seeing the final three-dose data in the first half of 2018.”
Joanne Langley, M.D., professor of pediatrics in the Division of Infectious Disease at Dalhousie University and principal investigator of the study, commented, “we are encouraged by this interim data, which provide early evidence that VBI’s eVLP CMV candidate has the potential to safely and effectively induce seroconversion and elicit neutralizing antibody titers.”
David Anderson, Ph.D., VBI Chief Scientific Officer, further commented, “induction of neutralizing antibodies that prevent epithelial cell infection has been a challenge for past CMV vaccines. The fact that we observe neutralizing activity against epithelial cell infection after just two doses is promising.”
About the Phase I Clinical Study
This study is a Phase I randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of VBI’s preventative CMV vaccine in healthy adults. The study enrolled 128 CMV-negative subjects, aged 18-40 years, who were randomized into five arms to receive various dose levels of a modified form of gB, gB-G, with or without the adjuvant alum, or placebo:
- .5μg of gB-G content with alum (VBI-1501A 0.5μg)
- 1.0μg of gB-G content with alum (VBI-1501A 1.0μg)
- 1.0μg of gB-G content without alum (VBI-1501 1.0μg)
- 2.0μg of gB-G content with alum (VBI-1501A 2.0μg)
Patients were vaccinated at zero, two, and six months. VBI reported that all patients had received the third and final vaccination in May 2017. Final safety data through day 336 of the study and final immunogenicity data based on subject samples collected after the third vaccination is expected in the first half of 2018.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798.
CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and developmental delays. CMV affects more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.
SOURCE: VBI Vaccines