Drugs / VBI-1501A
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02826798 | Jun → Sep 2016 | cytomegalovirus infection | VBI Vaccines Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2018-05-10 | VBI Vaccines Inc. | Results VBI Vaccines Announces Positive Final Phase 1 Study Results of Preventative CMV Vaccine vbivaccines.com ↗
The highest dose of VBI-1501, 2.0μg, elicited protective CMV-neutralizing antibodies against fibroblast cell infection in 100% of subjects after the third vaccination, inducing titers comparable to those observed in patients protected as a result of natural infection. |
| 2017-07-27 | VBI Vaccines Inc. | Results VBI Vaccines Announces Positive Interim Data from Phase 1 Study of Preventative CMV Vaccine vbivaccines.com ↗
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. |
| 2015-04-09 | VBI Vaccines Inc. | Results VBI Announces New Data Supporting the Manufacture of its Prophylactic CMV Vaccine Candidate vbivaccines.com ↗
A separate in vivo potency assay assessed the consistency and potency of multiple batches of VBI-1501A, with positive interim results. |
| 2014-09-15 | VBI Vaccines Inc. | Results New Data Supporting VBI’s Prophylactic CMV Vaccine Candidate Presented at the ICAAC Conference vbivaccines.com ↗
VBI’s preclinical animal data demonstrates that VBI-1501A has substantially improved potency and durability, at levels now exceeding a benchmark for naturally acquired immunity. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-05-10 | VBI Vaccines Inc. | VBI Vaccines Announces Positive Final Phase 1 Study Results of Preventative CMV Vaccine vbivaccines.com ↗ |
| 2017-07-27 | VBI Vaccines Inc. | VBI Vaccines Announces Positive Interim Data from Phase 1 Study of Preventative CMV Vaccine vbivaccines.com ↗ |
| 2015-04-09 | VBI Vaccines Inc. | VBI Announces New Data Supporting the Manufacture of its Prophylactic CMV Vaccine Candidate vbivaccines.com ↗ |
| 2014-09-15 | VBI Vaccines Inc. | New Data Supporting VBI’s Prophylactic CMV Vaccine Candidate Presented at the ICAAC Conference vbivaccines.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VBI-1501A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02826798 ↗ |
| Modality | Vaccine | “an enveloped virus-like particle (eVLP) vaccine expressing a modified form of the CMV glycoprotein B (gB)” PMID 38142214 ↗ Dec 2023 |
| Route | Intramuscular | “VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168” NCT02826798 ↗ |