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VBIV

VBI Vaccines

$1.37 /

-0.02 (-1.44%)

, GSK

GlaxoSmithKline

$46.41 /

+0.18 (+0.39%)

08:16
01/09/20
01/09
08:16
01/09/20
08:16

VBI Vaccines Phase 3 CONSTANT study meets primary, secondary endpoints

VBI Vaccines (VBIV) reported top-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac, the company's trivalent hepatitis B, or HBV, vaccine and comparing safety and immunogenicity of Sci-B-Vac to GlaxoSmithKline's (GSK) currently-marketed HBV vaccine, Engerix-B. The Phase 3 study, which enrolled 2,838 adults, age 18-45 years, met both the primary and secondary endpoints. The primary endpoint of the study was lot-to-lot consistency for immune response, as measured by geometric mean concentration, or GMC, of antibodies across three independent, consecutively-manufactured lots of Sci-B-Vac, four weeks after the third vaccination. Together with the safety and immunogenicity results of the PROTECT Phase 3 study, these data comprise the basis for the regulatory submissions in the U.S., Europe, and Canada, expected to begin in the second half of 2020. A secondary endpoint of the study was non-inferior immunogenicity as measured by seroprotection rates, or SPR, at day 196, one month after completion of the full course of vaccination with either Sci-B-Vac or Engerix-B. At day 196, the pooled SPR in subjects who received Sci-B-Vac was 99.3% compared to 94.8% for those who received Engerix-B - a difference of 4.49%; 95% Ccnfidence interval, or CI, up from 90.4% for Sci-B-Vac and 51.6% for Engerix-B at day 168, after only two vaccinations. In addition to demonstrating non-inferiority, the SPR achieved with Sci-B-Vac compared with Engerix-B was higher after both two and three vaccinations. The safety and tolerability seen in CONSTANT were consistent with the known safety profile of Sci-B-Vac. No new safety risks were identified and no safety signals were observed in either cohort. The integrated safety data analysis from both the PROTECT and CONSTANT studies is underway. An exploratory analysis in CONSTANT also compared the SPR after two doses of Sci-B-Vac to the SPR after three doses of Engerix-B. At these times points, the SPR was 90.4% for Sci-B-Vac and 94.8% for Engerix-B, a difference of -4.3%; 95% CI. As per the commonly-used statistical margin of non-inferiority for vaccines, defined as the lower limit of the 95% CI being above -10%, this analysis demonstrated non-inferiority after two doses of Sci-B-Vac compared with three doses of Engerix-B. Similarly, at these time points, preliminary data from the integrated immunogenicity analysis of both the PROTECT and CONSTANT studies in subjects age 18-45 years demonstrate a difference in SPR of -4.2%; 95% CI. The two vs. three dose comparison is not part of the regulatory approval process and would not be included in the expected indication the company will seek, but does contribute to the robust immunogenicity profile of Sci-B-Vac.

VBIV

VBI Vaccines

$1.37 /

-0.02 (-1.44%)

GSK

GlaxoSmithKline

$46.41 /

+0.18 (+0.39%)

  • 27

    Jan

VBIV VBI Vaccines
$1.37 /

-0.02 (-1.44%)

11/14/19 Raymond James
VBI Vaccines initiated with an Outperform at Raymond James
06/18/19 BMO Capital
VBI Vaccines price target lowered to $5 from $12 at BMO Capital
01/16/19 Oppenheimer
VBI Vaccines initiated with an Outperform at Oppenheimer
01/16/19 Oppenheimer
VBI Vaccines initiated with an Outperform at Oppenheimer
GSK GlaxoSmithKline
$46.41 /

+0.18 (+0.39%)

12/16/19 Goldman Sachs
BioMarin, Regeneron among Goldman's six Healthcare 'laggards' for 2020
12/03/19 Morgan Stanley
Morgan Stanley sees high odds of Bluebird trading up after multiple myeloma data
12/02/19 SVB Leerink
GlaxoSmithKline initiated with an Outperform at SVB Leerink
11/21/19
Fly Intel: Top five analyst upgrades

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