Valneva Announces Positive Homologous Booster Data for Inactivated,
Adjuvanted COVID-19 Vaccine Candidate VLA2001
- Initial
results show excellent immune response after third dose of VLA2001
administered 7 to 8 months after the second dose of primary
vaccination
- Antibody
titers increased 42- to 106-fold two weeks after booster dose vs
pre-booster levels
- Antibody
titers four-fold higher compared to two weeks after primary
immunization
-
Evaluating sera from boosted participants for cross-neutralization
against Variants Of Concern, including Omicron
Saint Herblain
(France),
December 16,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today announced positive
homologous booster data from the Phase 1/2 study, of its
inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
Initial results confirm that VLA2001 significantly boosted immunity
in participants who received VLA2001 as a primary vaccination.
77 of the 153 original Phase 1/2 study
participants, aged 18-55 years, received a booster dose seven to
eight months after completion of their primary immunization with
either a low, medium or high dose of VLA2001. All participants
received a single booster vaccination with VLA2001 at the same
(high) dose level used in the pivotal Phase 3 “Cov-Compare” trial.1
IgG antibody titers (spike protein-based) were measured at the time
of the booster as well as two weeks after the booster dose. 45 of
the 77 boosted participants were included in the final
analysis.2
A third dose of VLA2001 elicited an excellent
anamnestic response, with similar antibody levels observed whether
participants were initially vaccinated with a low, medium or high
dose (GMT 9699.3 (95%CI: 8497.76, 11070.71)). This represents a
strong boosting effect, increasing levels of antibodies against the
Wuhan virus 42- to 106-fold, depending on the pre-boosting levels
of antibodies.
Antibody levels measured two weeks after the
booster dose were approximately four-fold higher compared to those
observed two weeks after primary immunization.
Juan Carlos Jaramillo,
M.D., Chief Medical Officer of
Valneva, commented: “We are extremely pleased to report
our first booster data, confirming that VLA2001 significantly
boosted immunity in participants who received VLA2001 as a primary
vaccination and regardless of the initial neutralizing antibody
level at the time of boosting. Boostering several months, typically
six months or more, after primary immunisation is generally
effective for inactivated, adjuvanted vaccines. Our teams are
working diligently on our rolling review regulatory submissions so
that we can quickly deploy our vaccine and ensure it reaches the
people who need it. I would like to thank again the trial
investigators, participants and collaborators, especially the
National Institute for Health Research and the clinical teams
within the NHS Research Centres.”
In addition to these initial booster data,
Valneva expects to report further homologous booster data from the
Phase 3 Cov-Compare study. In parallel, the Company is preparing to
launch a dedicated heterologous booster trial, which will evaluate
a VLA2001 booster shot provided at least six months after primary
vaccination with other vaccines or following natural infection.
This study is expected to commence in early 2022.
Valneva will also evaluate the sera from the
boosted participants for cross-neutralization against Variants of
Concern, including Omicron.
About Phase 1/2
Trial
VLA2001-201
VLA2001-201 is a randomized, dose-finding trial to evaluate the
safety, tolerability and immunogenicity of the inactivated,
adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001 in healthy
subjects. VLA2001-201 is the first-in-human Phase 1/2 trial
evaluating three dose levels of VLA2001 (low, medium, high) for
safety, tolerability and immunogenicity in a two-dose schedule with
intra muscular vaccinations three weeks apart. Overall, 153 healthy
young adults aged 18 to 55 years were recruited in the trial.
VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day
36) and Part B (Day 37 to Day 208).
77 subjects from the 153 study participants
originally included in the Phase 1/2 trial received a booster dose
approximately 7-8 months after completion of their primary
vaccination series.
About VLA2001VLA2001 is currently the only
whole virus, inactivated, adjuvanted vaccine candidate against
COVID-19 in clinical trials in Europe. It is intended for active
immunization of at-risk populations to prevent carriage and
symptomatic infection with COVID-19 during the ongoing pandemic and
potentially later for routine vaccination including addressing new
variants. VLA2001 may also be suited for boosting, as repeat
booster vaccinations have been shown to work well with whole virus
inactivated vaccines. VLA2001 is produced on Valneva’s established
Vero-cell platform, leveraging the manufacturing technology for
Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001
consists of inactivated whole virus particles of SARS-CoV-2 with
high S-protein density, in combination with two adjuvants, alum and
CpG 1018. This adjuvant combination has consistently induced higher
antibody levels in preclinical experiments than alum-only
formulations and shown a shift of the immune response towards Th1.
CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation
(Nasdaq: DVAX), is a component of the US FDA- and EMA-approved
HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which
has already been upscaled to final industrial scale, includes
chemical inactivation to preserve the native structure of the
S-protein. VLA2001 is expected to conform with standard cold chain
requirements (2 degrees to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused
on the development and commercialization of prophylactic vaccines
for infectious diseases with significant unmet medical need. The
Company takes a highly specialized and targeted approach to vaccine
development and then applies its deep understanding of vaccine
science to develop prophylactic vaccines addressing these diseases.
Valneva has leveraged its expertise and capabilities both to
successfully commercialize two vaccines and to rapidly advance a
broad range of vaccine candidates into and through the clinic,
including candidates against Lyme disease, the chikungunya virus
and COVID-19.
Media
& Investors ContactsLaëtitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
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1 Valneva Reports Positive Phase 3 Results for Inactivated,
Adjuvanted COVID-19 Vaccine Candidate VLA20012 27 of the remaining
participants who were not included in the final analysis had also
received another COVID-19 vaccine, and five experienced a COVID-19
infection during the study.
- 2021_12_16_VLA2001_Phase2_Booster_Results_PR_EN_Final
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