- VLA15-221 Phase 2
study: strong immune response shown one month after a second
booster dose (month 31) in pediatric and adult populations
- Significant
anamnestic antibody response observed across all six serotypes,
consistent with previous results
- Favorable safety
profile of VLA15 observed in all age groups and for all
vaccinations
Saint-Herblain (France) and New York,
NY, September 3, 2024 – Valneva SE (Nasdaq:
VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE)
announced today positive immunogenicity and safety data from their
VLA15-221 Phase 2 study following a second booster vaccination of
their Lyme disease vaccine candidate, VLA15, given one year after
receiving the first booster dose. The immune response and safety
profile of VLA15 one month after receiving the second booster dose
were similar to those reported after receiving the first booster
dose, showing compatibility with the anticipated benefit of a
booster vaccination prior to each Lyme season. There are currently
no approved human vaccines for Lyme disease, and VLA15 is the Lyme
disease vaccine candidate which has advanced the furthest along the
clinical development timeline, with two Phase 3 trials in progress.
The Centers for Disease Control and Prevention (CDC) has estimated
that approximately 476,000 people in the U.S. are diagnosed and
treated for Lyme disease each year and 129,000 cases are reported
annually in Europe.1,2
These latest results from the VLA15-221 Phase 2
study again demonstrated a significant anamnestic antibody response
across all six serotypes covered by the vaccine candidate in
pediatric (5 to 11 years of age) and adolescent (12 to 17 years of
age) participants, as well as in adults (18 to 65 years of age),
measured one month after administration of this second booster dose
(month 31). A high proportion of participants seroconverted after
the second booster dose, yielding seroconversion rates* (SCRs)
above 90% for all outer surface protein A (OspA) serotypes in all
age groups, in-line with SCRs after the first booster. Geometric
Mean Titers at one month post first and second booster (i.e. month
19 vs. month 31) were comparably high.
The participants of this Phase 2 study received
VLA15 or placebo during the primary vaccination phase in two
immunization schedules (month 0-2-6 or month 0-6), followed by a
first booster dose at month 18 and a second booster dose at month
30.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are encouraged by
these data, which support the potential benefit of booster doses
across all examined age groups. As Lyme disease continues to
spread, it represents a significant unmet medical need, affecting
numerous individuals throughout the Northern Hemisphere. Each new
set of positive data brings us one step closer to potentially
bringing this vaccine to both adults and children living in areas
where Lyme disease is endemic.”
The safety and tolerability profile of VLA15
after a second booster dose was comparable to the profile observed
after the first booster. To date, no safety concerns were observed
by an independent Data Monitoring Committee (DMC) in any treatment
or age group.
“Personal preventive behaviors are currently the
only recommended strategies to help protect yourself from Lyme
disease. These data from the VLA15-221 study are an important step
towards a potential vaccine that could help prevent the disease and
ease the burden of acute, severe and sometimes persistent
consequences,” said Annaliesa Anderson, Ph.D., Senior
Vice President and Head Vaccine Research and Development at
Pfizer. “Together with our partner Valneva, we look
forward to progressing our vaccine candidate in the ongoing Phase 3
clinical trials.”
In August 2022, Pfizer and Valneva initiated the
currently ongoing Phase 3 clinical study, Vaccine Against Lyme for
Outdoor Recreationists (VALOR) (NCT05477524), to investigate the
efficacy, safety and immunogenicity of VLA15 in participants five
years of age and older in highly endemic regions in the United
States (U.S.) and Europe.3 The primary vaccination
series for all participants was completed in July
2024.4 A second Phase 3 study (VLA15-1012), aiming
to provide further evidence on the safety profile of VLA15 in the
pediatric population, is also ongoing.
Pfizer aims to submit a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
and Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) in 2026, subject to positive Phase 3
data.
About VLA15
VLA15 is an investigational multivalent protein
subunit vaccine that uses an established mechanism of action for a
Lyme disease vaccine that targets the outer surface protein A
(OspA) of Borrelia burgdorferi, the bacteria that cause Lyme
disease. OspA is a surface protein expressed by the bacteria when
present in a tick. Blocking OspA inhibits the bacterium’s ability
to leave the tick and infect humans. The vaccine candidate covers
the six most prevalent OspA serotypes expressed by
the Borrelia burgdorferi sensu lato species in North
America and Europe.
About Clinical Study
VLA15-221
VLA15-221 is a randomized, observer-blind,
placebo-controlled Phase 2 study. It is the first clinical study
with VLA15 which enrolled a pediatric population (5-17 years old).
560 healthy participants received either VLA15 in two immunization
schedules (month 0-2-6 [N=190] or month 0-6 [N=181]) or placebo
(month 0-2-6 [N=189]). Vaccine recipients received VLA15 at a dose
of 180 µg, which was selected based on data generated in two
previous Phase 2 studies. The main safety and immunogenicity
readout (primary endpoint) was performed one month after completion
of the primary series vaccination schedule. All eligible subjects
received booster doses of VLA15 or placebo at month 18 and 30
(booster phase) and will be followed for an additional year to
monitor antibody persistence. In addition, all eligible subjects
will be asked to receive another booster dose of VLA15 or placebo
at month 42, in order to assess the effect of periodic booster
doses.
VLA15 is tested as an alum-adjuvanted
formulation and administered intramuscularly. The study is being
conducted at U.S. sites located in areas where Lyme disease is
endemic and has enrolled both volunteers with a prior infection
with Borrelia burgdorferi as well
as Borrelia burgdorferi-naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by
Borrelia burgdorferi bacteria transmitted to humans by the bite of
infected Ixodes ticks.5 It is considered the most common
vector-borne illness in the Northern Hemisphere.6,7
Early symptoms of Lyme disease (such as a gradually expanding
erythematous rash called erythema migrans or other nonspecific
symptoms like fatigue, fever, headache, mild stiff neck, muscle and
joint pains) are often overlooked or misinterpreted. Left
untreated, the disease can disseminate and cause more serious
chronic complications affecting the skin, joints (arthritis), heart
(carditis) or nervous system.8,9 The medical need for vaccination
against Lyme disease is steadily increasing as the geographic
footprint of the disease widens.10
About Pfizer:
Breakthroughs That
Change Patients’
LivesAt Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development, and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world’s premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For 175 years, we have worked to make a difference for all who rely
on us. We routinely post information that may be important to
investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on X at
@Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe
information contained in this release is as of September 3, 2024.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking
information about an investigational Lyme disease vaccine
candidate, VLA15, and a collaboration between Pfizer and Valneva
for VLA15, including their potential benefits, results from the
VLA15-221 Phase 2 study, Phase 3 clinical trials and the timing of
potential regulatory submissions, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, including
uncertainties relating to the time needed to accrue cases in the
Phase 3 trial and uncertainties relating to an agreement with
regulatory authorities on any modifications to the clinical trial
plan as needed, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when applications
may be filed in any jurisdictions for VLA15; whether and when any
such applications may be approved by regulatory authorities, which
will depend on myriad factors, including making a determination as
to whether the product’s benefits outweigh its known risks and
determination of the product’s efficacy and, if approved, whether
VLA15 will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of VLA15; uncertainties regarding the ability
to obtain recommendations from vaccine advisory or technical
committees and other public health authorities and uncertainties
regarding the commercial impact of any such recommendations;
whether our collaboration with Valneva will be successful;
uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; and competitive
developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2023 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.We have a strong track record,
having advanced multiple vaccines from early R&D to approvals,
and currently market three proprietary travel vaccines, including
the world’s first and only chikungunya vaccine, as well as certain
third-party vaccines.Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, the most
clinically advanced Shigella vaccine candidate, as well as vaccine
candidates against the Zika virus and other global public health
threats. More information is available at www.valneva.com.
Valneva Forward-Looking
StatementsThis press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to business partnerships, the progress,
timing, results and completion of research, development and
clinical trials for product candidates, to regulatory approval of
product candidates and review of existing products. In addition,
even if the actual results or development of Valneva are consistent
with the forward-looking statements contained in this press
release, those results or developments of Valneva may not be
sustained in the future. In some cases, you can identify
forward-looking statements by words such as “could,” “should,”
“may,” “expects,” “anticipates,” “believes,” “intends,”
“estimates,” “aims,” “targets,” or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
and delays involved in the development and manufacture of vaccines,
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, the impact
of the global and European financing environment, and the ability
to obtain or maintain patent or other proprietary intellectual
property protection. Success in preclinical studies or earlier
clinical trials may not be indicative of results in future clinical
trials. In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made in this press
release will in fact be realized. Valneva is providing this
information as of the date of this press release and disclaims any
intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
Media
Contacts
PfizerMedia
Relations:PfizerMediaRelations@pfizer.com+1 212-733-1226
Investor Relations:IR@pfizer.com+1
212-733-4848
ValnevaLaëtitia
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
+1 917 815 4520joshua.drumm@valneva.com
References
- Burn L, et al. Incidence of Lyme Borreliosis in Europe from
National Surveillance Systems (2005–2020). April 2023. Vector Borne
and Zoonotic Diseases. 23(4): 156–171.
- Centers for Disease Control and Prevention. Lyme Disease.
January 2021. Available at:
https ://www.cdc.gov/lyme/stats/humancases.html. Accessed:
August 2023.
- Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease
Vaccine Candidate VLA15. August 2022. Available at:
https://valneva.com/press-release/pfizer-and-valneva-initiate-phase-3-study-of-lyme-disease-vaccine-candidate-vla15/
Accessed: August 2023.
- Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce
Primary Vaccination Series Completion. July 2024. Available at:
https://valneva.com/press-release/phase-3-valor-lyme-disease-trial-valneva-and-pfizer-announce-primary-vaccination-series-completion/
- Stanek et al. 2012, The Lancet 379:461–473
- Centers for Disease Control and Prevention. Lyme Disease.
January 2021. Available
at : https ://www.cdc.gov/lyme/stats/humancases.html.
Accessed: August 2024.
- Kugeler KJ, et al. Estimating the frequency of Lyme disease
diagnoses—United States, 2010-2018. 2021. Emergency Infectious
Disease. 27(2).
- Centers for Disease Control and Prevention. Lyme disease. Signs
and Symptoms. Available from:
https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed
September 2022.
- Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature
Reviews Disease Primers. 2016;2:16090.
- Centers for Disease Control. Understanding Lyme and Other
Tickborne Diseases. May 2022. Available
from: https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html
Accessed: August 2024.
* Seroconversion was defined as the proportion of subjects that
changed from seronegative at baseline to seropositive or showed a
≥four-fold increase in IgG titers compared to baseline if tested
OspA seropositive at baseline.
- 2024_09_03_VLA15-221_m31_PR_EN_Final
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