Testing in pigs for
the Mexican vaccine Patria® showed that both intranasal and
intramuscular administration; as well as a combination of the two, induces
strong antibody responses, including against variants.
The results of
the animal study in pigs executed in January 2021 were the basis for the Phase
I clinical trial in Mexico City.
results from Phase I will allow moving forward into Phase II clinical trials, which
are about to begin.
Mexico City, November 12th, 2021. The SARS-CoV-2 pandemic has represented a great achievement in vaccine
research and development, with results in record time. However, according to
the Pan-American Health Organization, vaccine availability in low and
middle-income countries is still insufficient and producers cannot satisfy
global demand. To enhance vaccination globally, it is necessary to expand the
options for safe and effective vaccines, especially those that can be produced
locally and at a low cost.
All the available vaccines that are authorized
by global regulatory agencies are administered intramuscularly and none intranasally.
This represents an opportunity to develop second-generation vaccines that
potentially induce mucosal immunity, which is the first line of defense in the
upper respiratory tract, often neutralizing incoming viruses and potentially
preventing an infection.
Patria® (AVX/COVID-12) is a vaccine
against COVID-19 based on a live Newcastle disease virus vector expressing a
SARS-CoV-2 spike protein stabilized in a prefusion conformation with six
beneficial proline substitutions and by removal of the furin cleavage site. The vector is known to be safe and not only
express mRNA encoding SARS-CoV-2 spike protein, but also incorporates the spike
into virus particles, better mimicking immunity caused by natural exposure to
Safety and immunogenicity preclinical testing were
performed on a pig model by Avimex® in Mexico with the partial
funding of AMEXCID, which results were made available on September 21, 2021,
once they were peer reviewed in the renowned ASM Journal mBio as further reinforced with neutralization data against different variants
with the help of the world-class researchers of the Icahn School of Medicine at
Mount Sinai, in New York City.
The results showed that both intranasal and
intramuscular application of the vaccine as well as a combination of the two,
induce strong serum neutralizing antibody responses and a substantial
reactivity to Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) virus variants.
“Earlier versions of the vaccine were also
tested in rodents as inactivated and live vaccines; however, we chose to test these
vaccine candidates in a pig model because these animals are a large-animal
model that immunologically resemble humans better than the most common rodent
models”, said Dr. Bernardo Lozano Dubernard, General Director of Avimex®
and leader of the project in Mexico.
“These are very promising results that support
further clinical development of this vaccine, and represent the clinical
translation of a long, successful collaboration between Avimex® and the Icahn School of
Medicine at Mount Sinai in the area of veterinarian vaccines,” said Adolfo
Garcia-Sastre, PhD, Professor of Microbiology and Director of the Global Health
and Emerging Pathogens Institute at the Icahn School of Medicine at Mount
The study had limitations as the immune
response could not be assessed locally in the nasal mucosa or respiratory tract
of the vaccinated pigs, because appropriate sampling methods and standardized
tests to assess mucosal immunity are still a challenge in the pig model.
Furthermore, the porcine model is not susceptible to SARS-CoV-2 and a challenge
was not possible, but fortunately the vaccine was previously tested in other
animal models susceptible to challenge studies with excellent results.
Based on this data, a clinical trial (Phase 1) was initiated in May 2021
by Avimex® in Mexico with the support of the National Council for Science
and Technology (CONACyT). This was a first-in-human trial with a live rNDV
based vaccine which follows a unique protocol leading research worldwide by
including an intranasal route and a combination intranasal-intramuscular route.
The vaccine used was formulated in the Good-Manufacturing-Practices-approved Avimex®
pilot manufacturing facility.
The preliminary results from Phase I, which will continue for a full year,
have already been assessed and used to design and support two Phase II clinical
trials that are about to start. The preliminary results of Phase I will be
further analyzed and will include additional results from more detailed
immunological assays. Once finalized, the results will be published in a
peer-reviewed journal. Avimex® is committed to sharing these and all
the clinical trial results after they have been fully analyzed, under the
strictest ethical and scientific standards.
Since its foundation in 1952, Laboratorio Avi-Mex, S.A de
C.V., has been a bio-innovation company with 100% Mexican capital, which is
dedicated to the research, development, manufacture, import, export and
commercialization of biological and pharmaceutical products, disinfectants, and
mycotoxin detoxifiers for animal health. Today it has an important presence in
the market, both national and international, in more than 30 countries. As part
of its evolution, Avimex® has expanded its areas of expertise to
provide customers with solutions that improve the health and productivity of
animals intended for human consumption in poultry, swine, livestock, and
aquaculture sectors. This has granted it the recognition as a Family
Responsible Company (2006), Highly Exporting Company (2007), National Award for
Technology and Innovation (2011), ADIAT Award for Technological Innovation
(2012), National Export Award (2012), Ranking of the Best Mexican Companies
(2012-2021), National Award for Technology and Innovation Endorsement (2015),
Socially Responsible Company (2018-2021), and Super Companies by Expansión
(2018-2020). For more information, visit www.avimex.com.mx
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
academic medical system, encompassing eight hospitals, a leading medical
school, and a vast network of ambulatory practices throughout the greater New
York region. Mount Sinai is a national and international source of unrivaled
education, translational research and discovery, and collaborative clinical
leadership ensuring that we deliver the highest quality care—from prevention to
treatment of the most serious and complex human diseases. The Health System
includes more than 7,200 physicians and features a robust and continually
expanding network of multispecialty services, including more than 400
ambulatory practice locations throughout the five boroughs of New York City,
Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's
"Honor Roll" of the Top 20 Best Hospitals in the country and the
Icahn School of Medicine as one of the Top 20 Best Medical Schools in the
country. Mount Sinai Health System hospitals are consistently ranked regionally
by specialty and our physicians are in the top 1% of all physicians nationally
by U.S. News & World Report.
For more information,
visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and