Nasal COVID-19 vaccine based on WashU technology to enter U.S. clinical trials
by Tamara Schneider•
A nasal vaccine for COVID-19 – based on technology developed
at Washington University in St. Louis – is poised to enter a phase 1 clinical
trial in the U.S. after an investigational new drug application from Ocugen,
Inc. was approved by the Food and Drug Administration (FDA). Ocugen, a
U.S.-based biotechnology company, licensed the innovative technology from WashU
in 2022.
The trial will be sponsored and conducted by the National
Institute of Allergy and Infectious Diseases (NIAID), of the National
Institutes of Health (NIH). The FDA’s action is a critical first step toward
initiation of the phase 1 trial, planned for this spring.
While cases of COVID-19 have fallen dramatically since the
early years of the pandemic, the virus continues to circulate and still causes
significant illnesses and deaths. The nasal vaccine technology is designed to
induce strong immunity in the nose and upper respiratory tract, right where the
virus enters the body, thereby potentially stopping transmission of the virus
in addition to reducing serious illness and death. Most COVID-19 vaccines are
injected into the arm or leg, and while they are effective at reducing illness
and death, they do not halt transmission. The new trial will evaluate the
safety and efficacy of the vaccine administered via two routes: inhaled into
the lungs and sprayed into the nose.
“I am delighted to see this nasal vaccination technology, created by scientists right here at WashU Medicine, advance toward clinical trials,” said Doug E. Frantz, PhD, the Vice Chancellor for Innovation and Commercialization at WashU. “This powerful technology has the potential not only to help control COVID-19 but to reduce the burden of respiratory infections worldwide. The technology could be adapted for other common respiratory viruses such as seasonal influenza, avian flu and respiratory syncytial virus (RSV) that cause enormous sickness and death.”
A version of the vaccine has been available in India since 2022 through
a licensing agreement between WashU and the Indian biotechnology company Bharat
Biotech.
The Phase 1 trial is funded through Project NextGen, a U.S. government agency
initiative to develop next-generation COVID-19 vaccines and therapeutics
through public-private partnerships.
The trial will enroll 80 adults ages 18 to 64 years.
Participants will be randomly assigned to one of four groups: low-dose
intranasal, high-dose intranasal, low-dose inhaled and high-dose inhaled. The
primary aim of the trial is to determine safety, but researchers will also
assess immunogenicity by measuring antibody production and efficacy by
determining the number of breakthrough COVID-19 cases.
The investigational nasal vaccine was co-developed by WashU
Medicine scientists Michael S. Diamond, MD, PhD, the Herbert S.
Gasser Professor of Medicine and the co-director of the Center for Vaccines
& Immunity to Microbial Pathogens, and David T. Curiel, MD, PhD, the Distinguished
Professor of Radiation Oncology, along with members of their laboratories.
Diamond and Curiel inserted a gene from SARS-CoV-2, the
virus that causes COVID-19, into a harmless virus known as an adenovirus. The
adenovirus carries the SARS-CoV-2 protein into the nose, enabling people to
mount an immune defense against the SARS-CoV-2 virus without becoming sick.
“It is gratifying to see the vaccine that we conceived,
designed and conducted initial testing on move closer to becoming available
here in the U.S.,” said Diamond, also a professor of molecular microbiology and
of pathology & immunology.
Diamond and Curiel’s early studies at WashU Medicine showed
that nasal delivery of this vaccine creates a strong immune response throughout
the body, especially in the nose and respiratory tract. In animal studies
conducted in 2020 and 2021, the nasal vaccine entirely prevented infection from
taking hold in the nose and lungs — suggesting that vaccinated individuals
would be able to fend off the virus before it could multiply and cause an
infection. Last year, Jacco Boon, PhD, a professor of medicine,
of molecular microbiology and of pathology & immunology at WashU Medicine,
showed that hamsters vaccinated with the nasal COVID-19 vaccine and
subsequently infected did not pass the virus on to others,
breaking the cycle of transmission.
“All effective vaccines reduce sickness and death, but
COVID-19 vaccination through the nose and mouth also seems to reduce
transmission,” said Curiel, also a professor of medicine and of obstetrics
& gynecology. “This capability is critical in slowing the spread of
respiratory infections such as COVID-19 through a population, and the same
vaccine technology can be designed to target other COVID-19 strains as well as
influenza and other respiratory viruses.”
