First potential immunization against RSV for healthy infants found
highly effective in phase 3 trial
Single dose of nirsevimab protected infants across the entire RSV season


Date:
March 3, 2022
Source:
Ann & Robert H. Lurie Children's Hospital of Chicago
Summary:
Nirsevimab showed 74.5 percent efficacy against medically attended
lower respiratory tract infections caused by respiratory syncytial
virus (RSV) in healthy infants, according to an international,
randomized, placebo- controlled Phase 3 clinical trial. It is the
first potential immunization against RSV in the general infant
population, with a single dose providing safe protection across
the entire RSV season.



FULL STORY ========================================================================== Nirsevimab showed 74.5 percent efficacy against medically attended lower respiratory tract infections caused by respiratory syncytial virus
(RSV) in healthy infants, according to an international, randomised, placebo-controlled Phase 3 clinical trial. It is the first potential immunization against RSV in the general infant population, with a single
dose providing safe protection across the entire RSV season. Results
were published in the New England Journal of Medicine.


========================================================================== "These exciting data show that nirsevimab has the potential to offer
RSV protection for all infants, which would be a paradigm shift in
the approach to this disease," said site Principal Investigator and
co-author William Muller, MD, PhD, Scientific Director of Clinical and Community Trials at Stanley Manne Children's Research Institute at Ann &
Robert H. Lurie Children's Hospital of Chicago, and Associate Professor
of Pediatrics at Northwestern University Feinberg School of Medicine.

RSV is a common, contagious virus that causes seasonal epidemics of lower respiratory tract infections, leading to bronchiolitis and pneumonia in infants. It is also a leading cause of hospitalizations in all infants.

The trial involved healthy term and late preterm (gestational age ?35
weeks) infants entering their first RSV season. Lurie Children's was
among the highest enrolling US sites in the trial.

Nirsevimab is an investigational long-acting monoclonal antibody, being developed by AstraZeneca and Sanofi, designed to protect all infants
through their first RSV season with a single dose. Monoclonal antibodies
do not require the activation of the immune system to help offer rapid
and direct protection against disease.

Currently, the only available preventative option for RSV is palivizumab,
which is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season.

A separate Phase 2/3 trial, also published in the New England Journal
of Medicine, which evaluated the safety of nirsevimab in infants with congenital heart disease, chronic lung disease and prematurity entering
their first RSV season, demonstrated that nirsevimab had a similar
safety and tolerability profile compared to palivizumab.Results in this population of infants indicated similar protection against RSV to that
in the healthy term and late preterm infants.

"We know that RSV has seen a resurgence with the easing of COVID-19 public health measures. This shows us a broad immunization approach is needed
to help mitigate the substantial global burden RSV places on infants,
their families and healthcare services," said Dr. Muller.

Research at Ann & Robert H. Lurie Children's Hospital of Chicago is
conducted through the Stanley Manne Children's Research Institute. The
Manne Research Institute is focused on improving child health,
transforming pediatric medicine and ensuring healthier futures through
the relentless pursuit of knowledge.

Lurie Children's is ranked as one of the nation's top children's hospitals
by U.S. News & World Report.It is the pediatric training ground for Northwestern University Feinberg School of Medicine.


========================================================================== Story Source: Materials provided by Ann_&_Robert_H._Lurie_Children's_Hospital_of_Chicago.

Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Laura L. Hammitt, Ron Dagan, Yuan Yuan, Manuel Baca Cots, Miroslava
Bosheva, Shabir A. Madhi, William J. Muller, Heather J. Zar, Dennis
Brooks, Amy Grenham, Ulrika Wa"hlby Hamre'n, Vaishali S. Mankad,
Pin Ren, Therese Takas, Michael E. Abram, Amanda Leach, M. Pamela
Griffin, Tonya Villafana. Nirsevimab for Prevention of RSV in
Healthy Late-Preterm and Term Infants. New England Journal of
Medicine, 2022; 386 (9): 837 DOI: 10.1056/NEJMoa2110275 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/03/220303095654.htm

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