Novavax RSV F Vaccine is Highly Immunogenic With Robust Transplacental Antibody Transfer in Preclinical Maternal Immunization Model
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Sept. 15, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced its RSV F-protein recombinant nanoparticle vaccine
candidate (RSV F Vaccine) was shown to be highly immunogenic in a guinea pig
model of maternal immunization. The preclinical study was published in the
journal Vaccine.(1)
Direct immunization of infants is complicated by their immature immune systems
which are unable to fight off viral infection early in life when infants are
most vulnerable to RSV. In mammals, the passage of maternal antibodies to
offspring is largely achieved either by in utero transplacental transfer of
immunoglobulin G antibodies (IgG) or by postpartum breast-feeding of colostral
milk containing high levels of IgG and sIgA.(2) For human infants, maternally-
derived IgG appears to be provided entirely in utero, via transplacental Fc
receptor-mediated antibody transfer.(2) The protective effects of human serum
IgG, transferred from mothers to infants in utero,(2) against a number of
infections, including influenza and pertussis, has been well-described.(3-5)
Presumptive pregnant guinea pigs were immunized with the RSV F Vaccine on
gestational days 25 and 46. The vaccine induced high levels of anti-F IgG
antibodies, palivizumab-competing antibodies (PCA) and microneutralizing titers.
The peer-reviewed manuscript also demonstrates transfer of placental anti-RSV
antibodies, as measured by a number of immunoassays, at days 15 and 30
postpartum.
"RSV is the leading cause of infant hospitalizations in the U.S. and a
significant unmet need in full-term infants," said Gregory M. Glenn, M.D.,
Senior Vice President, Research and Development at Novavax. "The placental
architecture in guinea pigs reflects the anatomy found in humans, making them an
appropriate model to evaluate placental transfer of antibodies. These
preclinical data further support our RSV F Vaccine maternal immunization
program, and we look forward to announcing data from our Phase 2 clinical trial
to protect infants via maternal immunization this quarter."
Copies of this paper are available to credentialed journalists upon request;
please contact Elsevier's Newsroom at newsroom(at)elsevier.com or +31 20 4853564.
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory
tract infections and the leading viral cause of severe lower respiratory tract
disease in infants and young children worldwide, with estimated annual infection
and mortality rates of 64 million and 160,000, respectively.(6) In the US, RSV
is responsible for approximately 57,000 hospitalizations of children under five
years of age annually, the vast majority of which occur in infants less than one
year old, and especially those under six months of age.(7-11) Despite the
induction of post-infectious immunity, repeat infection and lifelong
susceptibility is common.(12) Currently, there is no approved RSV vaccine
available. Palivizumab is a monoclonal antibody, licensed and sold by MedImmune
as Synagis(®), that targets the RSV F protein and is used for prophylaxis
against RSV disease in high risk infants.
About Vaccine
Vaccine is the pre-eminent journal for those interested in vaccines and
vaccination. It is the official journal of The Edward Jenner Society, The
International Society for Vaccines and The Japanese Society for Vaccinology and
is published by Elsevier. www.elsevier.com/locate/vaccine
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global health through
safe and effective vaccines. Additional information about Novavax is available
on the company's website, novavax.com.
References:
1. "Modeling Maternal Fetal RSV F Vaccine Induced Antibody Transfer in Guinea
Pigs," by Gregory M. Glenn, Louis F. Fries, Gale Smith, Eloi Kpamegan,
Hanxin Lu, Mimi Guebre-Xabier, Somia P. Hickman, and David Flyer. DOI:
10.1016/j.vaccine.2015.08.039. It appears in Vaccine, In Press, 2015,
published by Elsevier.
2. "Comparative placental structure," by A.C. Enders, T.N. Blankenship. Adv
Drug Delivery Rev, 38 (1999), pp. 3-15.
3. "The protective role of maternally derived antibodies against Bordetella
pertussis in young infants," by U. Heininger et al. Pediatr Infect Dis J,
32 (2013), pp. 695-698.
4. "Influenza vaccination of pregnant women and protection of their infants,"
by S.A. Madhi et al. N Engl J Med, 371 (2014), p. 2340.
5. "Neonatal outcomes after influenza immunization during pregnancy: a
randomized controlled trial." by M.C. Steinhoff et al. CMAJ 184 (2012), pp.
645-653.
6. "Global burden of acute lower respiratory infections due to respiratory
syncytial virus in young children: a systematic review and meta-analysis,"
by Nair, H. et al. Lancet, 2010; 375: 1545-1555.
7. "Respiratory syncytial virus-associated hospitalizations among infants and
young children in the United States, 1997-2006," by L.J. Stockman et al.
Pediatr Infect Dis J, 2012; 31:5-9.
8. Centers for Disease Control and Prevention, update May 5, 2015. Respiratory
Syncytial Virus Infection. Trends and Surveillance.
http://www.cdc.gov/rsv/research/us-surveillance.html
9. "Rates of hospitalization for respiratory syncytial virus infection among
children in Medicaid," by T.G. Boyce et al. J Pediatr, 2000; 137:865-870.
10. "The Burden of Respiratory Syncytial Virus Infection in Young Children," by
C.B. Hall Hall et al. N Engl J Med, 2009; 360(6): 588-98.
11. "Respiratory Syncytial Virus-Associated hospitalizations Among Children
Less Than 24 Months of Age." by C.B. Hall et al. Pediatrics, 2013; 132(2):
E341-348.
12. "Risk of primary infection and reinfection with respiratory syncytial
virus," by W.P. Glezen et al. Am J Dis Child, 1986; 140:543-546.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir(at)novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(at)russopartnersllc.com
todd.davenport(at)russopartnersllc.com
212-845-4271
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Source: Novavax, Inc. via GlobeNewswire
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Datum: 15.09.2015 - 22:30 Uhr
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