Abstract
MEDI-534 is a bivalent live attenuated vaccine candidate against human respiratory syncytial virus (hRSV) and human parainfluenza virus type 3 (hPIV3) that was previously shown to be immunogenic and to protect rodents and African green monkeys from wild-type (wt) hRSV challenge. We performed further preclinical evaluations to address the safety of MEDI-534 prior to human testing. MEDI-534 did not predispose rodents to enhanced RSV disease following wt-RSV challenge, and the tissue tropism of the chimeric virus was confined to the respiratory tract. Representative clinical trial material did not produce toxicity in rats. In adults, MEDI-534 was highly restricted in replication, did not boost RSV and PIV3 antibody titers, and produced no medically significant vaccine-related adverse events thereby warranting further evaluation in pediatric populations.
Publication types
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Randomized Controlled Trial
MeSH terms
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Adolescent
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Adult
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Animals
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Chlorocebus aethiops
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Cricetinae
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Disease Models, Animal
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Double-Blind Method
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Female
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Genetic Vectors
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Humans
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Male
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Parainfluenza Vaccines* / administration & dosage
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Parainfluenza Vaccines* / genetics
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Parainfluenza Vaccines* / immunology
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Parainfluenza Virus 3, Human / genetics
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Parainfluenza Virus 3, Human / immunology*
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Rats
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Rats, Sprague-Dawley
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Respiratory Syncytial Virus Infections / immunology
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Respiratory Syncytial Virus Infections / prevention & control*
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Respiratory Syncytial Virus Infections / virology
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Respiratory Syncytial Virus Vaccines* / administration & dosage
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Respiratory Syncytial Virus Vaccines* / adverse effects
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Respiratory Syncytial Virus Vaccines* / immunology
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Respiratory Syncytial Virus, Human / immunology
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Respirovirus Infections / immunology
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Respirovirus Infections / prevention & control*
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Respirovirus Infections / virology
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Sigmodontinae
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Treatment Outcome
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Vaccines, Attenuated* / administration & dosage
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Vaccines, Attenuated* / adverse effects
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Vaccines, Attenuated* / immunology
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Vero Cells
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Young Adult
Substances
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Parainfluenza Vaccines
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Respiratory Syncytial Virus Vaccines
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Vaccines, Attenuated