Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults
| Autor: | Toru Takimoto, Felicia Scaggs Huang, Michelle Dickey, Karen S. Slobod, David I. Bernstein, Allen Portner, Aya Nakamura, Bart G. Jones, Mat Makowski, Charles J. Russell, Christopher Coleclough, Julia L. Hurwitz, Kristen N Buschle, Kristen Branum, Robert E. Sealy, Michael M Meagher, Monica M. McNeal |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
respiratory syncytial virus parainfluenza virus viruses 030231 tropical medicine Immunology Short Report Respiratory Syncytial Virus Infections Antibodies Viral Sendai virus Virus 03 medical and health sciences Immunogenicity Vaccine 0302 clinical medicine vaccine Lower respiratory tract infection Chlorocebus aethiops Respiratory Syncytial Virus Vaccines Animals Humans Immunology and Allergy Medicine 030212 general & internal medicine Pharmacology biology business.industry Brief Report Immunogenicity virus diseases respiratory system biology.organism_classification medicine.disease Virology Parainfluenza Virus 1 Human Vaccination Human Parainfluenza Virus Intranasal Respiratory Syncytial Virus Human biology.protein Nasal administration Antibody business Viral Fusion Proteins |
| Zdroj: | Human Vaccines & Immunotherapeutics article-version (VoR) Version of Record |
| ISSN: | 2164-554X 2164-5515 |
| DOI: | 10.1080/21645515.2020.1779517 |
| Popis: | SeVRSV is a replication-competent Sendai virus (SeV)-based vaccine carrying the respiratory syncytial virus (RSV) fusion protein (F) gene. Unmanipulated, non-recombinant SeV is a murine parainfluenza virus type 1 (PIV-1) and serves as a Jennerian vaccine for human PIV-1 (hPIV-1). SeV protects African green monkeys (AGM) from infection after hPIV-1 challenge. The recombinant SeVRSV additionally targets RSV and protects AGM from lower respiratory infections after RSV challenge. The present study is the first to report on the safety, viral genome detection, and immunogenicity following SeVRSV vaccination of healthy adults. Seventeen and four healthy adults received intranasal SeVRSV and PBS, respectively, followed by six months of safety monitoring. Virus genome (in nasal wash) and vaccine-specific antibodies (in sera) were monitored for two and four weeks, respectively, post-vaccination. The vaccine was well-tolerated with only mild to moderate reactions that were also present in the placebo group. No severe reactions occurred. As expected, due to preexisting immunity toward hPIV-1 and RSV in adults, vaccine genome detection was transient. There were minimal antibody responses to SeV and negligible responses to RSV F. Results encourage further studies of SeVRSV with progression toward a clinical trial in seronegative children. Abbreviations: AE-adverse event; SAE-serious adverse event; SeV-Sendai virus; RSV-respiratory syncytial virus; PIV-1-parainfluenza virus-type 1; hPIV-1-human parainfluenza virus-type 1; F-RSV fusion protein; SeVRSV-recombinant SeV carrying the RSV F gene; Ab-antibody; MSW-medically significant wheezing; NOCMC-new onset chronic medical condition, mITT-modified Intent to Treat; ALRI-acute lower respiratory tract infection. |
| Databáze: | OpenAIRE |
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