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. 2021 Feb 1;17(2):554-559.
doi: 10.1080/21645515.2020.1779517. Epub 2020 Aug 4.

Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults

Felicia Scaggs Huang  1 , David I Bernstein  1 , Karen S Slobod  2 , Allen Portner  2 , Toru Takimoto  2 , Charles J Russell  2   3 , Michael Meagher  4 , Bart G Jones  2 , Robert E Sealy  2 , Christopher Coleclough  2 , Kristen Branum  2 , Michelle Dickey  1 , Kristen Buschle  1 , Monica McNeal  1 , Mat Makowski  5 , Aya Nakamura  5 , Julia L Hurwitz  2   3
Affiliations

Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults

Felicia Scaggs Huang et al. Hum Vaccin Immunother. .

Abstract

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.

Keywords: Intranasal; parainfluenza virus; respiratory syncytial virus; vaccine.

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Figures

Figure 1.
Figure 1.
Detection of SeV or RSV F protien sequence by PCR
Figure 2.
Figure 2.
Antibody responses toward SeV and RSV F
See this image and copyright information in PMC

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