Matches in SemOpenAlex for { <https://semopenalex.org/work/W4366819005> ?p ?o ?g. }
- W4366819005 endingPage "104586" @default.
- W4366819005 startingPage "104586" @default.
- W4366819005 abstract "We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults.We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355).Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group.SW-BIC-213, a core-shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults.Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai." @default.
- W4366819005 created "2023-04-25" @default.
- W4366819005 creator A5006219225 @default.
- W4366819005 creator A5015533929 @default.
- W4366819005 creator A5018453695 @default.
- W4366819005 creator A5022768852 @default.
- W4366819005 creator A5023548161 @default.
- W4366819005 creator A5024098878 @default.
- W4366819005 creator A5026989610 @default.
- W4366819005 creator A5029634246 @default.
- W4366819005 creator A5031371726 @default.
- W4366819005 creator A5038725556 @default.
- W4366819005 creator A5045319624 @default.
- W4366819005 creator A5047172309 @default.
- W4366819005 creator A5049507373 @default.
- W4366819005 creator A5060575663 @default.
- W4366819005 creator A5065859286 @default.
- W4366819005 creator A5065967463 @default.
- W4366819005 creator A5067621466 @default.
- W4366819005 creator A5071077743 @default.
- W4366819005 creator A5076291631 @default.
- W4366819005 creator A5077645027 @default.
- W4366819005 creator A5084843280 @default.
- W4366819005 creator A5086981177 @default.
- W4366819005 creator A5087168365 @default.
- W4366819005 date "2023-05-01" @default.
- W4366819005 modified "2023-09-30" @default.
- W4366819005 title "Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial" @default.
- W4366819005 cites W3043722389 @default.
- W4366819005 cites W3048620154 @default.
- W4366819005 cites W3090717270 @default.
- W4366819005 cites W3092766467 @default.
- W4366819005 cites W3108610942 @default.
- W4366819005 cites W3111255098 @default.
- W4366819005 cites W3127329393 @default.
- W4366819005 cites W3154648093 @default.
- W4366819005 cites W3164764657 @default.
- W4366819005 cites W3174017401 @default.
- W4366819005 cites W3178010802 @default.
- W4366819005 cites W3192494915 @default.
- W4366819005 cites W3215521526 @default.
- W4366819005 cites W3215964500 @default.
- W4366819005 cites W4205240144 @default.
- W4366819005 cites W4205483821 @default.
- W4366819005 cites W4206906464 @default.
- W4366819005 cites W4211259701 @default.
- W4366819005 cites W4220905041 @default.
- W4366819005 cites W4280562953 @default.
- W4366819005 cites W4281571659 @default.
- W4366819005 cites W4281771243 @default.
- W4366819005 cites W4281843570 @default.
- W4366819005 cites W4282928458 @default.
- W4366819005 cites W4284976243 @default.
- W4366819005 cites W4291002736 @default.
- W4366819005 cites W4292227878 @default.
- W4366819005 cites W4296026861 @default.
- W4366819005 cites W4316496291 @default.
- W4366819005 doi "https://doi.org/10.1016/j.ebiom.2023.104586" @default.
- W4366819005 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37099843" @default.
- W4366819005 hasPublicationYear "2023" @default.
- W4366819005 type Work @default.
- W4366819005 citedByCount "3" @default.
- W4366819005 countsByYear W43668190052023 @default.
- W4366819005 crossrefType "journal-article" @default.
- W4366819005 hasAuthorship W4366819005A5006219225 @default.
- W4366819005 hasAuthorship W4366819005A5015533929 @default.
- W4366819005 hasAuthorship W4366819005A5018453695 @default.
- W4366819005 hasAuthorship W4366819005A5022768852 @default.
- W4366819005 hasAuthorship W4366819005A5023548161 @default.
- W4366819005 hasAuthorship W4366819005A5024098878 @default.
- W4366819005 hasAuthorship W4366819005A5026989610 @default.
- W4366819005 hasAuthorship W4366819005A5029634246 @default.
- W4366819005 hasAuthorship W4366819005A5031371726 @default.
- W4366819005 hasAuthorship W4366819005A5038725556 @default.
- W4366819005 hasAuthorship W4366819005A5045319624 @default.
- W4366819005 hasAuthorship W4366819005A5047172309 @default.
- W4366819005 hasAuthorship W4366819005A5049507373 @default.
- W4366819005 hasAuthorship W4366819005A5060575663 @default.
- W4366819005 hasAuthorship W4366819005A5065859286 @default.
- W4366819005 hasAuthorship W4366819005A5065967463 @default.
- W4366819005 hasAuthorship W4366819005A5067621466 @default.
- W4366819005 hasAuthorship W4366819005A5071077743 @default.
- W4366819005 hasAuthorship W4366819005A5076291631 @default.
- W4366819005 hasAuthorship W4366819005A5077645027 @default.
- W4366819005 hasAuthorship W4366819005A5084843280 @default.
- W4366819005 hasAuthorship W4366819005A5086981177 @default.
- W4366819005 hasAuthorship W4366819005A5087168365 @default.
- W4366819005 hasBestOaLocation W43668190051 @default.
- W4366819005 hasConcept C121332964 @default.
- W4366819005 hasConcept C12590561 @default.
- W4366819005 hasConcept C126322002 @default.
- W4366819005 hasConcept C1276947 @default.
- W4366819005 hasConcept C142724271 @default.
- W4366819005 hasConcept C159654299 @default.
- W4366819005 hasConcept C168563851 @default.
- W4366819005 hasConcept C197934379 @default.
- W4366819005 hasConcept C203014093 @default.
- W4366819005 hasConcept C203092338 @default.