A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines
Abstract This phase 3 trial compared safety, tolerability, immunogenicity and efficacy of the self-amplifying mRNA COVID-19 vaccine, ARCT-154, with ChAdOx1-S adenovirus-vector vaccine. In four centers in Vietnam adult participants aged 18‒85 years were randomly assigned to receive two doses, 28 days...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-11-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-024-01017-5 |
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| author | Nhan Thi Ho Steve G. Hughes Rose Sekulovich Van Thanh Ta Thuong Vu Nguyen Anh Thi Van Pham Quang Chan Luong Ly Thi Le Tran Anh Thi Van Luu Anh Ngoc Nguyen Ha Thai Pham Van Thu Nguyen Dina Berdieva Roberto Bugarini Xuexuan Liu Carole Verhoeven Igor Smolenov Xuan-Hung Nguyen |
| author_facet | Nhan Thi Ho Steve G. Hughes Rose Sekulovich Van Thanh Ta Thuong Vu Nguyen Anh Thi Van Pham Quang Chan Luong Ly Thi Le Tran Anh Thi Van Luu Anh Ngoc Nguyen Ha Thai Pham Van Thu Nguyen Dina Berdieva Roberto Bugarini Xuexuan Liu Carole Verhoeven Igor Smolenov Xuan-Hung Nguyen |
| author_sort | Nhan Thi Ho |
| collection | DOAJ |
| description | Abstract This phase 3 trial compared safety, tolerability, immunogenicity and efficacy of the self-amplifying mRNA COVID-19 vaccine, ARCT-154, with ChAdOx1-S adenovirus-vector vaccine. In four centers in Vietnam adult participants aged 18‒85 years were randomly assigned to receive two doses, 28 days apart, of either ARCT-154 (n = 1186) or ChAdOx1-S (n = 1180). Both vaccines were well tolerated with similar safety and reactogenicity profiles consisting of mainly mild-to-moderate solicited adverse events and few related serious adverse events. Higher neutralizing antibody responses persisting to one-year post-vaccination after ARCT-154 compared with ChAdOx1-S were associated with a generally higher efficacy against COVID-19. In an exploratory analysis relative vaccine efficacy of ARCT-154 vs. ChAdOx1-S against any COVID-19 from Day 36 to Day 394 was 19.8% (95% CI: 4.0–33.0). Self-amplifying mRNA vaccine offers potential immunological advantages in terms of immunogenicity and efficacy over adenovirus-vector vaccine without compromising safety. |
| format | Article |
| id | doaj-art-fdddba0ead384e6c8dc2db3519c6fd32 |
| institution | Kabale University |
| issn | 2059-0105 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj-art-fdddba0ead384e6c8dc2db3519c6fd322024-11-24T12:09:40ZengNature Portfolionpj Vaccines2059-01052024-11-019111010.1038/s41541-024-01017-5A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccinesNhan Thi Ho0Steve G. Hughes1Rose Sekulovich2Van Thanh Ta3Thuong Vu Nguyen4Anh Thi Van Pham5Quang Chan Luong6Ly Thi Le Tran7Anh Thi Van Luu8Anh Ngoc Nguyen9Ha Thai Pham10Van Thu Nguyen11Dina Berdieva12Roberto Bugarini13Xuexuan Liu14Carole Verhoeven15Igor Smolenov16Xuan-Hung Nguyen17Research Management Department, Vinmec Healthcare SystemArcturus Therapeutics, Inc.Arcturus Therapeutics, Inc.Hanoi Medical UniversityPasteur InstituteHanoi Medical UniversityPasteur InstituteVietnam Biocare Biotechnology Jointstock CompanyVietnam Biocare Biotechnology Jointstock CompanyVietnam Biocare Biotechnology Jointstock CompanyVietnam Biocare Biotechnology Jointstock CompanyVietnam Biocare Biotechnology Jointstock CompanyArcturus Therapeutics, Inc.Arcturus Therapeutics, Inc.Arcturus Therapeutics, Inc.Arcturus Therapeutics, Inc.Arcturus Therapeutics, Inc.Vinmec-VinUni Institute of Immunology, VinUniversityAbstract This phase 3 trial compared safety, tolerability, immunogenicity and efficacy of the self-amplifying mRNA COVID-19 vaccine, ARCT-154, with ChAdOx1-S adenovirus-vector vaccine. In four centers in Vietnam adult participants aged 18‒85 years were randomly assigned to receive two doses, 28 days apart, of either ARCT-154 (n = 1186) or ChAdOx1-S (n = 1180). Both vaccines were well tolerated with similar safety and reactogenicity profiles consisting of mainly mild-to-moderate solicited adverse events and few related serious adverse events. Higher neutralizing antibody responses persisting to one-year post-vaccination after ARCT-154 compared with ChAdOx1-S were associated with a generally higher efficacy against COVID-19. In an exploratory analysis relative vaccine efficacy of ARCT-154 vs. ChAdOx1-S against any COVID-19 from Day 36 to Day 394 was 19.8% (95% CI: 4.0–33.0). Self-amplifying mRNA vaccine offers potential immunological advantages in terms of immunogenicity and efficacy over adenovirus-vector vaccine without compromising safety.https://doi.org/10.1038/s41541-024-01017-5 |
| spellingShingle | Nhan Thi Ho Steve G. Hughes Rose Sekulovich Van Thanh Ta Thuong Vu Nguyen Anh Thi Van Pham Quang Chan Luong Ly Thi Le Tran Anh Thi Van Luu Anh Ngoc Nguyen Ha Thai Pham Van Thu Nguyen Dina Berdieva Roberto Bugarini Xuexuan Liu Carole Verhoeven Igor Smolenov Xuan-Hung Nguyen A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines npj Vaccines |
| title | A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines |
| title_full | A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines |
| title_fullStr | A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines |
| title_full_unstemmed | A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines |
| title_short | A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines |
| title_sort | randomized trial comparing safety immunogenicity and efficacy of self amplifying mrna and adenovirus vector covid 19 vaccines |
| url | https://doi.org/10.1038/s41541-024-01017-5 |
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