A randomized trial comparing safety, immunogenicity and efficacy of self-amplifying mRNA and adenovirus-vector COVID-19 vaccines
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.
Authors
- Carole Verhoeven
- Quang Chấn Lương (ORCID: https://orcid.org/0000-0002-1199-9484)
- Anh Thi Van Pham (ORCID: https://orcid.org/0000-0002-4975-1054)
- Nhan Thi Ho (ORCID: https://orcid.org/0000-0002-7898-0956)
- Xuan‐Hung Nguyen (ORCID: https://orcid.org/0000-0002-2216-8598)
- Rose E. Sekulovich (ORCID: https://orcid.org/0000-0002-7590-347X)
- Van Thu Nguyen (ORCID: https://orcid.org/0000-0003-2197-0455)
- Roberto Bugarini
- Steven G. Hughes
- Igor V. Smolenov (ORCID: https://orcid.org/0000-0002-7075-9827)
- Thượng Vũ Nguyễn (ORCID: https://orcid.org/0000-0003-0219-928X)
- Hong Thi Thuy Pham (ORCID: https://orcid.org/0009-0002-5576-4609)
- Dina Berdieva (ORCID: https://orcid.org/0000-0002-5019-2157)
- Anh Ngọc Nguyễn (ORCID: https://orcid.org/0000-0003-2753-2667)
- Xuexuan Liu (ORCID: https://orcid.org/0009-0004-3106-6114)
- Lydia Tran
- Anh Thi Van Luu
- Van Thanh Ta
Institutions
- Hanoi Medical University (VN)
- Institut Pasteur in Ho Chi Minh City (VN)
- Vinmec Times City International Hospital (VN)
- Arcturus Therapeutics (United States) (US)
- VinUniversity (VN)
Publication Details
- Journal
- npj Vaccines
- Published
- 2024-11-23
- DOI
- https://doi.org/10.1038/s41541-024-01017-5
- Citations
- 8
- Primary Topic
- SARS-CoV-2 and COVID-19 Research
- Type
- article
- Field-Weighted Citation Impact
- 3.11