Key result
Two doses of SW-BIC-213 mRNA vaccine elicit ~99% neutralizing-antibody seroconversion against wild-type SARS-CoV-2 versus placebo.
Why the study?
Although mRNA vaccines induce strong immune responses, delivery, biodistribution, and storage stability remain important considerations.
Does the SW-BIC-213 mRNA vaccine induce safe and immunogenic responses against SARS-CoV-2 in healthy adults?
RCT (n=521)
Double-blind
2:2:1 ratio
Does the SW-BIC-213 mRNA vaccine induce safe and immunogenic responses against SARS-CoV-2 in healthy adults?
Two doses of the SW-BIC-213 mRNA vaccine demonstrated an acceptable safety profile and substantial humoral immunogenicity against SARS-CoV-2 variants in healthy adults.
Answers are grounded in this paper and cite their sources.
Supports LPP-mRNA platform development in resource-limited settings; leaves open efficacy confirmation in phase 3 trials.
Background/Objectives: Messenger RNA vaccines can induce strong immune responses, but delivery, biodistribution, and storage stability remain important considerations. We evaluated the safety and immunogenicity of SW-BIC-213, a Lipo-Polyplex (LPP)-based mRNA vaccine against SARS-CoV-2, in healthy adults in Laos. Methods: We conducted a seamless phase 1/2 clinical trial in healthy adults. Phase 1 enrolled adults aged 18–60 years in an open-label, single-arm dose-escalation study; phase 2 enrolled adults aged ≥18 years in a randomized, double-blind, placebo-controlled study. Participants received two doses 21 days apart. The primary endpoints were safety in phase 1 and safety and immunogenicity in phase 2. Results: In phase 1, 41 participants received 25 or 45 μg of SW-BIC-213. In phase 2, 480 participants were randomized in a 2:2:1 ratio to receive 25 μg, 45 μg, or placebo. All phase 1 adverse reactions were grade 1 or 2; grade 3 reactions in phase 2 were limited to transient fever. At 14 days after the second dose, pseudovirus neutralizing-antibody seroconversion exceeded 99% against wild-type virus, 98% against Delta, 84% against Omicron BA.1, and 88% against BA.2. Neutralizing-antibody titers were higher in both vaccine groups than in the placebo group (p < 0.0001). Conclusions: Two doses of SW-BIC-213 showed an acceptable safety profile and substantial humoral immunogenicity in healthy adults aged ≥18 years.
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Yuan et al. (2026) conducted an RCT in Healthy adults (SARS-CoV-2 prevention) (n=521). SW-BIC-213 vs. Placebo was evaluated on Safety and immunogenicity (p=<0.0001). Two doses of SW-BIC-213 mRNA vaccine elicited >99% neutralizing-antibody seroconversion against wild-type SARS-CoV-2, with significantly higher titers than placebo (p<0.0001).
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