SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial
Abstract
SUMMARY A self-assembling SARS-CoV-2 recombinant spike ferritin nanoparticle (SpFN) vaccine co-formulated with Army Liposomal Formulation (ALFQ) adjuvant containing monophosphoryl lipid A and QS-21 (SpFN/ALFQ) has demonstrated protective efficacy in animal challenge models. We report the first-in-human randomized, double-blind, placebo-controlled clinical trial (NCT04784767) of SpFN/ALFQ. Methods SARS-CoV-2 seronegative and unvaccinated adults were randomly assigned (5:5:2) to receive 25μg or 50μg of SpFN/ALFQ or saline placebo intramuscularly at days 1 and 29, with, an optional open-label third vaccination at day 181. Local and systemic reactogenicity, adverse events, binding (BAb) and neutralizing antibodies (NAb) and antigen-specific T-cell responses were quantified. For safety analyses, exact 95% Clopper-Pearson confidence intervals (CIs) for the probability of any incidence of each reported unsolicited adverse event was computed for each group. For immunogenicity results, CIs for binary variables were computed using the exact Clopper-Pearson methodology, while CIs for geometric mean titer were based on 10,000 empirical bootstrap samples. Post hoc, paired one-sample t-tests were used to assess the increase in mean log-10 Nab titers between days 29 and 43 (post-second vaccination) for the primary SARS-CoV-2 targets of interest. Findings Twenty-nine participants were enrolled between April 7, 2021 and June 29, 2021. Neutralizing antibody responses peaked at day 43,…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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