A phase I, needle free, dose escalation clinical trial of pEVAC-PS, a candidate pan-Sarbecovirus Vaccine
Journal of Infection·
- DOI
- 10.1016/j.jinf.2026.106759
- PMID
- 42155675
- PMCID
- —
- OpenAlex
- W4409983444
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
This candidate demonstrates feasibility of a computationally designed pan-Sarbecovirus vaccine approach that could potentially address multiple coronaviruses, including future zoonotic spillovers. The thermostable, needle-free delivery platform may support deployment in resource-limited settings.
Structured evidence summary
Research question
This Phase I trial evaluated the safety, tolerability, and immunogenicity of pEVAC-PS, a computationally designed pan-Sarbecovirus vaccine candidate intended to induce broad cross-protection against SARS, SARS-CoV-2, and related coronaviruses with zoonotic potential.
Study design
An open-label Phase I dose escalation trial administered the DNA vaccine via needle-free intradermal delivery at four dose levels (0.2 to 1.2 mg) on days 0 and 28. Primary outcomes assessed safety and reactogenicity; secondary outcomes measured humoral immunogenicity at day 56.
Population and setting
Thirty-nine healthy volunteers aged 18 to 50, previously vaccinated with two or three COVID-19 doses and without recent confirmed infection, were enrolled sequentially across cohorts between December 2021 and September 2023.
Main findings
The vaccine was well tolerated at all dose levels with no significant safety concerns. Participants developed measurable responses to conserved sarbecovirus epitopes encoded by the vaccine. However, interpretation of immunogenicity was complicated by high baseline antibody levels and ongoing Omicron variant transmission during recruitment.
Public-health relevance
This candidate demonstrates feasibility of a computationally designed pan-Sarbecovirus vaccine approach that could potentially address multiple coronaviruses, including future zoonotic spillovers. The thermostable, needle-free delivery platform may support deployment in resource-limited settings.
Important limitations
The immunogenicity findings are limited by high pre-existing immunity from prior vaccination and infection, heterogeneous exposure histories across cohorts, and ongoing Omicron variant circulation during enrollment, which introduced unavoidable immune bias affecting interpretation of vaccine-induced responses.
GIDS interpretation
This first-in-human data supports proceeding to further evaluation of this antigen design strategy; however, these early-phase findings cannot be generalized beyond the studied population or interpreted as confirmatory of protective efficacy against specific sarbecovirus threats. The study was not designed to evaluate effectiveness against any particular surveillance signal or outbreak context.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 13 auditable classifier relationships to diseases, places, topics, and study design.