Trial reportEBioMedicine2025
An open-label study on the safety and immunogenicity of a PD-1-enhanced DNA vaccine used as a T cell booster for COVID-19.
Trial report in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInducing T cell responses by vaccines among elderly has been a long-standing challenge. There is a need for effective COVID-19 vaccines to boost waning immunity against emerging SARS-CoV-2 variants, especially for the elderly. This study investigated the safety and immunogenicity of a PD-1-enhanced COVID-19 DNA vaccine (ICCOV™), as a booster vaccine in healthy adults (aged 18-59 years) and elderly (aged 60-75 years).
methodsThis open-label, non-randomised Phase 2 study enrolled healthy participants aged 18-75 years who had previously been vaccinated with Sinovac CoronaVac, Pfizer-bioNTech Comirnaty vaccines, or both. Participants were stratified into four cohorts according to age, primary vaccination, and COVID-19 infection history, namely Adult-CoronaVac, Adult-Comirnaty, Adult-Mixed, and Elderly-Mixed cohorts. Participants were administered with a single dose of 2 mg ICCOV intramuscularly followed by electroporation using the proprietary TERESA-EPT-I device. Participants were followed up for 60 days. The primary endpoint was T cell immunogenicity within 28 days post-ICCOV vaccination. The secondary endpoints were safety, T cell and antibody responses within 60 days post-vaccination (ClinicalTrials.govNCT05904054).
findingsThe study was conducted at Gleneagles Hospital Hong Kong between 30 June and 30 November 2023. In total, 31 participants were enrolled across the Adult-Comirnaty (n = 4), Adult-Mixed (n = 15), and Elderly-Mixed (n = 12) cohorts. All enrolled participants completed the study and were included in safety and immunogenicity analyses. Among these participants, 2 from the Adult-Comirnaty cohort, 9 from the Adult-Mixed cohort, and 4 from the Elderly-Mixed cohort reported a total of 31 adverse events, all in grade 1-2. Pain at the administration site was the most frequently reported (38·7%). The proportion of participants demonstrating an increase of SARS-CoV-2-specific ELISpot T cell responses within 28 days post ICCOV vaccination was 100% (4/4), 80% (12/15), and 75% (9/12) in Adult-Comirnaty, Adult-Mixed, and Elderly-Mixed cohorts, respectively. Single ICCOV vaccination elicited SARS-CoV-2-specific, polyfunctional CD8
interpretationSingle PD-1-enhanced ICCOV booster DNA vaccination did not show major safety concerns. The ICCOV booster elicited cross-reactive T cell responses to multiple SARS-CoV-2 strains, including in the elderly. This report demonstrates the T-cell boosting immunogenicity of ICCOV in the susceptible elderly population.
fundingClinical Translational Catalyst, Hong Kong Science & Technology Parks Corporation.
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