ArticleNPJ vaccines2026
Safety, immunogenicity, and baseline immune correlates of vaccine JNJ-0535 in participants with or without CHB.
Article in NPJ vaccines, 2026. 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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Abstract
The role of T-cell-mediated immune responses is recognized as pivotal in achieving functional cure in chronic hepatitis B (CHB) patients. We aimed to assess safety and T-cell responses induced by JNJ-6430535 (JNJ-0535); a hepatitis B virus (HBV)-specific therapeutic DNA vaccine administered via electroporation-mediated intramuscular injection. JNJ-0535 comprises 2 plasmids, encoding HBV core and polymerase (pol) proteins, respectively. We describe the safety, tolerability, and immunogenicity results of JNJ-0535 from an open-label, single arm phase 1 study in healthy volunteers (HVs) (64300535HPB1003, NTC04736147) and a randomized, placebo controlled phase 1 study in CHB patients (64300535HPB1001, NTC03463369). HBV-specific T-cell responses were evaluated using enzyme-linked immunospot (ELISpot) and intracellular cytokine staining (ICS). We performed baseline single-cell RNA sequencing (scRNA-seq) to explore immune correlates associated with vaccine response in HVs, and baseline serum proteomics (Olink Explore
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