AdJane, a clinical-stage vaccine platform company developing intranasal and intramuscular vaccines based on native Outer Membrane Vesicles (nOMVs), has published first-in-human Phase I clinical data in Vaccines, a peer-reviewed journal, demonstrating the ability of its proprietary nOMV platform to induce mucosal and systemic immune responses in humans
The first-in-human randomised, double-blind, placebo- and OMV-controlled trial in 40 healthy adults found that AdJane’s platform, combined with a SARS-CoV-2 Spike protein and administered intranasally, was safe and well tolerated and induced systemic and mucosal immune responses.
The combination triggered dose-dependent systemic immune responses across multiple measures, including virus-neutralising antibodies. The study also exhibited induction of immune activity at the nasal mucosa, the primary entry site for many respiratory pathogens.
The findings provide clinical proof of concept for AdJane’s nOMV platform and support its wider application across respiratory pathogens, pandemic preparedness scenarios, and other infectious disease targets under development.
Anita Gashi, managing director of AdJane, said, “This publication represents an important validation milestone for AdJane and our mucosal nOMV platform. Current injectable vaccines are highly effective at preventing severe disease but have shown limited ability to interrupt infection and transmission at the mucosal level. Our Phase I data demonstrate that intranasal OMV-based vaccination can safely induce both systemic and mucosal immunity in humans, supporting the potential of our platform as a next-generation approach for respiratory infectious diseases and pandemic preparedness.”
The COVID-19 pandemic revealed a major challenge in infectious disease control: while injectable vaccines can provide strong protection against severe disease and death, they generally induce limited immune protection in the upper respiratory tract, where many airborne pathogens initiate infection and transmission. This gap reduces the ability of conventional vaccines to limit person-to-person spread.
Mucosal vaccination approaches seek to address this challenge by generating immune responses at the site of pathogen entry and inducing broader systemic protection. As interest in transmission-blocking immunity and pandemic preparedness strategies grows, mucosal vaccination is increasingly recognised as an important emerging modality in vaccine development.
AdJane’s nOMV platform is designed to support rapid adaptation against emerging respiratory pathogens while enabling scalable and practical deployment strategies.
