Phase I results provide platform-level validation supporting AdJane's broader development programs in pandemic preparedness, respiratory infectious diseases and antimicrobial resistance

AdJane, a clinical-stage vaccine platform company developing intranasal and intramuscular vaccines based on native Outer Membrane Vesicles (nOMVs), announces the publication of first-in-human Phase I clinical data in the peer-reviewed journal Vaccines, demonstrating the ability of its proprietary nOMV platform to induce both mucosal and systemic immune responses in humans.

The first-in-human randomized, double-blind, placebo- and OMV-controlled trial in 40 healthy adults demonstrated that AdJane's platform, combined with a SARS-CoV-2 Spike protein and administered intranasally, was safe and well tolerated and induced both systemic and mucosal immune responses. The combination triggered dose-dependent systemic immune responses across multiple measures, including virus-neutralizing antibodies. Importantly, the study showed 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 broader application across respiratory pathogens, pandemic preparedness scenarios, and other infectious disease targets currently under development.

"This publication represents an important validation milestone for AdJane and our mucosal nOMV platform," said Anita Gashi, Managing Director of AdJane. "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."

Addressing the Mucosal Immunity Gap in Vaccines for Respiratory Infections

The COVID-19 pandemic highlighted 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 aim to address this limitation by generating immune responses directly at the site of pathogen entry, while also inducing broader systemic protection. As interest in transmission-blocking immunity and pandemic preparedness strategies continues to grow globally, mucosal vaccination is increasingly recognized 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.