DELFT, The Netherlands, June 30, 2026
AdJane, a clinical-stage vaccine platform company, has announced the publication of first-in-human Phase I clinical trial results validating its proprietary native Outer Membrane Vesicle (nOMV) vaccine platform, demonstrating its ability to safely induce both mucosal and systemic immunity in humans. Published in the peer-reviewed journal Vaccines, the findings represent a significant milestone in the advancement of next-generation vaccines designed to combat respiratory infectious diseases, strengthen pandemic preparedness, and address the growing threat of antimicrobial resistance. The randomized, double-blind, placebo- and OMV-controlled Phase I study evaluated the company’s intranasal vaccine platform in healthy adults using a SARS-CoV-2 Spike protein and confirmed the induction of immune responses at both the body’s systemic level and the nasal mucosa, the primary entry point for many airborne pathogens. The successful clinical validation provides proof-of-concept for AdJane’s modular vaccine platform and supports its continued development across multiple infectious disease programs.
Phase I Trial Demonstrates Strong Mucosal and Systemic Immunity
The Phase I clinical trial enrolled 40 healthy SARS-CoV-2 seropositive adults aged 18 to 55 years in a randomized, double-blind, placebo- and OMV-controlled study designed to evaluate the safety and immunogenicity of AdJane’s intranasal nOMV vaccine platform. Results showed that the vaccine candidate was safe and well tolerated, while producing dose-dependent systemic immune responses, including the generation of virus-neutralizing antibodies. Most importantly, researchers observed immune activation within the nasal mucosa, providing evidence that the vaccine stimulates protective immunity directly at the site where many respiratory viruses first establish infection.
This capability addresses one of the major limitations of conventional injectable vaccines, which are highly effective at preventing severe illness but generally provide limited protection against infection and transmission in the upper respiratory tract. By successfully inducing both mucosal immunity and systemic immune protection, AdJane’s platform represents a promising advancement in next-generation vaccine technology capable of reducing disease transmission while maintaining strong protective immunity.
Innovative OMV Platform Supports Rapid Vaccine Development
Advertisement
AdJane’s native Outer Membrane Vesicle (nOMV) platform has been developed through more than 30 years of scientific research originating from leading Dutch governmental research institutions. The technology utilizes native outer membrane vesicles derived from Neisseria meningitidis bacteria, which naturally stimulate immune responses while closely mimicking bacterial surface structures. The platform incorporates four proprietary genetic modifications designed to enhance safety, manufacturing efficiency, and deployment flexibility while preserving the vesicles’ intrinsic immunostimulatory properties.
Its modular plug-and-play design enables rapid incorporation of multiple vaccine antigens, allowing scientists to accelerate vaccine development against newly emerging respiratory pathogens and other infectious diseases. In addition, the platform has demonstrated stability under standard refrigeration conditions for more than 2.5 years, eliminating dependence on ultra-cold storage and improving global distribution capabilities during future public health emergencies.
Clinical Validation Strengthens Pandemic Preparedness Programs
The successful clinical validation significantly strengthens AdJane’s broader development strategy focused on pandemic preparedness, respiratory infectious diseases, and antimicrobial resistance. The company is currently advancing multiple vaccine programs, including collaborations targeting broad-spectrum respiratory viral protection and innovative vaccine candidates designed to combat multidrug-resistant Neisseria gonorrhoeae, one of the world’s most common sexually transmitted bacterial pathogens. As global health organizations continue to prioritize vaccines capable of limiting both infection and transmission, mucosal vaccination technologies are emerging as an increasingly important component of future infectious disease prevention strategies.
AdJane believes its clinically validated nOMV platform provides a scalable foundation for rapidly developing vaccines against emerging pathogens while supporting long-term global preparedness efforts. The publication of these first-in-human Phase I results marks an important milestone for the company and reinforces the growing scientific interest in intranasal vaccines, mucosal immunology, and next-generation vaccine platforms capable of addressing future infectious disease threats through innovative immune protection strategies.
Source: AdJane press release
