AdJane's Intranasal nOMV Vaccine Platform Shows First Human Proof-of-Concept for Mucosal Immunity
核心洞察
AdJane (搜索) published first-in-human Phase I data in Vaccines showing its intranasal native outer membrane vesicle platform induced both mucosal and systemic immune responses in 40 healthy adults.
The randomized, double-blind, placebo- and OMV-controlled trial combined the platform with a SARS-CoV-2 Spike protein (搜索) and produced dose-dependent neutralizing antibody responses.
A post-hoc subset of participants previously primed with Pfizer or Moderna mRNA vaccines developed significant nasal IgA after intranasal Nm-nOMV boosting.
AdJane (搜索) has reported the first clinical validation of its native Outer Membrane Vesicle (nOMV) vaccine platform, publishing first-in-human Phase I data in the peer-reviewed journal Vaccines that demonstrate the ability of the intranasally administered technology to induce both mucosal and systemic immune responses in humans.
The first-in-human, randomized, double-blind, placebo- and OMV-controlled trial enrolled 40 healthy SARS-CoV-2 (搜索) seropositive adults aged 18–55 years. AdJane (搜索)'s platform, combined with a SARS-CoV-2 Spike protein (搜索) and delivered intranasally, was safe and well tolerated and triggered dose-dependent systemic immune responses across multiple measures, including virus-neutralizing antibodies. Critically, the study showed induction of immune activity at the nasal mucosa — the primary entry site for many respiratory pathogens. The trial is registered at ClinicalTrials.gov under identifier NCT05604690.
"This publication represents an important validation milestone for AdJane (搜索) 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
The COVID-19 (搜索) pandemic highlighted a persistent challenge in infectious disease control: while injectable vaccines 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. According to AdJane (搜索), 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 grows globally, mucosal vaccination is increasingly recognized as an emerging modality in vaccine development. AdJane (搜索) states that its nOMV platform is designed to support rapid adaptation against emerging respiratory pathogens while enabling scalable and practical deployment.
Platform Design and Manufacturing
AdJane (搜索)'s nOMV platform is based on more than three decades of scientific research originating from leading Dutch governmental research institutions. It utilizes native outer membrane vesicles derived from Neisseria meningitidis (搜索) bacteria, which naturally stimulate the immune system while closely mimicking bacterial surface structures.
The platform incorporates four proprietary genetic modifications intended to improve safety, manufacturing performance, and deployment flexibility while preserving the intrinsic immunostimulatory properties of the vesicles. It is designed as a modular plug-and-play technology that enables incorporation of multiple antigens through several engineering approaches, supporting rapid vaccine development against newly emerging pathogens and other infectious disease targets. AdJane (搜索) reports that the platform has demonstrated stability under standard refrigeration conditions for more than 2.5 years, supporting stockpiling and broader global deployment without reliance on ultra-cold supply chains.
Mucosal Booster Strategy for Established Vaccine Franchises
In a September 2026 White Paper titled Boosting mRNA: Mucosal Immunity and a Platform Beyond It, AdJane (搜索) outlined a potential new application of its Neisseria meningitidis (搜索) nOMV (Nm-nOMV) platform: adding mucosal boosting to established intramuscular respiratory vaccine franchises.
The strategy builds on systemic immunity established by intramuscular priming with an intranasal Nm-nOMV booster designed to induce complementary immunity at the respiratory mucosa. In this heterologous prime-boost approach, vaccine developers could retain the benefits, infrastructure, and broad coverage of established respiratory vaccines while developing next-generation regimens that add a proprietary mucosal component. AdJane (搜索) notes there is a growing body of evidence that mucosal IgA responses can reduce transmission at the point of entry.
"Respiratory vaccine innovation can start from what already works: vaccines that protect millions of people," said Anita Gashi, CEO of AdJane (搜索). "By adding an intranasal Nm-nOMV booster to established intramuscular vaccines, we aim to induce complementary immunity at the site of infection and enable next-generation vaccination regimens with a proprietary mucosal component."
Initial clinical support for the booster concept comes from a post-hoc identified subset of Phase I participants who had previously received Pfizer and/or Moderna COVID-19 (搜索) mRNA vaccines. In these individuals, subsequent intranasal administration of an Nm-nOMV vaccine displaying SARS-CoV-2 (搜索) Spike was well tolerated and induced significant nasal IgA responses. AdJane (搜索) states that further clinical studies will be required to establish the magnitude, durability, and potential clinical relevance of the additional mucosal immune response. While the initial observations relate to individuals previously primed with COVID-19 mRNA vaccines, the company notes that limited mucosal immunity is not unique to mRNA vaccination and is a feature of many intramuscular respiratory vaccination strategies.
Subject to further development and clinical validation, potential applications could extend across COVID-19 (搜索), influenza (搜索), RSV (搜索), combination respiratory vaccines, and future pandemic preparedness. AdJane (搜索) has developed an intellectual property portfolio around its Nm-nOMV platform covering the platform, manufacturing, mucosal dosing, and specific vaccine applications, and has filed separate patent applications covering combinations of OMV technology with mRNA vaccines and respiratory vaccines.
Broader Development Programs
AdJane (搜索) is applying the platform across multiple programs beyond respiratory viruses. These include pandemic preparedness collaborations targeting broad-spectrum respiratory viral protection in partnership with CEPI, and antimicrobial resistance applications including a CARB-X (搜索)-supported program against multidrug-resistant Neisseria gonorrhoeae (搜索) — described by the company as one of the most commonly reported sexually transmitted bacterial infections, responsible for over 80 million new infections annually.
AdJane (搜索) is a clinical-stage vaccine platform company developing next-generation intranasal and intramuscular vaccines based on its nOMV technology, with a focus on pandemic preparedness, antimicrobial resistance, and global infectious disease challenges. The company states that its platform supports multiple deployment modalities for both prophylactic and therapeutic applications.