Dutch manufacturer Intravacc has announced it has been awarded a contract that may total US$14.6 million from the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the development of a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG).
Gonorrhea is a sexually transmitted disease caused by the NG bacteria. Intravacc will develop a prophylactic vaccine based on its proprietary outer membrane vesicles (OMV) platform technology.
The NG vaccine, called NGoXIM, is based on gonococcal OMVs combined with sustained-release microspheres containing recombinant human IL-12, and will be administered intranasally. Proof-of-concept studies with NGoXIM have already shown the vaccine to be effective in animal models, inducing a potent, lasting, and cross-protective immune response. Intravacc will develop a complete production process for NGoXIM to generate vaccine batches under Good Manufacturing Practices.
The company will work towards a non-clinical toxicity (TOX) and Clinical Trial Material batch to execute a Phase I study in healthy adults, investigating the safety of the vaccine and generating efficacy data. The IL-12 containing microspheres called GneX12 will be developed and produced by Therapyx Inc.
Gonorrhoea is the second most common bacterial infectious disease in the US, with a reported incidence of more than 300,000 cases per year. Due to under-reporting and an asymptomatic disease course, the true incidence is believed to be more than double the reported incidence. NG, a gram-negative aerobic 0.6–1.0 µm bacteria, is the cause of this sexually transmitted disease.
Currently there is no effective gonorrhoea vaccine available, and the disease is known to be contracted repeatedly without apparently developing protective immunity. In addition, antibiotic resistance is increasingly common for this bacterium. Gonorrhoea is on the WHO high-priority list of antimicrobial resistant bacteria.
The project is funded by Federal funds from the National Institute of Allergy & Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93022C00058.
Dr Jan Groen, Intravacc’s CEO, said: “Together with our subcontractor Therapyx, we are honoured that NIH and NIAID have awarded us this contract, allowing both of us to demonstrate the safety and tolerability of our intranasal gonorrhoea vaccine candidate, NGoXIM (Avacc 11).”