A Study to Evaluate Safety and Immunogenicity of Haemophilus Influenzae Serotype A Vaccine

Haemophilus influenzae serotype a (Hia) has emerged as a leading cause of serious illness in Indigenous children in Canada and Alaska in recent decades. In hospital-based surveillance studies, Hia was the most common cause of invasive disease, resulting in morbidity or mortality after Haemophilus influenzae serotype b (Hib). Given the success of the Hib vaccine program and the pathophysiologic similarities between Hib and Hia, immunization is the obvious way to protect Indigenous children living in small and scattered communities. The Public Health Agency of Canada has been working with the National Research Council and other members of the Consortium, including the Canadian Immunization Research Network, McGill Interdisciplinary Initiative in Infection and Immunity, GlycoNet, the Hewitt Foundation, and Inventprise/InventVacc, to develop a Hia vaccine for prevention of this deadly infection. The engagement process initiated by NRC with Consortium members and representatives from Indigenous groups, particularly, has led to the current project plan. In this first-in-human study, the investigators propose investigating the safety and immunogenicity of a novel glycoconjugate candidate vaccine that uses protein carrier CRM197 in healthy adults in the general population. The study will be conducted at the McGill University Health Center Vaccine Study Centre in Montreal and the Canadian Center for Vaccinology in Halifax. The findings of this Phase I study will be necessary to effectively move this potential vaccine solution further along the development continuum.

NCT Number	NCT06465420
Lead Sponsor	InventVacc Biologicals Inc. Collaborators: Hia Consortium
Conditions	Haemophilus Influenzae Meningitis, Invasive Haemophilus Influenzae Disease
Enrollment	30 participants
Start Date	2024-05-29
Primary Completion	2024-10-15 (estimated)
Study Completion	2025-09-15 (estimated)
Updated on ClinicalTrials.gov	2025-04-30