A Study to Evaluate Safety and Immunogenicity of Haemophilus Influenzae Serotype A Vaccine
NCT Number: NCT06465420
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Haemophilus Influenzae Meningitis|Invasive Haemophilus Influenzae Disease
Interventions: BIOLOGICAL: Haemophilus influenzae type a (Hia) glycoconjugate vaccine
Sponsor: InventVacc Biologicals Inc.
Collaborators: Hia Consortium
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-05-29
Completion Date: 2025-03-31
Locations: Canadian Center for Vaccinology (CCfV), Halifax, Nova Scotia, B3K 6R8, Canada|McGill University Health Centre (MUHC) Vaccine Study Centre, Montreal, Quebec, H9H 4Y6, Canada

Summary:
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.

Primary Outcome Measures: Percentage, intensity, and relationship of adverse events to vaccination, Solicited adverse events (AEs) and unsolicited AEs, serious adverse events (SAEs) and medically attended adverse events (MAAEs), Solicited AEs for 7 days and unsolicited AEs for 28 days after each of two IM doses 28 days apart; SAEs and MAAEs up to 6 months
Secondary Outcome Measures: Immunogenicity, Anti-Hia CPS-specific IgG and serum bactericidal assay (SBA), Measure the levels of anti-Hia capsular polysaccharide 28 days after each of two doses and at 180 days post-second dose (Days 0, 28, 56, and 208).
Other Outcome Measures: Immunogenicity, Measure anti-Hia CPS specific IgA by ELISA in the saliva, 28 days after each of two doses and at 180 days post-second dose (Days 0, 28, 56, and 208)