A Study to Evaluate Safety and Immunogenicity of Haemophilus Influenzae Serotype A Vaccine (NCT06465420) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate Safety and Immunogenicity of Haemophilus Influenzae Serotype A Vaccine
Canada30 participantsStarted 2024-05-29
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. The subject must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; the subject must agree to complete study-related procedures and communicate with the study staff at visits and by phone during the study;
✓. To be enrolled, subjects must have a body mass index (BMI) ≤ 32 kg/m2 (https://www.cdc.gov/healthyweight/bmi/calculator.html).
✓. The subject is considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
✓. Male and female subjects must be between 18 and 40 years of age at the Vaccination visit (Day 0);
✓. Subjects must be in stable health and with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or Sub-Investigator (thereafter referred to as Investigator) and determined by medical history, physical examination, and vital signs; Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination.
✓. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening and Vaccination visits (Day 0 \& 28), and Day 56 and must not be lactating. Non-childbearing females are defined as:
What they're measuring
1
Percentage, intensity, and relationship of adverse events to vaccination
Timeframe: 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
✓. Female subjects of childbearing potential and who are sexually active must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, female subjects must have no plan to become pregnant for at least two months post-vaccination. Abstinent subjects who are ovulating should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
✓. The overall similarity of the Hia candidate vaccine to Hib vaccines widely administered in multiple doses to infants for several decades and the absence of genotoxicity in the toxicity study provides further reassurance that a contraceptive requirement in males is not needed.
Exclusion criteria
✕. According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. "Evolving" is defined as:
✕. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse that would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the subject has been otherwise opioid-free for at least three years);
✕. A history of neurologic disorders or seizures;
✕. Any history of autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, type 1 diabetes, and inflammatory bowel disease) or any confirmed or suspected congenital or acquired immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), hepatitis B or C infection, the presence of lymphoproliferative disease, tested for at the screening. Very little investigator discretion will be permitted with this exclusion criterion but rare subjects may still be eligible to participate with appropriate written justification in the source document (e.g., documented HBV carrier status with no evidence of active liver disease, cured HCV with documented clearance of virus, very mild psoriasis \[i.e., a small number of minor plaques requiring no treatment\], etc.);
✕. Any hematologic or biochemical laboratory abnormalities, as defined by lab normal ranges. To exclude transient abnormalities, the Investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. Grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the Investigator.
✕. Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
✕. Administration or planned administration of any vaccine (including routine vaccines) within 30 days prior to Hia immunization and up to 30 days post-second dose of vaccine. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
✕. Administration of any adjuvanted, "standard" influenza non-adjuvanted (e.g., live attenuated inactivated vaccine or split inactivated vaccine administered by intranasal, intradermal, or intramuscular \[IM\] route) or investigational vaccine within 30 days prior to randomization, administration prior to the completion of the study and up to 30 days post-second dose of vaccine;