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Cancer Vaccine

Hia Vaccine for Haemophilus Infections

Phase 1
Recruiting
Led By Brian Ward, MD
Research Sponsored by InventVacc Biologicals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects must be between 18 and 40 years of age at the Vaccination visit (Day 0)
Be between 18 and 65 years old
Must not have
Subjects who have received blood-derived products or a blood transfusion within 90 days prior to study vaccination
Presence of any febrile illness (including an oral temperature [OT] ≥ 38.0 ˚C within 24 hours prior to vaccination)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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

Summary

"This trial aims to develop a vaccine to protect Indigenous children in Canada and Alaska from Haemophilus influenzae serotype a (Hia), a serious illness. The vaccine uses a protein carrier to

Who is the study for?
This trial is for healthy adults in the general population. It's focused on preventing serious illness caused by Haemophilus influenzae serotype a (Hia), which has been affecting Indigenous children in Canada and Alaska.
What is being tested?
The study tests the safety and ability to provoke an immune response of a new Hia glycoconjugate vaccine using protein carrier CRM197. This first-in-human study will take place at two Canadian research centers.
What are the potential side effects?
As this is an initial human trial, specific side effects are not yet known but may include typical vaccine reactions such as pain at injection site, fever, fatigue, headache, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received blood products or a transfusion in the last 3 months.
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I have not had a fever or any illness with a fever of 38.0˚C or higher in the last 24 hours.
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I have a history of neurological disorders or seizures.
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I have had serious asthma issues or hospital visits for it in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage, intensity, and relationship of adverse events to vaccination
Other study objectives
Immunogenicity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vaccine armActive Control1 Intervention
This arm receives 0.5 mL of a 10 µg dose of Hia Conjugate Vaccine with AdjuPhos.
Group II: Placebo armPlacebo Group1 Intervention
This arm receives 0.5 mL placebo (normal saline).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hia ConsortiumUNKNOWN
InventVacc Biologicals Inc.Lead Sponsor
Brian Ward, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
5 Previous Clinical Trials
32,485 Total Patients Enrolled
~9 spots leftby Dec 2024
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