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 weeks3 visits

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

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.