H5N1 Vaccine for Avian Flu

Recruiting at 3 trial locations

Overseen By CIRN-Clinical Trials Network

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Canadian Immunization Research Network

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

312 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Given the recent circulation of avian influenza A(H5N1) clade 2.3.4.4b strains in birds and mammals in North America, Canada procured a supply of Arepanrix™ H5N1 for potential use in persons at high risk of highly pathogenic avian influenza exposure.

This vaccine received regulatory approval in 2013, to be given in two doses at least 3 weeks apart. There is limited data on the effect of various intervals between the two doses on immunogenicity and tolerability. In this study two intervals between doses will be compared (3 vs. 8 weeks apart).

Who Is on the Research Team?

Joanne M Langley

Principal Investigator

CIRN, Canadian Center for Vaccinology, Dalhousie University

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of exposure to the highly pathogenic avian influenza A(H5N1). Participants must meet certain health criteria, but specific inclusion and exclusion details are not provided here.

Inclusion Criteria

Able to comply with the trial procedures

Informed consent signed prior to trial-specific procedures

If a person is at risk of becoming pregnant, has practiced adequate contraception for 28 days prior to visit 1, has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception until 60 days after the final vaccination

Exclusion Criteria

Receipt of avian influenza A(H5N1) vaccine anytime

I haven't taken immunosuppressants in the last 6 months, except for short-term or topical steroids.

I haven't had a fever or serious illness in the last 24 hours.

What Are the Treatments Tested in This Trial?

Interventions

• H5N1 vaccine (Arepanrix)

Trial Overview The study tests the immunogenicity and safety of two doses of Arepanrix™ H5N1 vaccine given either 3 or 8 weeks apart. The goal is to determine which dosing interval is more effective.

How Is the Trial Designed?

Group I: Group 2: H5N1 vaccines administered 8 weeks apart Active Control 2 Interventions

Two doses of the H5N1 vaccine administered 8 weeks apart Normal saline will be administered as a placebo at week 3.

Group II: Group 1: H5N1 vaccines administered 3 weeks apart Active Control 2 Interventions

Two doses of the H5N1 vaccine administered 3 weeks apart. Normal saline will be administered as a placebo at week 8.

Who Is Running the Clinical Trial?

Canadian Immunization Research Network

Lead Sponsor

Trials

12

Recruited

10,600+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Canadian Center for Vaccinology

Collaborator

Trials

12

Recruited

6,300+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Vaccine Evaluation Center, Canada

Collaborator

Trials

3

Recruited

340+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+