Influenza Vaccine in HIV

NCT00764998 | Completed Phase 3

• 1 other identifier: CTN237
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 13

Brief Summary

The purposes of this research study are:

1. 1.to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine
2. 2.to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce laboratory documented influenza in HIV Infected adults.

Conditions

Influenza; HIV

Keywords

Influenza; HIV; Influenza Vaccine; Efficacy

Outcome Measures

Primary Outcomes (1)

• Immunogenicity measured by haemagglutination inhibition (HI)

  baseline, week 4, week 8 and week 20.

Secondary Outcomes (1)

• Frequencies of laboratory confirmed influenza and Frequencies clinical/respiratory illness

  event driven

Study Arms (2)

Fluviral

ACTIVE COMPARATOR

Biological: Fluviral

placebo

PLACEBO COMPARATOR

Biological: Fluviral

Interventions

Fluviral BIOLOGICAL

Also known as: non applicable

Fluviral; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - \< 60 years
• HIV positive
• Able to provide signed, informed consent.

You may not qualify if:

• Receipt or anticipated requirement of any blood product, vaccine, or immunoglobulin preparation within one month of study vaccine administration until completion of study.
• Immunosuppressive therapy including prednisone, immune modulators, subjects undergoing dialysis, autoimmune dysfunction (including rheumatoid arthritis, lupus erythematosus, multiple sclerosis)
• Alcohol consumption \> 4 drinks per day (1 drink is equal to a 12-ounce can of beer, or a 5-ounce glass of wine or one cocktail with 1 1/2-ounces alcohol)
• History of cancer, with the exception of cutaneous cancers including Kaposi Sarcoma, basal cell carcinoma and non-invasive HPV-related malignancy
• Known or suspected hypersensitivity to any component of the study vaccines, including chicken eggs or egg products and thimerosol
• History of immediate hypersensitivity reaction and/or reaction resulting in neurological symptoms to a previous dose of any influenza vaccine
• Presentation with or any recent history (within 24 hours) of any febrile illness (\> 38 C) or symptoms of significant local or systemic infection - such subjects will be deferred from enrollment at least until one week after the illness has resolved
• Any other condition which in the opinion of the Investigator might interfere with evaluation of the study objectives.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ontario HIV Treatment Network: collaborator
• Public Health Agency of Canada (PHAC): collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (13)

Southern Alberta Clinic

Calgary, Alberta, T2R 0X7, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

BC Center for Excellence in HIV/Aids

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Downtown Immunodeficiency Clinic / UBC

Vancouver, British Columbia, V6Z 2C7, Canada

Location

QEII HSC, Victoria General Hospital Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

McMaster University Medical Center

Hamilton, Ontario, L8N 4A6, Canada

Location

Infectious Disease Care Program

London, Ontario, N5Y 3H6, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

University of Ottawa Health Services

Toronto, Ontario, K1N 6N5, Canada

Location

Sunnybrook Health Science Center

Toronto, Ontario, M2N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

HIV Care Program - Windsor Regional Hospital

Windsor, Ontario, N8W 1E3, Canada

Location

Immunodeficiency Service, Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (2)

• Cooper C, Thorne A, Klein M, Conway B, Boivin G, Haase D, Shafran S, Zubyk W, Singer J, Halperin S, Walmsley S; CIHR Canadian HIV Trials Network Influenza Vaccine Research Group. Immunogenicity is not improved by increased antigen dose or booster dosing of seasonal influenza vaccine in a randomized trial of HIV infected adults. PLoS One. 2011 Mar 25;6(3):e17758. doi: 10.1371/journal.pone.0017758.

  PMID: 21512577 RESULT

• Nosyk B, Sharif B, Sun H, Cooper C, Anis AH; CIHR Canadian HIV Trials Network Influenza Vaccine Research Group. The cost-effectiveness and value of information of three influenza vaccination dosing strategies for individuals with human immunodeficiency virus. PLoS One. 2011;6(12):e27059. doi: 10.1371/journal.pone.0027059. Epub 2011 Dec 6.

  PMID: 22162988 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Curtis Cooper, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

CA (13)