Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

NCT02398097 | Completed Phase 4 DMC

• 1 other identifier: FLUHIV
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.

Conditions

Human Influenza

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10

  Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)

Secondary Outcomes (2)

• Percentage of subjects with a post-vaccination titer ≥1:40

  Outcome measure was assessed 4 weeks after vaccination

• GMT ratio of the post-vaccination titer to pre-vaccination titer

  Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)

Other Outcomes (1)

• Frequency and duration of local and systemic adverse events

  Adverse events were recorded for 7 days.

Study Arms (3)

Agripal

ACTIVE COMPARATOR

28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0

Biological: Agripal

IDflu9μg

ACTIVE COMPARATOR

30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0

Biological: IDflu9μg

IDflu15μg

ACTIVE COMPARATOR

28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0

Biological: IDflu15μg

Interventions

Agripal BIOLOGICAL

2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose

Agripal

IDflu9μg BIOLOGICAL

2011/2012 influenza season reduced-content intradermal split vaccine, single dose

IDflu9μg

IDflu15μg BIOLOGICAL

2011/2012 influenza season standard-content intradermal split vaccine, single dose

IDflu15μg

Eligibility Criteria

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

You may qualify if:

• HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine

You may not qualify if:

• known allergy to egg
• presentation of any febrile illness ≥37.5°C on the day of vaccination
• any history of hypersensitivity reaction to previous influenza vaccination
• any other vaccinations within the past one month
• use of immunosuppressive agent
• recipient of blood product or immunoglobulins during the previous three months
• any other conditions that might interfere with the study results

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Related Publications (1)

• Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599.

  PMID: 26431466 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Hee Jin Cheong, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 25, 2015
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 25, 2015

Record last verified: 2015-03