Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
Primary Purpose
Human Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Agripal
IDflu9μg
IDflu15μg
Sponsored by
About this trial
This is an interventional prevention trial for Human Influenza
Eligibility Criteria
Inclusion Criteria:
- HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Agripal
IDflu9μg
IDflu15μg
Arm Description
28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of subjects with a post-vaccination titer ≥1:40
GMT ratio of the post-vaccination titer to pre-vaccination titer
Full Information
NCT ID
NCT02398097
First Posted
March 1, 2015
Last Updated
March 24, 2015
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02398097
Brief Title
Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
Official Title
Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Agripal
Arm Type
Active Comparator
Arm Description
28 trivalent subunit inactivated intramuscular vaccine (Agripal) recipients: one vaccine injection administered on Day 0
Arm Title
IDflu9μg
Arm Type
Active Comparator
Arm Description
30 reduced-content intradermal split vaccine (IDflu9μg) recipients: one vaccine injection administered on Day 0
Arm Title
IDflu15μg
Arm Type
Active Comparator
Arm Description
28 standard-content intradermal split vaccine (IDflu15μg) recipients: one vaccine injection administered on Day 0
Intervention Type
Biological
Intervention Name(s)
Agripal
Intervention Description
2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
Intervention Type
Biological
Intervention Name(s)
IDflu9μg
Intervention Description
2011/2012 influenza season reduced-content intradermal split vaccine, single dose
Intervention Type
Biological
Intervention Name(s)
IDflu15μg
Intervention Description
2011/2012 influenza season standard-content intradermal split vaccine, single dose
Primary Outcome Measure Information:
Title
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
Time Frame
Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Secondary Outcome Measure Information:
Title
Percentage of subjects with a post-vaccination titer ≥1:40
Time Frame
Outcome measure was assessed 4 weeks after vaccination
Title
GMT ratio of the post-vaccination titer to pre-vaccination titer
Time Frame
Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Other Pre-specified Outcome Measures:
Title
Frequency and duration of local and systemic adverse events
Description
The diary was made based on the Food and Drug Association (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time Frame
Adverse events were recorded for 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Jin Cheong, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26431466
Citation
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.
Results Reference
derived
Learn more about this trial
Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
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