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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02398097
Other study ID # FLUHIV
Secondary ID
Status Completed
Phase Phase 4
First received March 1, 2015
Last updated March 24, 2015
Start date November 2011
Est. completion date April 2012

Study information

Verified date March 2015
Source Korea University Guro Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date April 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Agripal
2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
IDflu9µg
2011/2012 influenza season reduced-content intradermal split vaccine, single dose
IDflu15µg
2011/2012 influenza season standard-content intradermal split vaccine, single dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Korea University Guro Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Frequency and duration of local and systemic adverse events 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 Adverse events were recorded for 7 days. Yes
Primary 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) No
Secondary Percentage of subjects with a post-vaccination titer =1:40 Outcome measure was assessed 4 weeks after vaccination No
Secondary GMT ratio of the post-vaccination titer to pre-vaccination titer Outcome measure was assessed at two points (baseline and 4 weeks after vaccination) No
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