Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Human Influenza Clinical Trial

Official title:

Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398097
• Other study ID #: FLUHIV
• 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

• Human Influenza
• Influenza, Human

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