Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons

NCT00996970

Influenza HIV Infections

COMPLETED

Immune Response to Influenza Vaccine in HIV-Infected Individuals

NCT00069914

HIV Infections

COMPLETED

Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults

NCT01155037

HIV Infection

COMPLETED PHASE2

Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

NCT01381029

Influenza, Human Human Immunodeficiency Virus I Infection

COMPLETED

Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load

NCT00025922

HIV Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Agripal

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

Group Type ACTIVE_COMPARATOR

Agripal

Intervention Type BIOLOGICAL

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

IDflu9μg

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

Group Type ACTIVE_COMPARATOR

IDflu9μg

Intervention Type BIOLOGICAL

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

IDflu15μg

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

Group Type ACTIVE_COMPARATOR

IDflu15μg

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Agripal

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

Intervention Type BIOLOGICAL

IDflu9μg

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

Intervention Type BIOLOGICAL

IDflu15μg

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No