Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults

Study Overview
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Brief Summary
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A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.

Detailed Description
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A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.

Official Title
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Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Conditions
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Rabies

Intervention / Treatment
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* Biological: rabies vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected patients Age 18 - 60 years Received primary rabies immunization Exclusion Criteria: Have any active opportunistic infections Received blood or blood product within 3 months Allergy to vaccine or any vaccine components Received anti-malarial drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Four-site intradermal vaccination<br>0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. | Biological: rabies vaccine<br>* Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.<br>|
| Active Comparator: Intramuscular vaccination<br>0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. | Biological: rabies vaccine<br>* Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies neutralizing antibody titers | Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs) | Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific T cell response | Specific T cell response is measured by OX-40 assay | Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks | 
| Cytokines assessment | A few cytokines levels are measured by multiplex bead array assay | Change from baseline of cytokines levels at 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies vaccination