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

Not Applicable

• Conditions: Rabies
• Interventions: Biological: rabies vaccine

• Registration Number: NCT02547727
• Lead Sponsor: Queen Saovabha Memorial Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Study Start: 2016-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular vaccination	rabies vaccine	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.
Four-site intradermal vaccination	rabies vaccine	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.

Primary Outcome Measures

Name	Time	Method
Rabies neutralizing antibody titers	Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks	Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute, Thai Red Cross Society; 🇹🇭 Bangkok, Thailand