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

Queen Saovabha Memorial Institute

Status: Unknown

Conditions: Rabies

Treatments: Biological: rabies vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02547727

495/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Four-site intradermal vaccination

Experimental group

Description:

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.

Treatment:

Biological: rabies vaccine

Intramuscular vaccination

Active Comparator group

Description:

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.

Treatment:

Biological: rabies vaccine