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Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

NCT ID: NCT01286493

Last Updated: 2015-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

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Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

Detailed Description

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The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

Conditions

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HIV Rabies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rabies vaccines on day 0 and 3

Cell culture Rabies vaccines on day 0 and 3

Group Type EXPERIMENTAL

rabies vaccines on day 0 and 3

Intervention Type BIOLOGICAL

All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360

Interventions

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rabies vaccines on day 0 and 3

All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* HIV infected patients 18-60 years of age
* Ever received primary rabies immunization

Exclusion Criteria

* currently have any active opportunistic infections
* have received blood or blood product within previous 3 months
* history of allergy to vaccine or any vaccine components
* currently received anti-malarial drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Saovabha Memorial Institute

OTHER

Sponsor Role lead

Responsible Party

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Suda Sibunruang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suda Sibunruang, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Saovabha Memorial Institute

Locations

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Queen Saovabha Memorial Institute

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.saovabha.com

http://www.saovabha.com/th/academic.asp

Other Identifiers

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RC5303

Identifier Type: -

Identifier Source: org_study_id