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

NCT ID: NCT02547727

Last Updated: 2022-04-29

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2023-12-31

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.

Conditions

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Rabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Four-site intradermal vaccination

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.

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

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.

Intramuscular vaccination

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.

Group Type ACTIVE_COMPARATOR

rabies vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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rabies vaccine

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.

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role collaborator

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. Faculty of Medicine, Chulalongkorn university

Locations

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Queen Saovabha Memorial Institute, Thai Red Cross Society

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suda Sibunruang, MD

Role: CONTACT

+66 81 7366076

Terapong Tantawichien, MD

Role: CONTACT

+66 81 7350654

Facility Contacts

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Suda Sibunruang, M.D.

Role: primary

+66 81 7366076

Terapong Tantawichien, M.D.

Role: backup

+66 2 2520161 ext. 125

Other Identifiers

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495/2015

Identifier Type: -

Identifier Source: org_study_id

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