Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults

NCT ID: NCT03228069

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

2017-08-01

Study Completion Date

2023-12-31

Brief Summary

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To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Detailed Description

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Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

Conditions

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Rabies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single visit 4-site ID vaccination

Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.

Group Type EXPERIMENTAL

Blood drawn after rabies booster vaccination

Intervention Type PROCEDURE

Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Conventional IM vaccination

Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.

Group Type ACTIVE_COMPARATOR

Blood drawn after rabies booster vaccination

Intervention Type PROCEDURE

Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Interventions

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Blood drawn after rabies booster vaccination

Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy HIV-infected adults
* Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

Exclusion Criteria

* Have any active opportunistic infections
* Received blood or blood product within 3 months
* Received anti-malarial drugs
* Received rabies vaccination in a previous year.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Saovabha Memorial Institute

OTHER

Sponsor Role lead

Responsible Party

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Suda Sibunruang

Medical doctor

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, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suda Sibunruang, MD

Role: CONTACT

+66 2 2520161 ext. 125

Terapong Tantawichien, MD

Role: CONTACT

+66 2 2520161 ext. 132

Facility Contacts

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Suda Sibunruang, MD

Role: primary

+66 2 2520161 ext. 125

Terapong Tantawichien, MD

Role: backup

+66 2 2520161 ext. 132

Other Identifiers

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1/2017

Identifier Type: -

Identifier Source: org_study_id

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