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

Sponsor

Queen Saovabha Memorial Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT02547727

Collaborator

Chulalongkorn University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rabies	Biological: rabies vaccine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: 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.
Active Comparator: 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.	Biological: 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.

Arm

Intervention/Treatment

Experimental: 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.

Biological: 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.

Active Comparator: 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.

Biological: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Saovabha Memorial Institute, Thai Red Cross Society	Bangkok		Thailand	10330

Sponsors and Collaborators

Queen Saovabha Memorial Institute
Chulalongkorn University

Investigators

Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute

ClinicalTrials.gov Identifier:

NCT02547727

Other Study ID Numbers:

495/2015

First Posted:

Sep 11, 2015

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Keywords provided by Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute

rabies vaccination

Additional relevant MeSH terms:

Rabies

Study Results

No Results Posted as of Apr 29, 2022