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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02547727
Enrollment
40
Registered
2015-09-11
Start date
2016-02-29
Completion date
2023-12-31
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Keywords

rabies vaccination

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.

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.

Interventions

BIOLOGICALrabies 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.

Sponsors

Chulalongkorn University
CollaboratorOTHER
Queen Saovabha Memorial Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rabies neutralizing antibody titersChange from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeksRabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)

Secondary

MeasureTime frameDescription
Specific T cell responseChange from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeksSpecific T cell response is measured by OX-40 assay
Cytokines assessmentChange from baseline of cytokines levels at 1 weekA few cytokines levels are measured by multiplex bead array assay

Countries

Thailand

Contacts

Primary ContactSuda Sibunruang, MD
sudapunrin@gmail.com+66 81 7366076
Backup ContactTerapong Tantawichien, MD
terapong_tantawichien@hotmail.com+66 81 7350654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026