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

Not Applicable

• Conditions: Rabies
• Interventions: Procedure: Blood drawn after rabies booster vaccination

• Registration Number: NCT03228069
• Lead Sponsor: Queen Saovabha Memorial Institute

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Study Start: 2017-08-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional IM vaccination	Blood drawn after rabies booster vaccination	Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.
single visit 4-site ID vaccination	Blood drawn after rabies booster vaccination	Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.

Primary Outcome Measures

Name	Time	Method
Rabies Neutralizing Antibody Titers (RNab)	GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.	Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)

Secondary Outcome Measures

Name	Time	Method
Rabies specific T cell response	Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.	Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute; 🇹🇭 Bangkok, Thailand