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

Rabies Clinical Trial

Official title:

Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228069
• Other study ID #: 1/2017
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Queen Saovabha Memorial Institute
• Contact: Suda Sibunruang, MD
• Phone: +66 2 2520161
• Email: sudapunrin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rabies

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Thailand	Queen Saovabha Memorial Institute	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rabies specific regulatory T cells	Rabies specific regulatory T cells is measured by flow cytometry method	Numbers of Rabies specific regulatory T cells 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.
Primary	Rabies Neutralizing Antibody Titers (RNab)	Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)	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.
Secondary	Rabies specific T cell response	Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)	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.