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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03228069
Enrollment
40
Registered
2017-07-24
Start date
2017-08-01
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

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 .

Interventions

PROCEDUREBlood 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.

Sponsors

Queen Saovabha Memorial Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Rabies specific T cell responseNumbers 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)

Other

MeasureTime frameDescription
Rabies specific regulatory T cellsNumbers 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.Rabies specific regulatory T cells is measured by flow cytometry method

Countries

Thailand

Contacts

Primary ContactSuda Sibunruang, MD
sudapunrin@gmail.com+66 2 2520161
Backup ContactTerapong Tantawichien, MD
terapong_tantawichien@hotmail.com+66 2 2520161

Outcome results

None listed

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