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To study immunological tolerance effect after frequent rabies booster vaccination
Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Persons who had received primary immunization |
|
| Study group | Experimental | Persons who had received primary immunization and later received booster vaccination for at least 3 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood drawn after rabies vaccine booster vaccination | Biological | All participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies specific regulatory T cells | Rabies specific regulatory T cells are measured by flow cytometry method | Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms |
| Rabies specific regulatory B cells | Rabies specific regulatory B cells are measured by flow cytometry method | Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms |
| Rabies specific T follicular helper cells | Rabies specific T follicular helper cells are measured by flow cytometry method | Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies Neutralizing Antibody Titers (RNab) | Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs) | before (baseline) and one month after receipt of rabies booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines | Cytokines i.e., IL-10, TGF-Beta are measured by ELISA | Change from baseline of quantitative measurement of cytokines levels would be measured before (baseline) and one month after receipt of rabies booster vaccination and compared between 2 arms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suda Sibunruang, MD | Contact | +66 2 2520161 | 125 | sudapunrin@gmail.com |
| Terapong Tantawichien, MD | Contact | +66 2 2520161 | 125 | terapong_tantawichien@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suda Sibunruang, MD | Queen Saovabha Memorial Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Saovabha Memorial Institute | Recruiting | Pathum Wan | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group.
All participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.
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The serum samples from all participants would be labelled as the codes, of which the laboratory technicians could not access to the groups or other details of the participants.
|
| D007239 | Infections |