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Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabies vaccines on day 0 and 3 | Experimental | Cell culture Rabies vaccines on day 0 and 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabies vaccines on day 0 and 3 | Biological | All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360 |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies Neutralizing Antibody Titers | Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year. | Day 360 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suda Sibunruang, MD | Queen Saovabha Memorial Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Saovabha Memorial Institute | Bangkok | Bangkok | 10330 | Thailand |
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| Label | URL |
|---|---|
| http://www.saovabha.com/th/academic.asp | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabies Vaccines on Day 0 and 3 | Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Preliminary study
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabies Vaccines on Day 0 and 3 | Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rabies Neutralizing Antibody Titers | Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year. | As preliminary study, the number of participants was estimated to be above 15 - 20 cases. | Posted | Geometric Mean | Full Range | IU/ml | Day 360 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rabies Vaccines on Day 0 and 3 | Cell culture Rabies vaccines on day 0 and 3 rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360 |
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Small sample size heterogeneous characteristics of participants Use only CD4+ T lymphocyte counts as the only immunologic surrogate marker
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Suda Sibunruang | Queen Saovabha Memorial Institute | +66 2 2520161 | 125 | sudapunrin@gmail.com |
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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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4+ T lymphocyte counts | Median | Full Range | cell/mm^3 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
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| D007239 | Infections |