HIV, Rabies
Conditions
Keywords
HIV, booster, rabies, immune response
Brief summary
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
Detailed description
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.
Interventions
BIOLOGICALrabies 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 0,7,14,30,90,180,360
Sponsors
Queen Saovabha Memorial Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV infected patients 18-60 years of age * Ever received primary rabies immunization
Exclusion criteria
* currently have any active opportunistic infections * have received blood or blood product within previous 3 months * history of allergy to vaccine or any vaccine components * currently received anti-malarial drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rabies Neutralizing Antibody Titers | Day 360 | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Rabies Vaccines on Day 0 and 3 |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 7.8 |
| CD4+ T lymphocyte counts | 489 cell/mm^3 |
| Region of Enrollment Thailand | 33 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: Day 360
Population: As preliminary study, the number of participants was estimated to be above 15 - 20 cases.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rabies Vaccines on Day 0 and 3 | Rabies Neutralizing Antibody Titers | 8.48 IU/ml |