HIV
Conditions
Keywords
MMR, vaccination, HIV, Serologic response
Brief summary
This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses.
Detailed description
From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the eligibility criteria were enrolled and tested for protective antibodies to measles, mumps, and rubella. All participants who had no protective antibody to at least one of the three viruses were recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and 46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and week 48 after vaccination, which were completed in August 2013. The results were ready for analysis in March 2014.
Interventions
BIOLOGICAL0.5 ml of MMR vaccine
Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
Sponsors
Chiang Mai University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
For HIV-infected participants, inclusions criteria were 1. 20-59 years old, ability to provide informed consent 2. receiving cART 3. CD4 cell count ≥200 cell/mm3 within 6 months before enrollment 4. plasma HIV-1 RNA \<50 copies/mL, and 5) ability to provide informed consent.
Exclusion criteria
For both groups 1. pregnancy or lactating 2. receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment 3. impaired renal function (creatinine clearance \<30 mL/min) 4. impaired liver function as defined by Child-Pugh C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with protective antibodies to measles, mumps, and rubella | Baseline | Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with protective antibodies to measles, mumps, and rubella | 8-12 weeks after a single dose of MMR vaccination | Comparison of proportion of participants who had protective antibodies to measles, mumps, and rubella between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses |
| The geometric means of anti-measles IgG level | 8-12 weeks after a single dose of MMR vaccination | Comparison of the geometric means of anti-measles IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses |
| The geometric means of anti-mumps IgG titers | 8-12 weeks after a single dose of MMR vaccination | Comparison of the geometric means of anti-mumps IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses |
| The geometric means of anti-rubella IgG level | 8-12 weeks after a single dose of MMR vaccination | Comparison of the geometric means of anti-rubella IgG level between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses |
| Proportion of participants who had adverse effects from vaccination | 72 hours after MMR vaccination | Comparison of proportion of participants who had adverse effects from MMR vaccination between HIV-infected participants and HIV-uninfected participants in those without protective antibody to at least one of the three viruses |
Countries
Thailand
Outcome results
None listed