MMR Vaccination Among HIV-infected Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand

Conditions
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HIV

Intervention / Treatment
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* Biological: 0.5 ml of MMR vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For HIV-infected participants, inclusions criteria were 20-59 years old, ability to provide informed consent receiving cART CD4 cell count ≥200 cell/mm3 within 6 months before enrollment plasma HIV-1 RNA <50 copies/mL, and 5) ability to provide informed consent. Exclusion Criteria: For both groups pregnancy or lactating receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment impaired renal function (creatinine clearance <30 mL/min) impaired liver function as defined by Child-Pugh C.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV-infected adults<br>Two-hundreds and forty-nine HIV-infected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologicals) at deltoid region. Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. | Biological: 0.5 ml of MMR vaccine<br>* Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region<br>|
| Experimental: HIV-uninfected adults<br>Forty-six HIV-uninfected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologic) at deltoid region. Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains. | Biological: 0.5 ml of MMR vaccine<br>* Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with protective antibodies to measles, mumps, and rubella | Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with protective antibodies to measles, mumps, and rubella | 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 | 8-12 weeks after a single dose of MMR vaccination | 
| Proportion of participants with protective antibodies to measles, mumps, and rubella | 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 | 48 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-measles IgG level | 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 | 8-12 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-measles IgG level | 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 | 48 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-mumps IgG titers | 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 | 8-12 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-mumps IgG titers | 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 | 48 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-rubella IgG level | 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 | 8-12 weeks after a single dose of MMR vaccination | 
| The geometric means of anti-rubella IgG level | 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 | 48 weeks after a single dose of MMR vaccination | 
| Proportion of participants who had adverse effects from 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 | 72 hours after MMR vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMR, vaccination, HIV, Serologic response