MMR Vaccination Among HIV-infected Adults

Chiang Mai University632 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

632

Conditions

HIV

Interventions

0.5 ml of MMR vaccineBIOLOGICAL

Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region

Eligibility

Sex: ALLMin age: 20 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Muang, Chiang Mai, Thailand

Outcomes

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

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

Time frame: 8-12 weeks after a single dose of MMR vaccination

Proportion of participants with protective antibodies to measles, mumps, and rubella

Time frame: 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

Time frame: 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

Time frame: 48 weeks after a single dose of MMR vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.