MMR Vaccination Among HIV-infected Adults

Chiang Mai University

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Biological: 0.5 ml of MMR vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02724852

Research ID: 268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 632 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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632 participants in 2 patient groups

HIV-infected adults

Active Comparator group

Description:

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.

Treatment:

Biological: 0.5 ml of MMR vaccine

HIV-uninfected adults

Experimental group

Description:

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.

Treatment:

Biological: 0.5 ml of MMR vaccine