Clinical trial NCT02724852: MMR Vaccination Among HIV-infected Adults
Official title: Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: MMR
vaccination
HIV
Serologic response
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 632
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with protective antibodies to measles, mumps, and rubella
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of participants with protective antibodies to measles, mumps, and rubella
timeFrame: 8-12 weeks after a single dose of MMR vaccination
measure: Proportion of participants with protective antibodies to measles, mumps, and rubella
timeFrame: 48 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-measles IgG level
timeFrame: 8-12 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-measles IgG level
timeFrame: 48 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-mumps IgG titers
timeFrame: 8-12 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-mumps IgG titers
timeFrame: 48 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-rubella IgG level
timeFrame: 8-12 weeks after a single dose of MMR vaccination
measure: The geometric means of anti-rubella IgG level
timeFrame: 48 weeks after a single dose of MMR vaccination
measure: Proportion of participants who had adverse effects from vaccination
timeFrame: 72 hours after MMR vaccination
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Chiang Mai University
name: Romanee Chaiwarith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaiwarith R, Praparattanapan J, Nuket K, Kotarathitithum W, Supparatpinyo K. Seroprevalence of antibodies to measles, mumps, and rubella, and serologic responses after vaccination among human immunodeficiency virus (HIV)-1 infected adults in Northern Thailand. BMC Infect Dis. 2016 Apr 30;16:190. doi: 10.1186/s12879-016-1499-x.