A Phase 4 interventional study of 0.5 ml of MMR vaccine in HIV, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Chiang Mai University · Phase 4, Interventional, and Prevention
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.
Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For HIV-infected participants, inclusions criteria were
Exclusion Criteria:
For both groups
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
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
Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
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
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
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: 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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 72 hours after MMR vaccination
Plan to share: No
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chiang Mai University