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Completed

NCT Number: NCT02724852

MMR Vaccination Among HIV-infected Adults

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.

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Key information

Conditions

HIV

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Muang, Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.5 ml of MMR vaccine

Biological

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

Primary outcomes

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

    Time frame: Baseline

    Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants

Secondary outcomes

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

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

    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

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

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

    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

  3. The geometric means of anti-measles IgG level

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

    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

  4. The geometric means of anti-measles IgG level

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

    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

  5. The geometric means of anti-mumps IgG titers

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

    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

  6. The geometric means of anti-mumps IgG titers

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

    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

  7. The geometric means of anti-rubella IgG level

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

    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. The geometric means of anti-rubella IgG level

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

    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

  9. Proportion of participants who had adverse effects from vaccination

    Time frame: 72 hours after MMR 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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 31, 2016
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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