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MMR Vaccination Among HIV-infected Adults

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ClinicalTrials.gov Identifier: NCT02724852
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Biological: 0.5 ml of MMR vaccine Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV-infected adults

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
Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
Experimental: HIV-uninfected adults

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724852


Locations
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Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Romanee Chaiwarith, MD Chiang Mai University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02724852    
Other Study ID Numbers: Research ID: 268
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Romanee Chaiwarith, Chiang Mai University:
MMR
vaccination
HIV
Serologic response