MMR Vaccination Among HIV-infected Adults

Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Biological: 0.5 ml of MMR vaccine

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 Type: Interventional
• Enrollment (Actual): 632
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	72 hours after MMR vaccination

Collaborators and Investigators

• Sponsor: Chiang Mai University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: HIV; vaccination; MMR; Serologic response
• Other Study ID Numbers: Research ID: 268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No