MMR Vaccination Among HIV-infected Adults

Phase 4

Completed

• Conditions: HIV
• Interventions: Biological: 0.5 ml of MMR vaccine

• Registration Number: NCT02724852
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-09
• Study Completion: 2014-03
• Status Verified: 2016-03
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 632

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-infected adults	0.5 ml of MMR vaccine	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.
HIV-uninfected adults	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with protective antibodies to measles, mumps, and rubella	Baseline	Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants

Secondary Outcome Measures

Name	Time	Method
The geometric means of anti-rubella IgG level	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
Proportion of participants with protective antibodies to measles, mumps, and rubella	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
The geometric means of anti-measles IgG level	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
The geometric means of anti-mumps IgG titers	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
Proportion of participants who had adverse effects from vaccination	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

Trial Locations

Locations (1)

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University; 🇹🇭 Muang, Chiang Mai, Thailand