MMR Vaccination Among HIV-infected Adults

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724852
• Other study ID #: Research ID: 268
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2016
• Last updated: March 31, 2016
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Research Institute for Health Sciences
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University	Muang	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes