NCT02724852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for phase_4 hiv

Timeline
Completed

Started Jul 2011

Typical duration for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

March 25, 2016

Last Update Submit

March 31, 2016

Conditions

HIV

Keywords

MMRvaccinationHIVSerologic response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

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

    8-12 weeks after a single dose of MMR vaccination

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

    48 weeks after a single dose of MMR vaccination

  • The geometric means of anti-measles IgG level

    8-12 weeks after a single dose of MMR vaccination

  • The geometric means of anti-measles IgG level

    48 weeks after a single dose of MMR vaccination

  • The geometric means of anti-mumps IgG titers

    8-12 weeks after a single dose of MMR vaccination

  • +4 more secondary outcomes

Study Arms (2)

HIV-infected adults

ACTIVE COMPARATOR

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

HIV-uninfected adults

EXPERIMENTAL

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

Interventions

0.5 ml of MMR vaccineBIOLOGICAL

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

HIV-infected adultsHIV-uninfected adults

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Muang, Chiang Mai, 50200, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 27138005DERIVED

MeSH Terms

Interventions

Measles-Mumps-Rubella Vaccine

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Study Officials

  • Romanee Chaiwarith, MD

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 25, 2016

First Posted

March 31, 2016

Study Start

July 1, 2011

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)