Measles, Mumps, and Rubella (MMR) Immunity in College Students

October 1, 2021 updated by: Sri Edupuganti, MD MPH

Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine

This study will lay the foundation for determining the underlying reasons for lack of immunity to mumps that led to the 2006 mumps outbreak on college campuses in the Mid West, and it will assess the potential for similar outbreaks of measles and rubella. A total of 70 to 80 college students (age 18 to 22) on the Emory campus (or nearby college campuses or the community) will be assessed for antibodies to measles, mumps or rubella by drawing a one-time blood sample. Their medical records will be verified for documentation of immunization with MMR vaccine prior to enrollment in the study. If a study volunteer is found to not have MMR immunity, they will be offered an MMR-II vaccine. For this group, additional blood specimens will be obtained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No additional description needed.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30030
        • The Hope Clinic of the Emory Vaccine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects for this study will be 18-22 year olds recruited from Emory University's student population who have received two age-appropriate doses of the MMR-II vaccine.

Description

Inclusion Criteria:

  • Ability and willing to provide an informed consent
  • Documented receipt of MMR-II vaccination in childhood
  • Not pregnant

Exclusion Criteria

  • No history of HIV infection.
  • Immunocompromised health status due to HIV infection, cancer, diabetes, liver, lung or kidney diseases, autoimmune diseases, history of splenectomy.
  • Use of immunosuppressive medications within last 2 to 3 months (oral or parenteral corticosteroids or cytotoxic medications)
  • Medical conditions that require the use of immunosuppressive medications
  • Received blood or blood products within the last 30 days
  • Any vaccines received in the last 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cross-sectional
College-aged students who were immunized with MMR.
Biological: MMR vaccine
People with no antibodies to either mumps, measles and rubella will be offered the MMR vaccine (they may choose to or choose not to receive the MMR vaccine)
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of mumps antibody and levels of memory B and T cell responses
Time Frame: Day 1 for all participants except for those who receive MMR vaccine, there will be additional outcome measures on Day 0, 7, 14 and 28 post-vaccination.
Cross sectional measurement of antibodies to mumps. measles or rubella
Day 1 for all participants except for those who receive MMR vaccine, there will be additional outcome measures on Day 0, 7, 14 and 28 post-vaccination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine proportion of college-aged students who are seronegative for mumps
Time Frame: outcome measurement on Day 1
Cross-sectional measurement of antibodies to mumps, measles and rubella
outcome measurement on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sri Edupuganti, MD MPH

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Srilatha Edupuganti, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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