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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00962819
First received: May 19, 2008
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Measles
Mumps
Rubella
Biological: MMR vaccine
Phase 4

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Cross sectional measurement of antibodies to mumps. measles or rubella


Secondary Outcome Measures:
  • Determine proportion of college-aged students who are seronegative for mumps [ Time Frame: outcome measurement on Day 1 ] [ Designated as safety issue: No ]
    Cross-sectional measurement of antibodies to mumps, measles and rubella


Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 74
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: No other names

Detailed Description:

No additional description needed.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962819

Locations
United States, Georgia
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
Sponsors and Collaborators
Sri Edupuganti, MD MPH
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Srilatha Edupuganti, MD Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Sri Edupuganti, MD MPH, Assistant Prfessor, Emory University
ClinicalTrials.gov Identifier: NCT00962819     History of Changes
Other Study ID Numbers: IRB00007373
Study First Received: May 19, 2008
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Mumps
Immunity
Vaccine
Mumps antibodies
Mumps immunity

Additional relevant MeSH terms:
Measles
Mumps
Parotitis
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on August 28, 2014