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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962819
Other study ID # IRB00007373
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date December 2012

Study information

Verified date October 2021
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

No additional description needed.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States The Hope Clinic of the Emory Vaccine Center Decatur Georgia

Sponsors (2)

Lead Sponsor Collaborator
Sri Edupuganti, MD MPH Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dayan GH, Quinlisk MP, Parker AA, Barskey AE, Harris ML, Schwartz JM, Hunt K, Finley CG, Leschinsky DP, O'Keefe AL, Clayton J, Kightlinger LK, Dietle EG, Berg J, Kenyon CL, Goldstein ST, Stokley SK, Redd SB, Rota PA, Rota J, Bi D, Roush SW, Bridges CB, Santibanez TA, Parashar U, Bellini WJ, Seward JF. Recent resurgence of mumps in the United States. N Engl J Med. 2008 Apr 10;358(15):1580-9. doi: 10.1056/NEJMoa0706589. — View Citation

Rasheed MAU, Hickman CJ, McGrew M, Sowers SB, Mercader S, Hopkins A, Grimes V, Yu T, Wrammert J, Mulligan MJ, Bellini WJ, Rota PA, Orenstein WA, Ahmed R, Edupuganti S. Decreased humoral immunity to mumps in young adults immunized with MMR vaccine in child — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of mumps antibody and levels of memory B and T cell responses 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 Determine proportion of college-aged students who are seronegative for mumps Cross-sectional measurement of antibodies to mumps, measles and rubella outcome measurement on Day 1
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