Measles Clinical Trial
Official title:
Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine
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 |
Verified date | October 2021 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Hope Clinic of the Emory Vaccine Center | Decatur | Georgia |
Lead Sponsor | Collaborator |
---|---|
Sri Edupuganti, MD MPH | Merck Sharp & Dohme Corp. |
United States,
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
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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