Clinical trial NCT00962819: Measles, Mumps, and Rubella (MMR) Immunity in College Students
Official title: Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measles
Mumps
Rubella
Keywords: Mumps
Immunity
Vaccine
Mumps antibodies
Mumps immunity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-08-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

Detailed description: No additional description needed.

Eligibility 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

Primary outcomes:
measure: Levels of mumps antibody and levels of memory B and T cell responses
timeFrame: 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 outcomes:
measure: Determine proportion of college-aged students who are seronegative for mumps
timeFrame: outcome measurement on Day 1
Other outcomes:
Locations:
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Srilatha Edupuganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 childhood. Proc Natl Acad Sci U S A. 2019 Sep 17;116(38):19071-19076. doi: 10.1073/pnas.1905570116. Epub 2019 Sep 3.