NCT00962819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2008

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

May 19, 2008

Last Update Submit

October 1, 2021

Conditions

Keywords

MumpsImmunityVaccineMumps antibodiesMumps immunity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Determine proportion of college-aged students who are seronegative for mumps

    outcome measurement on Day 1

Study Arms (1)

cross-sectional

College-aged students who were immunized with MMR.

Biological: MMR vaccine

Interventions

MMR vaccineBIOLOGICAL

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)

Also known as: No other names
cross-sectional

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

Related 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.

    PMID: 18403766BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

MeaslesMumpsRubella

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae Infections

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Study Officials

  • Srilatha Edupuganti, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Prfessor

Study Record Dates

First Submitted

May 19, 2008

First Posted

August 20, 2009

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations