MeaslesNCT00962819
Measles, Mumps, and Rubella (MMR) Immunity in College Students
An observational study of Measles and Mumps, run by Sri Edupuganti, MD MPH at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- What is being tested?
- MMR vaccine
- Type of treatment
- Vaccines
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Ability and willing to provide an informed consent
- Documented receipt of MMR-II vaccination in childhood
- Not pregnant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
About this study
Official title: Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine
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.
Read the detailed description
No additional description needed.
- Being tested
- MMR vaccine
- Keywords
- Mumps, Immunity, Vaccine, Mumps antibodies, Mumps immunity
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR vaccineBiological
Also called No other names
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)
| Study group | Role | What they receive |
|---|---|---|
| cross-sectional | College-aged students who were immunized with MMR. Receives: Biological: MMR vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of mumps antibody and levels of memory B and T cell responses
Cross sectional measurement of antibodies to mumps. measles or rubella
Measured: 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
Cross-sectional measurement of antibodies to mumps, measles and rubella
Measured: outcome measurement on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Edupuganti, MD MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Sri Edupuganti, MD MPH, Emory University
- Investigators
- Srilatha Edupuganti, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962819
- Sponsor's protocol ID
- IRB00007373
- Status last verified
- Oct 2021
- First submitted
- 19 May 2008
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18403766Rasheed 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.
PubMed 31481612
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Humoral and Cellular Immune Responses Following Age-appropriate Vaccination With the MMR Vaccine
- ClinicalTrials.gov ID
- NCT00962819
- Acronym / sponsor ID
- IRB00007373
- Keywords
- Mumps, Immunity, Vaccine, Mumps antibodies, Mumps immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sri Edupuganti, MD MPHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross-sectional | – | Biological: MMR vaccineCollege-aged students who were immunized with MMR. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Ability and willing to provide an informed consent
- Documented receipt of MMR-II vaccination in childhood
- Not pregnant
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMR vaccineAlso: No other namesPeople 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) | Biological | cross-sectional |
Primary outcome
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.
Cross sectional measurement of antibodies to mumps. measles or rubella
1 secondary outcome
Determine proportion of college-aged students who are seronegative for mumps
Time frame: outcome measurement on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 18403766Dayan 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.
- Results publication: PubMed 31481612Rasheed 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.
- website for vaccine research clinicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srilatha Edupuganti, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles and Mumps, run by Sri Edupuganti, MD MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.