Immunity in Persons Fully Vaccinated Against Measles, Mumps and Rubella and Responses to Booster Vaccination
MIPS
A Cross-Sectional and Open Pre-Post Interventional Study Evaluating Circulating and Mucosal Humoral and Cell-Mediated Immunity Following Measles, Mumps and Rubella (MMR) Vaccination in Adults
1 other identifier
interventional
200
1 country
2
Brief Summary
The purpose of this study is to investigate the immunity of persons fully vaccinated against measles, mumps and rubella and to examine the course of immunity after booster vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJanuary 8, 2024
January 1, 2024
1.2 years
May 30, 2023
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Immunogenicity post MMR-booster vaccination
Immunogenicity will be assessed by evaluating anti-measles, -mumps, and -rubella serum Immunoglobulin G (IgG) titers post-booster vaccination. A 5-fold increase in titers for each virus between baseline (day 0) and day 28 post-booster vaccination will be considered "immunogenic".
From admission to one year post vaccination
Secondary Outcomes (4)
Assessment of Immunoglobulin A (IgA) blood and mucosal immune responses to each virus (measles, mumps, and rubella)
From admission to one year post vaccination
Assessment of Immunoglobulin G (IgG) blood and mucosal immune responses to each virus (measles, mumps, and rubella)
From admission to one year post vaccination
Assessment of virus-specific B cell blood and mucosal immune responses to each virus (measles, mumps, and rubella)
From admission to one year post vaccination
Assessment of virus-specific T cell blood and mucosal immune responses to each virus (measles, mumps, and rubella)
From admission to one year post vaccination
Study Arms (2)
MMR Booster Vaccination Arm
EXPERIMENTALParticipants (adults 18+ having previously received 2 lifetime doses of MMR-containing vaccine) will receive a single MMR booster vaccination (3rd lifetime dose) as M-M-R-VaxPro.
Observational Arm
NO INTERVENTIONParticipants (adults 18+ having previously received 2 lifetime doses of MMR-containing vaccine) will be assessed at study enrollment and at a 1 year follow-up visit
Interventions
a single dose of MMR-containing vaccine (as M-M-R-VaxPro), in adults having previously received 2 lifetime doses of MMR-containing vaccine
Eligibility Criteria
You may qualify if:
- Aged 18-49 (inclusive) at the time of the study screening visit
- Has received exactly two previous doses of MMR-containing vaccine at any point up to one calendar year prior to the study screening visit
- Willing to receive a booster MMR vaccination as outlined in the study protocol
- Able and willing to comply with all other study requirements (attend all study visits and provide blood, saliva, nasal wash samples at each visit as outlined)
- Sufficient language (German or English) and cognitive skills
- Provides written, informed consent to participate in the study
You may not qualify if:
- Acute respiratory or other infections (postpone baseline visit until resolved)
- Receipt of any other vaccination less than 4 weeks prior to the baseline visit or intention to receive another vaccination within 4 weeks following the baseline visit
- Previous hypersensitivity reaction following receipt of any MMR-containing vaccine or previous hypersensitivity reaction to any component of M-M-R-vaxPro
- Pregnancy, lactation, or intention to become pregnant during the study
- Individuals with confirmed or suspected immunosuppressive or immune-deficient state
- Known current or chronic or severe disease
- Receipt of blood or plasma transfusions, or administration of immune globulin (IG) less than 12 weeks prior to the baseline visit, or intention to receive IG within 4 weeks following the baseline visit
- Any other significant disease, disorder, or finding which could potentially result in an increased risk to the volunteer due to participation in the study
- Being enrolled in another interventional study that may interfere with the current study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Epidemiology, Biostatistics and Prevention Institute University of Zurich
Zurich, 8001, Switzerland
Epidemiology, Biostatistics and Prevention Institute University of Zurich
Zurich, 8001, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Fehr, M.D.
Department Head
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 8, 2023
Study Start
December 1, 2023
Primary Completion
March 1, 2025
Study Completion
September 1, 2025
Last Updated
January 8, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share