Informazioni generali
  • Categoria della malattia Infezioni e infestazioni (BASEC)
  • Fase dello studio Phase 3 (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Kyra Denise Zens zens@immunology.uzh.ch (BASEC)
  • Fonte dati BASEC: Importato da 10.02.2026 ICTRP: Importato da 19.01.2024
  • Ultimo aggiornamento 10.02.2026 15:47
HumRes62882 | SNCTP000005564 | BASEC2023-00801 | NCT05894395

MMR Vaccination Study: Investigation of the Immunity of Individuals Fully Vaccinated Against Measles, Mumps, and Rubella and Monitoring of Immunity After a Booster.

  • Categoria della malattia Infezioni e infestazioni (BASEC)
  • Fase dello studio Phase 3 (ICTRP)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Kyra Denise Zens zens@immunology.uzh.ch (BASEC)
  • Fonte dati BASEC: Importato da 10.02.2026 ICTRP: Importato da 19.01.2024
  • Ultimo aggiornamento 10.02.2026 15:47

Descrizione riassuntiva dello studio

Determining whether people respond to vaccination is an important public health question with significant implications for public health. In recent years, there has been an increase in cases of measles and mumps; vaccine-preventable diseases that had been well controlled since the introduction of regular vaccinations. About 30% of measles cases and up to half of mumps cases occur in individuals who have already received at least two doses of measles, mumps, and rubella (MMR) vaccine, suggesting waning immunity. The duration of protective immunity against rubella is also unclear. While two doses of MMR vaccine are recommended for all adults born after 1963 in Switzerland, an MMR booster as a third dose is currently not planned. Furthermore, blood is usually used to assess immunity, generally measuring the circulating immunity, typically the antibody response. While antibody responses may indicate a reaction to vaccination, they may not represent the immune group actually responsible for protection. There is a need to better understand both, first, the duration of vaccine-induced immune responses to measles, mumps, and rubella and, second, the underlying protective immune mechanisms triggered by vaccination and their localization. In this study, the immunogenicity, the ability of an antigen to elicit an immune response, of a third dose (booster) of the MMR vaccine (M-M-RVaxPro) in healthy adults (18-49 years) who have previously received two doses of MMR vaccine will be investigated. Additionally, immune responses in blood will be compared to those in mucosal sites (saliva and nasal rinses).

(BASEC)

Intervento studiato

In our study, participants will be randomly assigned to groups. This is important to obtain reliable results from the study. This is called randomization. Each group receives a different treatment. In our study, there are 2 groups:

 

• Group 1 (experimental group) receives the booster. 50 participants will receive the booster of the MMR vaccine (M-M-RVaxPro) and will be invited for five study visits over one year. During these visits, blood and saliva samples and a nasal rinse will be collected for immunity studies.

 

• Group 2 represents the participants not receiving the booster. We study the immunity of previously vaccinated individuals. The approximately 150 participants in this group will be invited for two study visits over one year. Directly at study enrollment and one year later, blood and saliva samples will be collected.

 

This division helps to understand how MMR-specific immune responses decline over time and whether the booster is effective. Such information may provide evidence of effectiveness for the booster in at-risk populations if needed.

(BASEC)

Malattie studiate

Measles, mumps, and rubella are highly contagious viral diseases for which there is no specific treatment and which are often mistakenly considered harmless. Without vaccination, these diseases regularly cause outbreaks due to their high contagiousness. They are transmitted from person to person through droplets produced when coughing or sneezing. Although many people recover after a few days, these diseases can lead to severe and debilitating symptoms. Additionally, severe complications can occur, potentially causing permanent physical or mental damage and, in rare cases, death. Vaccination is the only effective means of protecting against these diseases. Therefore, it is recommended in Switzerland and worldwide to vaccinate all children with two doses of the MMR vaccine to eliminate these diseases.

(BASEC)

Criteri di partecipazione
• Aged 18-49 years and "generally healthy" • Has received exactly two previous doses of an MMR-containing vaccine • Written consent to participate in the study • Able to attend study visits (BASEC)

Criteri di esclusione
• Pregnancy, breastfeeding, or intention to become pregnant during the study • Receipt of another vaccination less than 1 month prior • Previous adverse reaction after receiving an MMR-containing vaccine • Individuals with confirmed or suspected immunosuppression or immunodeficiency (e.g., severe combined immunodeficiency, AIDS, chemotherapy, etc.) • Current or chronic or severe illnesses (e.g., tuberculosis, diabetes, uncontrolled high blood pressure, etc.) (BASEC)

Luogo dello studio

Zurigo

(BASEC)

Switzerland (ICTRP)

Sponsor

Prof. Dr. Jan Fehr (Sponsor Investigator)

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Kyra Denise Zens

+41 44 634 46 72

zens@immunology.uzh.ch

University of Zurich

(BASEC)

Informazioni generali

Department Head,

+41 44 634 46 72

phung.lang@uzh.ch

(ICTRP)

Informazioni scientifiche

Department Head,

+41 44 634 46 72

phung.lang@uzh.ch

(ICTRP)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

07.07.2023

(BASEC)


ID di studio ICTRP
NCT05894395 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)

Titolo accademico
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 (ICTRP)

Titolo pubblico
Immunity in Persons Fully Vaccinated Against Measles, Mumps and Rubella and Responses to Booster Vaccination (ICTRP)

Malattie studiate
Mumps;Measles;Rubella (ICTRP)

Intervento studiato
Biological: MMR booster vaccination (as M-M-R-VaxPro) (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: 49 Years
Minimum age: 18 Years

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
(ICTRP)

non disponibile

Endpoint primari e secondari
Immunogenicity post MMR-booster vaccination (ICTRP)

Assessment of Immunoglobulin A (IgA) blood and mucosal immune responses to each virus (measles, mumps, and rubella);Assessment of Immunoglobulin G (IgG) blood and mucosal immune responses to each virus (measles, mumps, and rubella);Assessment of virus-specific B cell blood and mucosal immune responses to each virus (measles, mumps, and rubella);Assessment of virus-specific T cell blood and mucosal immune responses to each virus (measles, mumps, and rubella) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Merck Sharp & Dohme LLC (ICTRP)

Contatti aggiuntivi
Jan Fehr, M.D.;Phung Lang, Ph.D., phung.lang@uzh.ch, +41 44 634 46 72, Department Head, (ICTRP)

ID secondari
MIPS101124 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05894395 (ICTRP)

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile