MMR Vaccination Study: Investigation of the Immunity of Individuals Fully Vaccinated Against Measles, Mumps, and Rubella and Monitoring of Immunity After a Booster.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
• 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)
Critères d'exclusion
• 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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Prof. Dr. Jan Fehr (Sponsor Investigator)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Kyra Denise Zens
+41 44 634 46 72
zens@clutterimmunology.uzh.chUniversity of Zurich
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
07.07.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05894395 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Immunity in Persons Fully Vaccinated Against Measles, Mumps and Rubella and Responses to Booster Vaccination (ICTRP)
Maladie en cours d'investigation
Mumps;Measles;Rubella (ICTRP)
Intervention étudiée
Biological: MMR booster vaccination (as M-M-R-VaxPro) (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Merck Sharp & Dohme LLC (ICTRP)
Contacts supplémentaires
Jan Fehr, M.D.;Phung Lang, Ph.D., phung.lang@uzh.ch, +41 44 634 46 72, Department Head, (ICTRP)
ID secondaires
MIPS101124 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05894395 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible