Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05894395
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-05-30
Brief Title:
Immunity in Persons Fully Vaccinated Against Measles Mumps and Rubella and Responses to Booster Vaccination
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIPS
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
Detailed Description:
Determining whether individuals respond to vaccination is an important healthcare question with significant public health impact In recent years there have been surges in cases of measles and mumps vaccine-preventable diseases which have previously been well-controlled since the introduction of regular vaccination as MMR in the 1970s-80s Since 2016 approximately 10000-15000 cases each of measles and mumps have been reported annually in Europe Despite high vaccination coverage and being declared measles endemic free multiple outbreaks have occurred in Switzerland affecting predominately older adults and young children While rubella cases remain relatively uncommon infection during pregnancy can result in Congenital Rubella Syndrome and lead to severe birth defects underscoring the importance of adequate prevention All three viruses are highly contagious and transmitted through the oralrespiratory mucosal tissue by contact with infected respiratory secretions
Importantly in recent years approximately 30 of measles cases and up to half of mumps cases have been found to occur in individuals receiving at least 2 previous MMR doses suggesting waning immunity Although seroconversion after two doses of mumps vaccine as MMR nears 90-100 field effectiveness is closer to 88 range 75-95 Booster immunization however is not currently indicated in adults Furthermore while serum virus-neutralizing antibodies are evaluated as an indicator of responsiveness following mumps vaccination they are not the correlate of protective immunity There is need to better understand both 1 The duration of vaccine-elicited protection to all three viruses and 2 The underlying protective immune mechanisms elicited by vaccination
Assessments of vaccine responses most often utilize blood to evaluate the establishment of circulating immunity typically antibodies in individuals While antibody responses may predict response to vaccination they may or may not be the immune subset actually responsible for protection Furthermore circulating immune responses detectable in the blood are not necessarily representative of responses occurring at mucosal sites Samples such as saliva sputum or nasal washes in contrast can be collected with relative ease and can provide insights into the oral and respiratory mucosal environments which are primary sites of pathogen exposure Understanding whether specific vaccines elicit immune responses at mucosal sites that are detectable using minimally-invasive techniques that correlate with protection from disease or that can act as a surrogate for circulating responses would be highly valuable in immune monitoring
With this study the investigators plan to evaluate persisting measles mumps and rubella seropositivity in previously-vaccinated adults and to assess whether anti-viral immune responses are detectable in saliva representative of the oral mucosa as well as how these compare to circulating responses detectable in the blood In a random subset of study participants they will offer a booster immunization and subsequently evaluate mucosal and circulating immune responses in the saliva nasal washes representative of the oral and respiratory mucosae and blood 7 and 28 days and 1 year post-vaccination to determine whether additional predictive indicators for measles mumps andor rubella immunity can be identified
Significantly the proposed study has the potential to 1 Provide unique insights into similarities and differences between mucosal and circulating anti-viral immune responses to MMR vaccination as well as the duration of such responses 2 Aid in the identification of a correlate of immune protection or novel indicator of responsiveness to mumps and possibly measles and rubella vaccination and 3 Improve immune monitoring after MMR vaccination by using saliva andor nasal washes to reduce invasiveness and provide a proof-of-concept for future studies
Importantly in recent years approximately 30 of measles cases and up to half of mumps cases have been found to occur in individuals receiving at least 2 previous MMR doses suggesting waning immunity Although seroconversion after two doses of mumps vaccine as MMR nears 90-100 field effectiveness is closer to 88 range 75-95 Booster immunization however is not currently indicated in adults Furthermore while serum virus-neutralizing antibodies are evaluated as an indicator of responsiveness following mumps vaccination they are not the correlate of protective immunity There is need to better understand both 1 The duration of vaccine-elicited protection to all three viruses and 2 The underlying protective immune mechanisms elicited by vaccination
Assessments of vaccine responses most often utilize blood to evaluate the establishment of circulating immunity typically antibodies in individuals While antibody responses may predict response to vaccination they may or may not be the immune subset actually responsible for protection Furthermore circulating immune responses detectable in the blood are not necessarily representative of responses occurring at mucosal sites Samples such as saliva sputum or nasal washes in contrast can be collected with relative ease and can provide insights into the oral and respiratory mucosal environments which are primary sites of pathogen exposure Understanding whether specific vaccines elicit immune responses at mucosal sites that are detectable using minimally-invasive techniques that correlate with protection from disease or that can act as a surrogate for circulating responses would be highly valuable in immune monitoring
With this study the investigators plan to evaluate persisting measles mumps and rubella seropositivity in previously-vaccinated adults and to assess whether anti-viral immune responses are detectable in saliva representative of the oral mucosa as well as how these compare to circulating responses detectable in the blood In a random subset of study participants they will offer a booster immunization and subsequently evaluate mucosal and circulating immune responses in the saliva nasal washes representative of the oral and respiratory mucosae and blood 7 and 28 days and 1 year post-vaccination to determine whether additional predictive indicators for measles mumps andor rubella immunity can be identified
Significantly the proposed study has the potential to 1 Provide unique insights into similarities and differences between mucosal and circulating anti-viral immune responses to MMR vaccination as well as the duration of such responses 2 Aid in the identification of a correlate of immune protection or novel indicator of responsiveness to mumps and possibly measles and rubella vaccination and 3 Improve immune monitoring after MMR vaccination by using saliva andor nasal washes to reduce invasiveness and provide a proof-of-concept for future studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None