Measuring and strengthening immunity to measles in young adults fully immunised in childhood - single arm challenge study

Name Administration of MMR by nebulised aerosol to seropositive previously vaccinated young adults Why This study will examine antibody responses and ability to identify measles vaccine virus in oral fluid in young adults with varying levels of seropositivity as a proxy for likely infection if exposed to wild measles virus. What Measles-Mumps-Rubella (MMR) vaccine (Priorix GSK) https://www.medsafe.govt.nz/profs/Datasheet/p/Priorixvac.pdf will be administered using a vibrating mesh nebuliser manufactured by Aerogen Ltd (Ireland). The Aerogen ultra nebuliser with solo vibrating mesh will create an aerosol of reconstituted freeze dried measles, mumps and rubella live attenuated virus with the appropriate particle size for inhalation into the lung. The device is light and handheld. Following instructions, the participant will inhale the vaccine mist using the mouthpiece via slow, natural breathing. Who Trained registered nurses will administer the MMR vaccine via Aerogen nebuliser. The study nurse will assess appropriate aerosol formation and during administration will monitor for completeness of inhaled dose. This is well within the scope of practice for trained registered nurses and specific training videos are available, supplemented by tailored instructions from the manufacturers. How Delivery of 0.3 mL aerosolised MMR vaccine during a face-to-face visit using the device as described above by the staff as described above to consenting eligible participants. Where The intervention will be delivered in a clinical setting in two locations - a student health service in Dunedin and a clinical research centre at the University of Auckland, both of which have all the required infrastructure for delivery of vaccines When and how much Administration of aerosolized MMR vaccine will occur once with four subsequent study visits for biological sampling, the last at 28-31 days after vaccine administration. How well Study nurses will monitor vaccine administration and record whether all visible fluid in the nebuliser chamber has been aerosolised. Measurement of immune responses by antibody assays in serum and detection of measles vaccine virus in oral fluid by PCR will be performed on the biological samples. Delivery of vaccine and monitoring of adverse reactions by study staff in the two sites .

Name Administration of MMR by nebulised aerosol to previously vaccinated young adult student health care workers who have antibody levels to measles or mumps below the positivity thresholds for the Diasorin chemiluminescent assay and are required to receive a third dose of MMR vaccine by University policy and volunteers who have antibody levels to measles and mumps above the threshold Why This study will examine magnitude of increase in measles and mumps antibody responses and ability to identify measles vaccine virus in oral fluid in young adults with varying levels of antibody pre and post MMR by aerosol as a proxy for likely infection if exposed to wild measles virus. What Measles-Mumps-Rubella (MMR) vaccine (Priorix GSK) https://www.medsafe.govt.nz/profs/Datasheet/p/Priorixvac.pdf will be administered using a vibrating mesh nebuliser manufactured by Aerogen Ltd (Ireland). The Aerogen ultra nebuliser with solo vibrating mesh will create an aerosol of reconstituted freeze dried measles, mumps and rubella live attenuated virus with the appropriate particle size for inhalation into the lung. The device is light and handheld. Following instructions, the participant will inhale the vaccine mist using the mouthpiece via slow, natural breathing. Who Trained registered nurses will administer the MMR vaccine via Aerogen nebuliser. The study nurse will assess appropriate aerosol formation and during administration will monitor for completeness of inhaled dose. This is well within the scope of practice for trained registered nurses and specific training videos are available, supplemented by tailored instructions from the manufacturers. How Delivery of 0.3 mL aerosolised MMR vaccine during a face-to-face visit using the device as described above by the staff as described above to consenting eligible participants. Where The intervention will be delivered in a clinical setting in two locations - a student health service in Dunedin and a clinical research centre at the University of Auckland, both of which have all the required infrastructure for delivery of vaccines When and how much Administration of aerosolized MMR vaccine will occur once with four subsequent study visits for biological sampling, the last at 28-31 days after vaccine administration. How well Study nurses will monitor vaccine administration and record whether all visible fluid in the nebuliser chamber has been aerosolised. Measurement of immune responses by antibody assays in serum and detection of measles vaccine virus in oral fluid by PCR will be performed on the biological samples. Delivery of vaccine and monitoring of adverse reactions by study staff in the two sites .