Measuring and strengthening immunity to measles in young adults fully immunised in childhood - a randomised controlled trial (RCT)

Not Applicable

• Conditions: Waning measles immunity in vaccinated young adults; Immune health; Public Health - Other public health; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12623000130662
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

*Antibody below threshold for positivity of the Diasorin assay for either or both of measles/mumps antibody and required to have a dose of MMR vaccine by University of Otago Screening and Immunisation Policy
*Capable and willing to give written informed consent
*Residing in Dunedin
*Able and willing to participate for the duration of the study visits and follow-up
*Willing to provide verifiable identification at study entry and follow-up visits
*Daily access to an internet-connected device (smart phone, tablet, laptop or PC) and willing to complete an electronic diary post vaccination.

Exclusion Criteria

Contraindications to MMR as specified in the NZ Immunisation Handbook. These include:
•proven anaphylaxis to the vaccine or vaccine component (eg, neomycin or gelatin)
•significant immunocompromise: impaired cell-mediated immunity, including untreated malignancy, type 1 interferon receptor (IFNAR) signalling pathway defects, immunosuppressive drug therapy, including high-dose steroids, receiving high-dose radiotherapy, HIV infection with severely impaired T cell immunity
•another live vaccine, including Bacillus Calmette-Guérin (BCG), within the previous 4 weeks
•pregnant women – pregnancy should be avoided for four weeks after immunization
•participants pregnant during study participation may complete follow-up.
•intravenous immunoglobulin or blood transfusion during the preceding 11 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants who develop measles antibody above the threshold for measles protection in the serum microimmune assay (MIA) in National Public Health Laboratory Netherlands (RIVM). The established threshold in serum is - 0.12 IU/ml., which is strongly correlated with the Plaque Reduction Neutralisation Titre (PRINT) WHO standard.[28 days and 12 months post MMR ];Percentage of participants in whom measles vaccine virus is present in oral fluid (by PCR assay)[3-4, 7, 14 days post MMR]

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who develop measles antibody in serum above the threshold for measles protection by microimmune assay (MIA) at earlier time points. [At 3-4, 7 and 14 days post MMR];Geometric mean serum antibody titres (GMTs) [7, 14, and 28 days post MMR; 12 months post MMR]