Measles-Rubella Microarray Patches Phase III Clinical Trial Framework: Proposal and Considerations.

Area of Science:

• Vaccinology
• Clinical Trial Design
• Public Health Interventions

Background:

• The Measles-Rubella Microarray Patch (MR-MAP) technology aims to address coverage and equity gaps in measles-containing vaccines (MCVs).
• MR-MAPs are designed for easier programmatic deployment and administration by less-trained health workers, potentially increasing immunization coverage.
• A Phase I/II trial has established the clinical proof-of-concept for MR-MAPs in infants and young children.

Purpose of the Study:

• To present a framework for the pivotal Phase III clinical trial of MR-MAPs.
• To outline considerations for trial design, regulatory approval, and World Health Organization (WHO) prequalification.
• To inform policy decisions regarding the implementation of MR-MAP technology.

Main Methods:

• A proposed Phase III trial will compare the immunogenicity and safety of MR-MAP against subcutaneous MR vaccine in 9- to 10-month-old infants.
• Non-inferiority of immunogenicity will be assessed six weeks post-first dose.
• A potential second dose and subsequent follow-ups are included for further safety and immunogenicity evaluation, if required by regulatory bodies.

Main Results:

• The proposed trial framework is anticipated to generate essential clinical data for MR-MAP regulatory licensure and WHO prequalification.
• The trial design requires confirmation by national regulatory authorities and the WHO prequalification team.
• Further studies may be needed for concomitant vaccine delivery, broader age groups, and impact on coverage/equity.

Conclusions:

• The developed Phase III trial framework provides a pathway for evaluating the MR-MAP.
• Successful completion of the trial is expected to support regulatory approval and WHO prequalification.
• Additional research is necessary to fully understand the potential of MR-MAPs in diverse settings and populations.