mRNA-1345-P303: mRNA-1345 vaccine targeting RSV in high risk adults
Research type
Research Study
Full title
A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults
IRAS ID
1007940
Contact name
Laila El Asmar
Contact email
Sponsor organisation
ModernaTX, Inc.
Research summary
Lower respiratory tract infections are common in older adults. Respiratory Syncytial Virus (RSV) is increasingly recognised as a major cause of illness in adults with existing conditions and adults who are immunocompromised, like recipients of organ transplant.
There are no approved vaccines against RSV and no approved therapies for adults with RSV. Moderna Tx, Inc. developed an injection platform based on a mRNA delivery system. mRNA-1345 is designed to prevent disease associated with RSV infection. The current study is supported by results from non-clinical and Phase 1 and 2/3 studies.
There are 2 parts:
• The purpose of Part A (1500 patients) is to evaluate the safety and immune response to mRNA-1345 in adults with existing conditions.
• The purpose of Part B (150 patients) is to evaluate the safety and immune response to mRNA-1345 in adults who are immunocompromised.
All patients will receive an injection of mRNA-1345 on Day 1. Patients in Part B will also receive an injection on Day 58. All patients will have study visits on Days 8 (phone), 15, and 29; and Months 3 (phone), 6, 9 (phone), and 12; a phone call every 3 months; and an end of study visit 2 years after the injection. Patients in Part B will have 3 extra study visits after their second injection: Days 65 (phone), 73, and 87.
Study procedures include physical examination, vital signs, blood testing, nasopharyngeal swabs, and completion of an eDiary.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0126
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion