Moderna is terminating the development of an mRNA vaccine in congenital cytomegalovirus (CMV) after it failed to show any significant benefit in a Phase III trial.
Top line data from the CMVictory trial (NCT05085366) found that the efficacy of mRNA-1647 in preventing CMV infection was far below expectations, ranging between 6% to 23%, missing the primary endpoint of preventing CMV infection in seronegative female participants of childbearing age.
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As a result, the US-based pharma said it will discontinue the development of the candidate in CMV.
Moderna’s CEO Stéphane Bancel, said: “The majority of the data from this trial is still forthcoming, and we will share our full results with the scientific community in hopes that our learnings can contribute to the continued pursuit of a CMV vaccine.”
Despite the lack of efficacy, mRNA-1647 was found to be generally well-tolerated regardless of CMV serostatus, with a safety profile consistent with earlier studies.
The randomised, observer-blind, placebo-controlled study enrolled 7,454 women aged between 16 and 40 years, considered to be of childbearing age.
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By GlobalDataCMV is a common virus that is usually harmless; however, if a mother is first infected during pregnancy, in a small number of cases, it can lead to long-term issues like hearing loss, vision problems, or developmental delays in the child.
There are currently no approved vaccines for CMV. GlobalData’s Pharmaceutical Intelligence Centre reports there are currently 102 ongoing trials of CMV therapies, which can include both treatment and prevention. Of these, 14 are in Phase II/III and Phase III.
This includes a Phase II trial of Fortress Biotech’s CMV vaccine candidate Triplex for patients who are undergoing haematopoietic stem cell transplantation (HSCT).
GlobalData is the parent company of Clinical Trials Arena.
Development to continue in bone marrow transplant
Despite the CMV discontinuation, Moderna added that a Phase II trial (NCT05683457) of the candidate in bone marrow transplant patients will continue. The placebo-controlled trial is investigating the vaccines efficacy in prevention of first clinically significant CMV infection following allogeneic haematopoietic cell transplantation.
CMV can be a potentially serious complication following bone marrow transplant. This is because the immunosuppressive drugs, used to stop the immune system from attacking the transplanted cells, can put a patient at higher risk of serious infection from the virus.
