Merck announced that the company is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. The first study (ClinicalTrials.gov, NCT03480763) will evaluate the safety, tolerability and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent one year later in healthy adult subjects 50 years of age or older. The second Phase 3 study (ClinicalTrials.gov, NCT03480802) will evaluate the safety, tolerability and immunogenicity of PCV-15 followed by Pneumococcal Vaccine Polyvalent administered eight weeks later in adults infected with human immunodeficiency virus (HIV).
The decision to move PCV-15 to Phase 3 is based on the findings of Phase 1 and Phase 2 studies, the results of which are being presented at the upcoming International Society on Pneumococci and Pneumococcal Diseases (ISPPD), which begins on Sunday, April 15.
“Merck has been a pioneer in pneumococcal and infectious disease prevention. We are building on this heritage with the development program for PCV-15,” said Eliav Barr, M.D. senior vice president, Merck Research Laboratories. “Based on our Phase 1 and 2 studies of PCV-15 findings, we are initiating a comprehensive Phase 3 program to further evaluate this investigational vaccine.”