BACKGROUND: A trivalent measles-mumps-rubella (MMR) vaccine (MMR Berna) has been developed with a new mumps component, BBM-18, to replace a previously licensed MMR vaccine containing the Rubini mumps strain. Previous studies showed Rubini to confer insufficient long term protection against mumps infection. This study compared the immunogenicity and safety of MMR Berna, which is produced entirely in human diploid cells, with those of the licensed vaccine M-M-RVax (Merck & Co.). METHODS:We vaccinated 467 subjects, 12-24 months of age, in an open, randomized (1:1), phase II, multicenter study. Antibody titers were determined for each vaccine component with a plaque neutralization test (PNT) and a commercial enzyme-linked immunosorbent assay. Solicited local and systemic reactions were recorded in subject diaries for 6 weeks after vaccination. RESULTS:Seroconversion rates 6 to 8 weeks after vaccination for measles and rubella were statistically comparable for the 2 vaccines. However, mumps seroconversion rates were highly assay dependent, with significant differences being measured with the enzyme-linked immunosorbent assay (Berna, 77.4%; Merck, 91.3%; P < 0.001) but not the PNT (Berna, 84.8%; Merck, 87.6%; P = 0.42). The overall rate of systemic reactions was lower in the MMR Berna group (36.8% versus 45.9%; P < 0.05), including a significantly lower rate of fever of >38 degrees C (37.2% versus 51.8%; P < 0.01). CONCLUSIONS: MMR Berna was statistically noninferior to M-M-RVax with respect to seroconversion rates, and the BBM-18 strain elicited a level of functional antimumps antibodies comparable to the Jeryl Lynn strain, as measured with the PNT. Overall, MMR Berna was better tolerated than the comparison vaccine, particularly with respect to the frequency of fever.
RCT Entities:
BACKGROUND: A trivalent measles-mumps-rubella (MMR) vaccine (MMR Berna) has been developed with a new mumps component, BBM-18, to replace a previously licensed MMR vaccine containing the Rubini mumps strain. Previous studies showed Rubini to confer insufficient long term protection against mumps infection. This study compared the immunogenicity and safety of MMR Berna, which is produced entirely in human diploid cells, with those of the licensed vaccine M-M-RVax (Merck & Co.). METHODS: We vaccinated 467 subjects, 12-24 months of age, in an open, randomized (1:1), phase II, multicenter study. Antibody titers were determined for each vaccine component with a plaque neutralization test (PNT) and a commercial enzyme-linked immunosorbent assay. Solicited local and systemic reactions were recorded in subject diaries for 6 weeks after vaccination. RESULTS: Seroconversion rates 6 to 8 weeks after vaccination for measles and rubella were statistically comparable for the 2 vaccines. However, mumps seroconversion rates were highly assay dependent, with significant differences being measured with the enzyme-linked immunosorbent assay (Berna, 77.4%; Merck, 91.3%; P < 0.001) but not the PNT (Berna, 84.8%; Merck, 87.6%; P = 0.42). The overall rate of systemic reactions was lower in the MMR Berna group (36.8% versus 45.9%; P < 0.05), including a significantly lower rate of fever of >38 degrees C (37.2% versus 51.8%; P < 0.01). CONCLUSIONS: MMR Berna was statistically noninferior to M-M-RVax with respect to seroconversion rates, and the BBM-18 strain elicited a level of functional antimumps antibodies comparable to the Jeryl Lynn strain, as measured with the PNT. Overall, MMR Berna was better tolerated than the comparison vaccine, particularly with respect to the frequency of fever.