Open randomized trial comparing the immunogenicity and safety of a new measles-mumps-rubella vaccine and a licensed vaccine in 12- to 24-month-old children.
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.
Feiterna-Sperling
Cornelia
C
Charité-University Medicine Berlin, Berlin, Germany.
Brönnimann
Rainer
R
Tischer
Annedore
A
Stettler
Peter
P
Durrer
Peter
P
Gaedicke
Gerhard
G
D000914:Antibodies, Viral / Q000097:blood*; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008457:Measles / Q000276:immunology* / Q000517:prevention & control; D008459:Measles virus / Q000276:immunology; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009107:Mumps / Q000276:immunology* / Q000517:prevention & control; D009109:Mumps virus / Q000145:classification / Q000276:immunology; D012409:Rubella / Q000276:immunology* / Q000517:prevention & control; D012412:Rubella virus / Q000276:immunology; D016896:Treatment Outcome; D014611:Vaccination
D000914:Antibodies, Viral; D022542:Measles-Mumps-Rubella Vaccine