Background: Increased mortality rates have been reported after high titer measles [>10(5.0) plaque-forming units (PFU)] vaccination in several large studies in the developing world. An increased titer measles vaccine study conducted in Sudan included a prolonged prospective evaluation of childhood morbidity after vaccination.
Methods: Five hundred ten children (170 per group) were randomized to receive 1 of 3 regimens at 5 and 9 months of age: (1) meningococcal vaccine, then standard titer (50% tissue culture-infective dose, 103.8) Schwarz measles vaccine; (2) increased titer (10(4.7) PFU) Edmonston-Zagreb measles vaccine followed by meningococcal vaccine; and (3) increased titer (10(4.7) PFU) Connaught vaccine followed by standard titer Schwarz measles vaccine.
Results: Health workers collected information at 31,582 semi-monthly and monthly visits during 5 years. No increase in infant mortality was observed, but the statistical power was limited. There were 13, 13 and 10 deaths in the Schwarz, Edmonston-Zagreb and Connaught groups, respectively. There were no differences in duration or incidence of illness between groups at any time during the 5-year follow-up, with comparisons stratified by age and sex. Statistical power for each pairwise comparison was good, with at least 80% power to detect a difference of 1 day per month of illness and a 12% difference in the proportion of visits with an illness recorded.
Conclusions: We were unable to document increased morbidity in recipients of the increased titer measles vaccines used in this study. These data do not support the hypothesis that increased mortality after increased titer vaccine exposure is the result of increased and cumulative morbidity.