The use of a concentrate containing milk immunoglobulins prepared from rotavirushyperimmunized cows (neutralization titer, 1:6,000 for a 10070 solution) to treat infants hospitalized for acute rotavirus gastroenteritis resulted in a significant (P = . (08) reduction in the duration of excretion of virus. Stool samples from treated infants showed the presence of bovine milk immunoglobulins in 47% of cases and of neutralizing activity in 43% (mean neutralization titer, 1:48); stool samples from control infants showed neutralizing activities in only 30J0 of cases (neutralization titers, <1:20). Immunoelectrophoresis of stool extracts revealed fragment A, a bovine analogue of Ftab'), or Fab, as the major product of in vitro and in vivo digestion of the immunoglobulins. Cessation of excretion of virus correlated with the appearance of neutralizing activities in 19 of 25 infants. Only concentrate-treated infants with high neutralizing activity in stools showed a statistically significant reduction in duration of excretion of virus; this duration in concentrate-treated infants with low neutralizing activity was comparable with controls.

A milk immunoglobulin concentrate (MIC) containing antibodies to enteropathogenic E. coli strains was prepared by hyperimmunisation of pregnant cows and using the milk obtained during the first 6 to 8 days of lactation. The sterile concentrate contained 70 to 80% protein and 35 to 40% immunoglobulin. The antibacterial activity was measured by bacterial passive agglutination, bacteriostatic activity in vitro, phagocytic clearance in vivo, and a protection test in mice. Though differences in titers were observed, adequate immunologic activity was demonstrated by these tests. Clinical studies were performed with 60 patients (aged 10 days to 18 months) suffering from diarrhoea with isolation of enteropathogenic E. coli. They were treated for 10 days with MIC and stool cultures were done prior to, during, and 2, 3 and 4 days after termination of treatment. Among 51 patients infected with E. coli strains incorporated in the vaccine, stool cultures became negative in 43 (84.3%) after treatment with MIC and 8 remained positive. Nine patients infected with strains O 78:K80(B-) and O 114:K--(B-)--which were not included in the vaccine used for immunisation--served as controls. Only one patient in this group became negative. If all patients receiving antibiotics for non intestinal infections during the treatment period are omitted the results remained unaltered: MIC was effective in 32 out of 38 patients (84.2%). These differences were highly significant. These results provide evidence that treatment with specific MIC is effective in eliminating enteropathogenic E. coli from the intestine.

Pregnant cows were successfully hyperimmunized with all four human rotavirus serotypes, resulting in a 100-fold increase in neutralizing milk antibody titers over those of controls. Milk antibodies were isolated batchwise from 1,000 kg of pooled milk for the first 10 lactation days, yielding 10 kg of freeze-dried milk immunoglobulin concentrate consisting of 50% bovine milk immunoglobulin. Milk immunoglobulin concentrate showed neutralizing activities against all four human rotavirus serotypes that were 100 times higher than those in pooled human milk samples and 10 times higher than those in a commercial pooled immunoglobulin preparation from pooled human blood serum. In vitro neutralization tests showed that milk immunoglobulin concentrate had powerful antiviral activity, even against very high doses of infectious rotaviruses. Because the technology of the milk immunoglobulin concentrate ensures that it is innocuous and can be used for oral application, it is proposed that milk immunoglobulin concentrate be used to induce passive immunity to infantile rotavirus gastroenteritis.