In a prospective study, 200 infants were randomized equally to receive either pneumococcal saccharides 4,9V,14,19F, 23F,18C at 2ug per type and 6B at 4 ug conjugated to CRM197 (PNCRM7) or a control vaccine. Immunizations were given at 2, 4, and 6 mo. of age concurrently with DTP/HbOC and OPV. Serum IgG antibody to pneumococcal serotypes was measured by standardized EIA methods.

Serology results on pre and post vaccination sera from the first 50 children: Table Serum immune responses to HbOC were comparable in the PNCRM7 and control groups.

Table 1
Full size table

Local reaction rates in the legs injected with PNCRM7 and control vaccine were ≤ those in the DTP/HbOC legs; data are still under code.

PNCRM7 is safe and immunogenic. Antibody responses varied from moderate to excellent. Based upon these encouraging results, PNCRM7 efficacy trials are in progress.