IMMUNOGENICITY AND REACTOGENICITY OF A COMBINED DTPW-HEPATITIS-B VACCINE IN LITHUANIAN INFANTS

A total of 120 healthy Lithuanian infants were enrolled in a double-bl ind, randomized trial to receive one of two lots of SmithKline Beecham Biologicals' combined diphtheria, tetanus, whole cell Bordatella pert ussis hepatitis B (DTPW-HB) candidate vaccine administered according t o a 0, 1.5, 3-month, primary immunization schedule (beginning at appro ximately 3-4 months of age). The immunogenicity (based on the antibody responses elicited by each of the four vaccine components) and the re actogenicity (based on documented solicited and unsolicited symptoms) of this candidate vaccine were evaluated. Of the 120 subjects enrolled , 100 were included in the analysis of immunogenicity. One month after the third vaccine dose, all infants had protective levels of antibodi es against HBsAg and tetanus toroid and all, except one infant, had pr otective levels of antibodies against the diphtheria toroid (98.9%). A t this time all subjects had responded to the B. pertussis component w ith antibody titres greater than or equal to the assay cut-off. Data c ollected for all enrolled infants were included in the analysis of rea ctogenicity. Most local symptoms were mild and occurred within the fir st 48 h following vaccination. Redness was the most frequently reporte d local symptom and irritability was the most frequently reported gene ral symptom. One vaccine-related serious adverse event was reported (f ever, diarrhea, vomiting and irritability). This event resolved within 20 h without any complications. Conclusion The combined DTPw-HB vacci ne was safe, well-tolerated and immunogenic for all four antigens admi nistered to a population of healthy infants beginning at 3-4 months of age.