A new DTPa-HBV-IPV vaccine co-administered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth.

Three hundred and twenty eligible infants were enrolled in an open randomized clinical trial and allocated to one of two groups to receive either separate concomitant injections of a candidate combined DTPa-HBV-IPV and commercial Hib vaccine (candidate administration: DTPa-HBV-IPV+Hib) or separate concomitant injections of licensed DTPw-IPV mixed in the same syringe with Hib and HBV vaccines (comparator administration: DTPw-IPV/Hib+HBV). Vaccines were administered at 6, 10 and 14 weeks of age preceded by a monovalent dose of HBV at birth. The candidate vaccine administration was shown to be at least as immunogenic (primary objective) as the candidate administration with respect to the diphtheria, tetanus, polio, HBs and PRP seroprotection rates (primary endpoints). Post vaccination, both vaccine administrations showed an equivalent level of seroprotection with nearly all subjects (>96%) acquiring seroprotective titers against diphtheria, tetanus, polioviruses, HBsAg and PRP antigens. A markedly higher anti-HBs response post dose 2 at week 14 in the group receiving the candidate vaccine, 98.6% of subjects had seroprotective titers (GMT of 505.7 mIU/ml) compared with only 88.7% (GMT of 107.5 mIU/ml) in the comparator group. There was a lower incidence of adverse events following the DTPa-based candidate administration compared with the DTPw-based comparator. Despite the early age and short interval between doses, both administrations were immunogenic, with the concomitant administration of DTPa-HBV-IPV and Hib vaccines showing an improved tolerability over the commercial vaccines DTPw-IPV/Hib and HBV.

Epidemiology and control of diphtheria in the Republic of Moldova, 1946-1996.

In 1994-1996, the Republic of Moldova was stricken with an epidemic of diphtheria after >30 years of routine diphtheria immunization and the near absence of the disease for nearly 20 years. The intensity of the epidemic gradually grew, reaching a peak in 1994-1995. The epidemiology of diphtheria in Moldova during this period is described along with laboratory findings and control measures. Pharyngeal diphtheria was the predominant clinical form of the disease (97% of cases), and it most often developed in a localized form (70%), with 20% in the toxic form. The clinical diagnosis of diphtheria was bacteriologically confirmed in 91% of cases: Of the cases tested for biotype, 91.3% were gravis, 8.5% were mitis, and 0. 2% were intermedius. Of 494 toxigenic isolates from cases and carriers at the beginning of the epidemic, 47% were nonphagotypeable strains, and 25.7% were phagotype VI strains. Aggressive population-based diphtheria control measures, a mass immunization campaign, rapid case identification, antibiotic prophylaxis and supplemental immunization of close contacts in clusters of infection, and high coverage with routine immunization rapidly controlled the epidemic within Moldova.

Injections given in healthcare settings as a major source of acute hepatitis B in Moldova.

BACKGROUND: Reported rates of acute hepatitis B are high in many former Soviet Union republics and modes of transmission are not well defined. METHODS: Two case-control studies were undertaken in Moldova to identify risk factors for acute hepatitis B in people aged 2-15 years (children) and > or =15 years (adults). Serologically confirmed acute hepatitis B cases occurring between 1 January 1994 and 30 August 30 1995, were matched on age, sex, and district of residence to three potential controls who were tested for hepatitis B markers to exclude the immune. Stratified odds ratios (SOR) were calculated using bivariate and multivariate methods. RESULTS: In multivariate analysis, compared with the 175 controls, the 70 adult cases (mean age 25 years, 66% male) were more likely to report receiving injections in the 6 months before illness during a dental visit (SOR = 21; 95% CI: 3.7-120), a hospital visit (SOR = 35; 95% CI: 7.2-170), or a visit to the polyclinic (SOR = 13; 95% CI: 2.4-74). Among children, receiving injections during a hospital visit (SOR = 5.2; 95% CI: 1.2-23) was the only exposure reported significantly more often by the 19 cases (mean age 8 years, 68% male) compared with the 81 controls. CONCLUSION: These results, along with reported unsafe injection practices in Moldova, suggest that injections are a major source of hepatitis B virus transmission and highlight the importance of proper infection-control procedures in preventing transmission of blood-borne infections.

PIP: Two case-control studies were conducted between January 1994 and August 1995 to determine the relative importance of injections and other exposures as a source of acute hepatitis B in Moldova among adults (aged 15 years) and children (aged 2-15 years). Results showed that injections in various health care settings were associated with acute hepatitis B and showed a higher proportion among adults compared with children. Contact with an HBsAg-positive person was also associated with illnesses; however, there was no statistically significant association between acute hepatitis B and other exposures. The risk of HBV transmission following percutaneous exposure is high (at least 30%). Calculation of the population attributable to risk suggests that injections associated with acute hepatitis B cases occurred in adults (52%) and children (21%). Adverse effects of injections may not be apparent in causing chronic infections. Transmission of blood-borne pathogens through unsafe injection practices is a problem increasingly identified worldwide.