TABLE 34.

Neonatal Hepatitis B Vaccination

SourceLocation and Type of TrialInterventionProgram Impact
Chen et al562; Kao et al567; Chen et al563Taiwan; community-based QTIn July 1984, a nationwide vaccination program was started. Preparatory work was done 1 y before the program started. It included education of doctors, allied health workers and public laboratory facilities in testing HBsAg and hepatitis B virus “e” antigen (HBeAg). A confidential registration data bank was formed. Infants born to HBsAg-positive mothers were given the vaccine at ages 1, 5, and 9 wk and then a booster at 12 mo. Infants born to mother testing positive for both antigens received a hepatitis B immunoglobulin within 24 hours along with the vaccines.87% of the children received at least 3 doses of vaccine. The overall prevalence rate of HBsAg decreased from 9.8% in 1984 to 1.3% in 1994 in children <10 y of age. A statistically significant decrease was observed in every age group between 1 and 10 y. The overall prevalence rate of HBeAg was 26% in 1984, 15% in 1989 and 4% in 1994. The average annual incidence of hepatocellular carcinoma in Taiwanese children aged 6–14 y declined from 0.7 per 100 000 children in 1981–1986 to 0.36 per 100 000 in 1990–1994. The average mortality associated with fulminant hepatitis in infants from 1975–1984 was 5.36/100 000 infants (range: 2.9–6.7), which decreased to 1.71/100 000 (range: 0.3–4.6) for the period 1985–1998. Thus, the mortality rate decreased threefold after the vaccination program.
The Gambia Hepatitis Study Group566; The Gambia Hepatitis Study Group565; Montesano564The Gambia; community-based QTChildren (n = 60 000) were divided into 2 groups. 1 group received routine EPI vaccination, and the other received routine EPI vaccination plus the hepatitis B vaccine. This continued from 1986–1990, after which all children were given hepatitis B vaccine and it became a part of the standard EPI. The first dose was given at the same time as BCG vaccine (ie, during the first month of life). The second dose was given along with a first dose of triple antigen at 2 mo of age or later. The third dose was given with the third dose of triple antigen at 4 mo of age or later. A minimum interval between doses was fixed at 4 wk. A cohort of 1000 children was followed long-term to measure immunogenicity.The coverage survey showed that 98% of children aged 12–18 mo had received the first dose, 94% had received the second dose and 74% had received the third. In 94% of children, immunization produced protective levels of antibodies at 1 y of age. As a result of the vaccination program, protection against infection was >80% and the protection against carriage status was >90%.
Odusanya et al725Nigeria; community- based QTImmunization and preprimary health care services were commenced for children (n = 327) in a rural community in Nigeria. Hepatitis B vaccine was administered at birth and then in a single injection with diphtheria-tetanus-pertussis vaccine at 6 wk of age and another at 3 mo of age.2 y after the program was started, the immunization coverage rates were 94% for BCG, 88% for diphtheria-tetanus-pertussis vaccine (third dose) and 82% for measles. Hepatitis B coverage for all 3 doses was 58%.
Ariwan726Indonesia; community- based QTHealthy Start Program in Indonesia involved a visit by the village midwife between 1 and 7 d after birth to provide Hepatitis B vaccination and maternal care/education.Hepatitis B vaccination rate increased from 0% in 1990 to 84% in 1996. IMR decreased from 73/1000 to 55/1000 live births, due to other aspects of the maternal care and education program.
Poovorwan et al727Thailand; community-based QTHepatitis B vaccination has been an integral part of the EPI since 1992. In each of 5 representative provinces, 400–488 healthy immunocompetent infants ranging from 6 to 18 mo of age were evaluated by examining their sera for viral hepatitis markers.The coverage rate of hepatitis B vaccine was 71.2% to 94.3%. The number of individuals undergoing complete course of hepatitis B vaccination increased fourfold. Only 0.7% of children born after the implementation of the EPI strategy were HBV carriers.
Sutanto et al572Indonesia; community-based QTDuring the study, village midwives (n = 110) used Uniject devices, rather than the standard disposable or reusable syringes. The midwives were provided with these devices in an outreach carrier box. After they picked up these boxes the midwives were allowed to keep them under ambient conditions (27°C average, range of 25−32°C) for 1 mo. Nurses administered 10 000 sterile injections in home-based settings during the trial.Potency test of the Uniject compared to the standard injection after 1 month showed that the TT vaccine had lost 6% of its potency, while the hepatitis B vaccine had suffered a 1% drop in potency. Seroconversion rates were identical in children immunized using the Uniject vs the standard vaccine method. Total cost per child immunized using the Uniject device was US $6.57 vs US$7.19 using a standard disposable syringe at the health center.
Schoub et al568South Africa; rural setting; community- based QTAll infants born in 1989 in a self-governing region of the Transvaal were immunized according to 2 schedules: (1) early schedule = birth, 3 mo and 6 mo and (2) late schedule = 3 mo, 4.5 mo and 6 mo. Those who were not given vaccine according to any 1 of these schedules were classified as unscheduled.Only 6.6% of vaccine recipients were vaccinated according to the schedules, whereas 93.4% were given vaccines in an unscheduled manner. There was no difference in seroconversion to the surface antigen between the 2 groups.