Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Efficacy of hepatitis-B immunoglobulin and hepatitis-B vaccine in prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg. A combination of hepatitis B vaccine and immunoglobulin does not protect all infants born to hepatitis B e antigen positive mothers. Use of hepatitis B vaccine alone or in combination with hepatitis B immunoglobulin for immunoprophylaxis of perinatal hepatitis B infection. Long-term hepatitis B vaccine in infants born to hepatitis B e antigen positive mothers. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin. Double-blind randomised placebo-controlled study. Combined passive and active immunization for interruption of perinatal transmission of hepatitis B virus in Taiwan. Hepatitis B immunisation with a reduced number of doses in newborn babies and children. Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: final report of a randomized double-blind, placebo-controlled trial. Evaluation of a low dose of hepatitis B vaccine given within a childhood immunisation programme in Singapore. Prevention of hepatitis B infection in infants born to hepatitis B carrier mothers: low dosage vaccination. An efficacy trial of a mammalian cell-derived recombinant DNA hepatitis B vaccine in infants born to mothers positive for HBsAg, in Shanghai, China. Passive-active immunization in infants of hepatitis Be antigen-positive mothers. Comparison of the efficacy of early and delayed active immunization. Protective efficacy of hepatitis B vaccine without HBIG in infants of HBeAg-positive carrier mothers in Thailand. Prevention of hepatitis B virus carrier state in infants according to maternal serum levels of HBV DNA. Hepatitis B immunization in high risk neonates born from HBsAg positive mothers: comparison between plasma derived and recombinant DNA vaccine. Efficacy and safety of recombinant hepatitis B vaccine in infants born to HBsAg-positive mothers. Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years. Hepatitis B immunization in high risk neonates born from HBsAg and HBeAg positive mothers: comparison of standard and low dose regimens. Results of vaccinated infants born to HBsAg-positive mothers with different hepatitis B vaccines and doses. Long-term efficacy of active postexposure immunization of infants for prevention of hepatitis B virus infection. United States-People's Republic of China Study Group on Hepatitis B. Immune response to hepatitis B vaccine in infants and newborns: control trial in an endemic area (Senegal). [Study on the efficacy of genetically engineered vaccines against hepatitis B for interruption of perinatal transmission]. Hepatitis B immunization of newborns according to a two dose protocol. [The vaccinal prophylaxis of hepatitis B among children born to mothers with persistent HBs-antigenemia]. Comparative study of the immunogenicity and safety of two dosing schedules of hepatitis B vaccine in neonates. A follow-up study of combined vaccination with plasma-derived and recombinant hepatitis B vaccines in infants. Hepatitis B vaccine in neonates: induction of anti-HBs immune response and interruption of maternal HBsAg transmission. Safety and immunogenicity of a recombinant hepatitis B vaccine administered to infants at 2, 4 and 6 months of age. The Kaiser-UCLA Vaccine Study Group.
A randomised blind controlled trial of hepatitis B immune globulin (HBIG) plus hepatitis B vaccine for the prevention of the perinatally transmitted HBsAg carrier state was conducted in Taipei. Infants of e-antigen-positive HBsAg carrier mothers were given HBIG immediately after birth, and then one of three schedules of vaccination. There was no difference in efficacy between the three schedules; the combined efficacy was 94%, compared with that of HBIG alone (71%) or of vaccination alone (75%). Persistent HBs antigenaemia developed in only 9 (6%) of the 159 infants receiving prophylaxis, but in 88% of the controls. Antibodies developed in all those who did not become antigenaemic and presumably will provide long-term protection from hepatitis B virus infection. HBIG should be given as soon as possible after birth and need not be given again if the infant is subsequently vaccinated. With HBIG coverage from birth, the timing of the start of vaccination does not seem to be of importance within the first month of life, but to maximise compliance and minimise costs hepatitis B vaccination should be initiated during the confinement. Combined prophylaxis of perinatal transmission of hepatitis B virus (HBV) with hepatitis-B immunoglobulin (HBIG) and hepatitis-B vaccine was investigated in 40 infants born to HBeAg positive carrier mothers. The efficacy of two combined prophylaxis schedules was compared to 78 similar infants in the control group receiving no treatment, by following the HBV markers at regular intervals up to one year of age. In both schedules, the HBIG and HBV vaccine were given at birth, followed by HBV vaccine given at 30 days and 60 days (group I) or 180 days (group II) of age. The incidence of persistent HBsAg carrier in infants born to HBeAg positive carrier mothers was significantly reduced from 92.6 percent at one year of age in the control group to zero percent (group I) and 11.5 percent (group II) in the treated groups. There was no statistical significant difference in the efficacy of these two combined prophylaxis schedules. HBIG given at birth did not interfere with infant immune response to the hepatitis B vaccine. At twelve months of age, anti-HBs could be detected in 77.8 percent of infants in group I and 89.5 percent in group II with mean titre of 621.4 and 1148.0 in group I and group II respectively. It was concluded that combined prophylaxis with HBIG and hepatitis-B vaccine immediately after birth is the best method for prevention of HBV perinatal transmission from HBeAg positive carrier mothers to their infants. In 42 infants of hepatitis B e antigen positive carrier mothers a randomised study of a low dose (5 micrograms) hepatitis B vaccine regimen starting within 24 hours of birth with or without hepatitis B immunoglobulin (0.25 ml/kg) showed that in the vaccine group 72% were antibody positive at the age of one year and in the vaccine plus immunoglobulin group 81%. In the vaccine group four of 18 infants were not protected and in those infants receiving vaccine plus immunoglobulin three of 21 were HBsAg carriers by 12 months of age. Hepatitis B vaccine either with or without concomitant HBIg did not protect all babies born of HBeAg positive mothers, from developing the HBsAg carrier status. Thus for full protection of all infants a more vigorous immunisation programme will be necessary. The efficacy of hepatitis B vaccine alone or in combination with immunoglobulin in neonates born to HBsAG positive mothers was investigated. Twenty-four infants were given three doses (at 0, 1, 2 months) of the vaccine alone, while 27 infants were given hepatitis B immunoglobulin (HBIG) and three doses of the vaccine. Fifty-eight infants born to HBsAg positive mothers who did not agree for vaccination or could not come for follow-up constituted the control group. The overall seroprotection rates (anti-HBS levels > or = 10 IU/l) were almost similar in both the groups at 6 months (81 and 76 per cent, respectively). However, the seroprotection rates in babies born to HBeAg positive mothers were better with combination of HBIG and vaccine (71 v. 57 per cent, respectively). It was also observed that seroprotection rates in babies born to anti-HBe positive mothers were even better (100 and 90 per cent in vaccine alone and combination group, respectively). No chronic carrier was detected in babies born to anti-HBe positive mothers. Neonates of hepatitis B surface antigen (HBsAg) positive and hepatitis B encoded antigen (HBeAg) positive mothers received 10 micrograms of recombinant hepatitis B vaccine at months 0, 1, 6, or 0, 1, 2, 12, with or without immunoglobulin at birth, and were followed up to the age of 8 years for HBsAg, anti-HBc, and anti-HBs. Some were boosted at month 60. The overall vaccine protection at month 12 was 96.2%. No child became a chronic carrier beyond the age of 3 years, showing that this vaccine provides immediate protection against HBsAg carriage, and long term protection against fetally acquired HBsAg. After month 60 hepatitis B serological markers without disease, indicating re-exposure to HBV, reappeared in comparable numbers among boosted and non-boosted children (5 for a total of 167 children). This vaccine provides long-term protection against hepatitis B chronic carriage and infection in high risk neonates with or without a month 60 booster. A booster at the age of 5-6 years or 11-12 years would reduce HBV infection, viral circulation and transmission, while ensuring long-term antibody persistence. Newborn infants of Chinese HBeAg-carrier mothers in Hong Kong were randomly assigned to one of four study groups. Group I was treated with 3 micrograms heat-inactivated hepatitis B (HB) vaccine at birth and at 1, 2, and 6 months thereafter, in conjunction with seven monthly HBIg injections; group II was treated according to the same vaccine schedule but received only one HBIg injection at birth; group III received only the vaccine, at months 0, 1, 2, and 6; and group IV received placebos for both vaccine and HBIg. The first set of injections was given within 1 h after birth. Comparisons were made in the 140 children who were at least six months old at the close of the trial (495 days). In all three treatment groups development of the persistent carrier state was significantly (p less than or equal to 0.0001) less frequent than in controls (2.9%, 6.8%, and 21.0% versus 73.2%). Although vaccination alone was significantly less protective than vaccination plus multiple HBIg injections (p = 0.03), the degree of protection was still remarkable. 12 months after the first set of injections 96-100% of the infants in the three treatment groups were anti-HBs positive; the geometric mean titres of anti-HBs in the three groups did not differ significantly. This indicates that even high doses of HBIg do not interfere with the anti-HBs response to the vaccine. Probable intra-uterine HB infections were observed in 3 infants. No serious side-effects were observed from the interventions, even in the babies with intra-uterine infections who had received HBIg and HB-vaccine at birth. To prevent development of the persistent HBsAg carrier state, and thereby the consequent chronic liver disease and/or primary carcinoma of the liver, HB vaccine and HBIg should be administered as soon as possible after birth to all newborn infants at risk of perinatal hepatitis B infection. We attempted a clinical trial to interrupt transmission of hepatitis B virus (HBV) infection from hepatitis B surface antigen (HBsAg) positive and hepatitis Be antigen (HBsAg) positive mothers to their infants in Taiwan. Screening of 5,595 pregnant women revealed that 856 (15.3%) were HBsAg positive. Three hundred and sixty-one (42.2%) of the HBsAg positive pregnant women were HBeAg positive. Infants born to HBsAg and HBeAg positive mothers were randomized into 3 groups to receive the HBV vaccine alone or combined with hepatitis B immune globulin (HBIG). HGV vaccine was given at 2, 6, and 10 weeks after birth. Group I received HBV vaccine alone while Group II received HBV vaccine in combination with HBIG at birth and group III received HBV vaccine plus HBIG at birth and again at one month old. Group IV constituted the control group when their parents refused vaccination. At 6 months of age, the HBV carrier rate was 23.7% (9/38) in Group I, 11.1% (4/36) in Group II, and 5.3% (2/38) in Group III infants. Compared with 90% of infants who became HBV carriers in the control group (Group IV), the efficacy of HBV vaccination in preventing HBV infection among these high risk infants at the 6th month was 73.7% in Group I, 87.7% in Group II, and 94.1% in Group III. The antibody to HBsAg (anti-HBs) positivity rate in sera of Group I, II, III infants at 6 months of age was 79.0%, 88.9% and 94.7%, respectively. These initial results indicate that combined passive and active immunization is efficacious in interrupting perinatal transmission of HBV infection. 74 healthy babies born to mothers positive for hepatitis B surface antigen (HBsAg) were randomly divided at birth to receive either HB immunoglobulin and 2 doses of HB vaccine 2 months apart, or HB immunoglobulin and 3 doses of HB vaccine 1 month apart. 80 healthy babies born to HBsAg, anti-HBs, and anti-HB core (c) negative mothers were randomly divided at birth to receive either 2 doses of vaccine 2 months apart or 3 doses 1 month apart. The seroconversion rates and the geometric means of anti-HBs titres were lower in both groups of babies given 2 doses of vaccine than in the groups given 3 doses. 60 pairs of children at risk, aged 1 to 12 years and HBsAg, anti-HBs, and anti-HBc negative, were randomly divided to receive either the 2-dose regimen or the 3-dose regimen. The seroconversion rates and the geometric means of anti-HBs titres were satisfactory in both groups. A randomized double-blind, placebo-controlled efficacy trial of hepatitis B immune globulin (HBIG) for prevention of the mother-to-infant transmitted HBsAg carrier state was conducted in Taiwan where the carrier rate in the general population is 15 to 20%. HBIG was given immediately after birth to infants of e antigen positive HBsAg carrier mothers, and all infants were followed for at least 15 months. Among 61 placebo recipients, the carrier rate was 92%; compared with 26% among 57 infants who received 0.5 ml HBIG at birth, 3 months, and 6 months, and 54% among 67 infants who received a single 1.0 ml dose of HBIG at birth only. Efficacy was 71 and 42%, respectively, for the two treatment schedules. The most common response of HBIG-treated infants was passive-active immunization which was 27% in the single-dose group and 61% in the three-dose group. Some of the infants who became carriers were probably infected as HBIG protection waned, and we expect that higher efficacy can be achieved by hepatitis B vaccine in conjunction with HBIG. The feasibility of introducing low dose (5 micrograms) hepatitis B (HB) virus vaccination at birth and again 1 and 2 months later as part of an existing primary immunisation programme of childhood, was assessed in 662 healthy newborn Singapore children. The vaccine (B-Hepavac, Menck, Sharp and Dohme) was given to three neonatal groups: those born to HB surface antigen (sAg)-negative mothers, HBsAg-positive/HBeAg-positive mothers and HBsAg-positive/HBeAg-negative mothers. A dose of 5 micrograms was compared in a randomised study with the more usual 10 micrograms dose given at the same intervals. Neonates born to HBsAg-positive/HBeAg-positive mothers were also given hepatitis B immunoglobulin (HBIg) at birth. The 5 microgram dose of vaccine was as immunogenic as the 10 microgram dose in all three groups of children studied. At 1 year, anti-HBsAg seroconversion among infants of antigen-negative mothers was 95.8% for the 5 microgram dose and 91.9% for the 10 microgram dose. Suppression of anti-HBsAg formation was not seen even when maternal anti-HBsAg was present or HBIg given. Among infants born to HBsAg-positive/HBeAg-positive mothers, passive plus active immunisation was 100% protective at doses of 5 micrograms and 10 micrograms vaccine in the newborns who were HBsAg-negative at 24 h. Seroconversion after both the 5 and 10 microgram doses of vaccine was reduced, however, to 88% in each group of infants who were already HBsAg-positive at 24 h of age. Overall, passive plus active immunisation as well as HB vaccine alone (5 micrograms dose), given within the existing but expanded primary immunisation programme of childhood, was effective in preventing infection and the chronic carrier state in newborns exposed to risk of HB virus infection during infancy. Two groups of newborn infants born to HBeAg positive carrier mothers were given HBIG (200 IU) immediately after birth. Subsequently, at age 2 days and at 1, 2 and 12 months, the first group received 5 microgram and the second group 2 microgram of HBV vaccines. There was no significant difference in the anti-HBs seroconversion rate (SR), and the protective efficacy rate (PER) at the age of 13 months in either group. The SR and PER of group 1 were 91.7% and 90.18%, and group II were 92.9% and 91.01%, respectively. Although the significant differences were observed in the geometric mean titers of anti-HBs in group I (526.3 mIU/ml) and group II (371.4 mIU/ml), both were above the protective level. The immune responses to the reduced dosage of HBV vaccines are satisfactory in preventing HBV in the newborn infants of HBeAg positive carrier mothers. We conducted a randomized, double-blind clinical trial of an experimental mammalian cell-derived DNA hepatitis B vaccine (Betagen, Connaught Laboratories Ltd, Toronto, Canada) to determine its efficacy in infants born to mothers who were carriers of hepatitis B surface antigen (HBsAg). Four groups of 55 infants received injections as follows: (1) a licensed plasma-derived vaccine (Lanzhou, Lanzhou Institute for Biological Products, Lanzhou, People's Republic of China), 20 micrograms; (2) Betagen, 20 micrograms; (3) Betagen, 20 micrograms+hepatitis B immune globulin (HBIG); and (4) Betagen, 10 micrograms+HBIG. Vaccine injections were given at birth and at 1 and 6 months and HBIG was given at birth. The vaccines were compared to a historical placebo control group. The efficacy of Betagen alone was 82.6% compared to 51.0% for the Lanzhou. Efficacy of Betagen increased with the concomitant use of HBIG. No infants who were HBsAg negative at birth and/or were born to hepatitis B e antigen (HBeAg) negative mothers became carriers. The rate of HBsAg in infants receiving Betagen alone, and born to mothers who were HBeAg positive, decreased from 60% at birth to 20% by the ninth month, compared to 62.5% and 50% (respectively) for Lanzhou. The percentage of infants with protective levels of antiHBs was significantly higher for Betagen alone than for Lanzhou, but the geometric mean titre of antiHBs for responders was not significantly different. We have shown that Betagen alone is highly efficacious in preventing the development of hepatitis B in infants born to mothers who are carriers of HBsAg and is also highly effective in reducing the carriage of HBsAg in infants who are HBsAg positive at birth and/or born to HBeAg positive mothers. To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth.
                Randomized study of infants born to mothers positive for hepatitis B surface antigen (HBsAg) and hepatitis Be antigen (HBeAg).
                Three large city hospitals and one rural area providing prenatal care and obstetric services.
                Eighty neonates of HBsAg- and HBeAg-positive carrier mothers received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine (10 micrograms) at 0, 1, 2, and 11 months of age (group A) or at 3, 4, 5, and 11 months of age concomitant with diphtheria, pertussis, tetanus, and polio immunization (group B). A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months.
                Blood samples were collected at 0, 3, 6, 11, and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg. Follow-up visits were scheduled annually up to 5 years of age.
                Eight infants were excluded from analysis. During the study period, six children became HBsAg carriers, three in each group, which corresponds to a 5-year incidence of infection of 9% and 8% for groups A (three of 35) and B (three of 37), respectively. Subclinical infections (persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc) were encountered in another eight infants (four in each group).
                Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age. The primary objective of this study was to estimate the efficacy of a recombinant hepatitis B vaccine (H-B-VAXII) in preventing chronic hepatitis B infection when given alone without concomitant hepatitis B immune globulin (HBIG) to healthy Thai infants born of HBeAg-positive carrier mothers. The infants received a 0.5 ml (5 micro g HBsAg) intramuscular injection of H-B-VAXII either at birth, 1, and 6 months of age (Schedule A) or at birth, 1, 2, and 12 months of age (Schedule B). Blood drawings for the determination of hepatitis B virus (HBV) serologic markers were scheduled 4, 9, and 13 months following the initial dose of vaccine. At 13 months, 5 (10%) of 50 infants vaccinated on Schedule A and 7 (14.9%) of 47 infants vaccinated on Schedule B had experienced chronic HBV infection. Based on an expected infection rate in unimmunized infants of either 70 or 90%, the overall efficacy for both schedules combined was estimated to be 82.3% (95% CI: 70.6, 90.6) or 86.2% (95% CI: 77.1, 92.7), respectively. Corresponding schedule-specific estimates were for Schedule A: 85.7% (95% CI: 68.8, 95.3) or 88.9% (95% CI: 75.8, 96.3) and for Schedule B: 78.7% (95% CI: 59.6, 91.1) or 83.4% (95% CI: 68.6, 93.1). These results suggest that in areas of high endemicity, where mothers may not always be screened for HBV infection, routine vaccination of infants at birth with a course of hepatitis B vaccine alone should be highly protective, even for very high-risk infants of HBeAg-positive mothers. 235 infants of HBeAg-carrier mothers in Hong Kong were assigned to four study groups. Groups I, II, and III received hepatitis-B (HB) vaccine at birth and at 1, 2, and 6 months. Group I also received seven monthly injections of HB immunoglobulin (HBIg), and group II received one HBIg injection at birth. Group III received vaccine only and group IV received placebo for both vaccine and HBIg. At the age of 3 years, all infants of the three treatment groups were significantly protected against the HB virus (HBV) carrier state compared with the placebo group (p less than 0.0001); the protective efficacy rates in groups I, II, and III were 87%, 80%, and 65%, respectively. At all times, group I was significantly better protected than group III. In groups III and IV, infants of mothers with serum HBV DNA levels of 5 pg/ml or above were at a significantly higher risk of acquiring the HBV carrier state than those whose mothers had HBV DNA levels below 5 pg/ml. This difference was not significant in groups given HBIg. Of the 183 infants who initially escaped HBV infection, 73 (40%) had transient and 8 (4%) chronic HBV infection between 6 and 36 months. Vaccinated infants who had actively formed anti-HBs remained well protected against the HBV carrier state. However, infants in groups I and II with no active anti-HBs response to vaccine became at risk for the HBV carrier state when the passively acquired anti-HBs antibodies had disappeared. HBIg should be included in HB vaccination schedules for all infants of HBeAg-positive mothers. A half dose recombinant hepatitis B vaccine (HBVax II, MSD, 5 micrograms) was investigated for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers as compared to the half-standard dose regimen of plasma derived hepatitis B vaccine (HBVax, MSD, 10 micrograms). Forty infants born to carrier mothers were given hepatitis B immune globulin (HBIG) 100 IU intramuscularly immediately after birth, combined with either the recombinant or plasma derived hepatitis B vaccine. The infants were randomly divided into two groups of 20 infants each. The plasma derived vaccine (10 micrograms) was given to group I, while infants in group II received the recombinant vaccine (5 micrograms) at birth, 1 and 6 months of age. There were no statistically significant differences in the efficacy and the seroconversion rate of these two combined prophylaxis regimens. The protective efficacy rate of both kinds of HBV vaccine was found to be 94.6 and 89.2 percent in group I and group II respectively. At twelve months of age, the anti-HBs seroconversion rates were 95.0 percent in group I and 84.2 percent in group II. However, the geometric mean titres in group I (179.55 mIU/ml) was significantly higher than those in group II (42.2 mIU/ml) but the anti-HBs titre was still above protective level (10 mIU/ml) in most of the infants.(ABSTRACT TRUNCATED AT 250 WORDS) Infants born to HBsAg-positive women were randomly assigned to receive either the plasma-derived hepatitis B vaccine or the yeast-derived recombinant hepatitis B vaccine within 12 h of birth, simultaneously with HBIg. The second and third doses of both vaccines were given at 1 and 6 months of age respectively. Two hundred and twenty-two infants received two doses, and 80 infants received three doses of either vaccine. Five infants were found to be HBsAg-positive at 6 months of age. Four of these infants had received the plasma vaccine and the remaining infant the recombinant vaccine. Anti-HBs was present in all the HBsAg-negative infants at 6 months of age. The titres of anti-HBs were similar in both groups of infants who had received either the plasma or the recombinant hepatitis B vaccine. No major adverse reactions were reported with either vaccine. The preliminary results from this study suggest that the yeast-derived recombinant hepatitis B vaccine is safe, immunogenic and at least as effective as the plasma-derived hepatitis B vaccine in preventing the HBsAg carrier state in infants born to HBsAg-positive women. In a randomized, controlled trial, 105 healthy full-term infants born to HBsAg and HBeAg positive mothers received three doses (at 0, 1 and 6 months) of either a new recombinant hepatitis B vaccine (Hepavax-Gene) or Engerix-B. Both groups were also given hepatitis B specific Hepa-big immunoglobulin (HBIG) within 24h of birth. Levels of antibodies to hepatitis B surface antigen (anti-HBs) were assessed on days 30, 60, 210, 360, and 2 years post-vaccination. Efficacy and immunogenicity and safety of the two vaccines were not significantly different; both vaccines achieved >94% seroprotection within 360 days. At 2 years, only one subject (1.9%) in the Hepavax-Gene group and two subjects (3.9%) in the Engerix-B group were HBsAg positive. No serious adverse events (AEs) were observed in either group. A reduced dose of plasma derived hepatitis B vaccine (Hevac B) was tested for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers. Forty newborn infants born of these mothers were given hepatitis B immune globulin (HBIG) 100 IU intramuscularly immediately after birth, combined with either standard or reduced doses of HBV vaccine. The infants were divided into two groups of 20 infants each. The standard dose of HBV vaccine (5 micrograms) was given to group I, while infants in group II received reduced dose (2 micrograms) at birth and at 1, 2 and 12 months of age. There was no statistically significant difference in the efficacy and antibody responses of these two combined prophylaxis regimens. The protective efficacy rate of HBV vaccine was found to be 94.0 and 93.2 percent in group I and group II, respectively. At twelve months of age, the anti-HBs seroconversion rates were 80.0 percent in group I and 86.7 percent in group II, with geometric mean titres of 84.57 mlU/ml and 78.56 mlU/ml, in group I and group II, respectively. One month after a booster at one year of age, anti-HBs could be detected in 86.7 percent of the infants in both groups. The geometric mean titres were 429.04 and 664.81 mlU/ml, in group I and group II, respectively. Anti-PreS2 antibody was detected in high titre as early as 4 months after the first dose of HBV vaccine, with a geometric mean titre of 116.30 mlU/ml and 107.97 mlU/ml, in group I and group II, respectively.(ABSTRACT TRUNCATED AT 250 WORDS) Seventy-eight infants born to HBsAg-positive women were randomly assigned to receive either the plasma-derived vaccine or 0.5 ml (10 micrograms HBsAg) yeast-derived recombinant hepatitis B vaccine within 24 hours of birth, simultaneously with hepatitis B hyperimmunoglobulin. In 67 infants who received the plasma-derived vaccine, one of the doses of 0.5 ml (25 micrograms HBsAg) was used randomly. In all of the infants, the second and third doses of both vaccines were given at one and two months of age, respectively. The booster doses were given at 12 month of age in all of the infants. These vaccinated infants were followed up until 13 months of age. There were differences in the seroconversion rates with different vaccines and doses. The recipients of the half-dose of plasma-derived vaccine showed lower seroconversion rates than the others, and the newborns in this group showed more seronegativity (13.2%) than the others (p < 0.05). The lowest anti-HBs geometric mean titers (GMTs) were obtained in newborns vaccinated with Hevac B 0.5 ml. Sixty percent of the anti-HBs GMTs in this group were under 100 mlU/ml. There were statistically significant differences between males and females in anti-HBs seronegativity rates, with males having lower anti-HBs GMTs than females. The difference was particularly significant among male newborns vaccinated with a half-dose of plasma-derived vaccine. Perinatal transmission of hepatitis B virus (HBV) contributes to the high prevalence of chronic infection in China and many other countries. In a placebo-controlled trial among 166 infants, the 12-month efficacy of active postexposure prophylaxis to prevent chronic perinatal HBV infection varied by vaccine (range, 45%-89%). In a 5-year follow-up study, 2 additional infants became chronically infected with HBV, and the efficacy of active prophylaxis was estimated to be 38% and 72% for the two vaccines at 5 years. In addition, 80% of immunized infants continued to have protective levels of antibody at the end of 5 years. However, among 27 infants who received passive-active immunoprophylaxis with high-dose hepatitis B immune globulin, only 60% (11/19) had protective antibody levels. These data indicate that active postexposure immunization initiated soon after birth continues to provide protection during early childhood when there is a high risk of chronic HBV infection. In 1978 it was suggested that hepatitis B (HB) vaccine should be used to prevent the early hepatitis B surface antigen (HBsAg) carrier state in children. Immunization was effected by 3 injections of HB vaccine at one-month intervals followed by a booster injection after one year. Children in a control group were immunized with DT-polio vaccine according to the same schedule. The anti-HBs response of the children to HB vaccination was studied in relation to their hepatitis B virus (HBV) serum markers prior to immunization. Of the seronegative children, 70.5% responded to immunization after 2 injections of 5- g doses of HB vaccine and 94% after the third injection. The efficacy of the vaccine was demonstrated by comparison of HB events after one year in 309 seronegative children immunized with HB vaccine and 252 seronegative children immunized with DT-polio vaccine, and after two years in 101 and 119 children, respectively. The incidence of the HBsAg carrier state was reduced by 80% in susceptible children. In order to eliminate the perinatal transmission occurring in newborns with HBsAg-positive mothers, a study of immunization at birth has been instituted. A total of 86 newborns responded to the vaccination as well as older children, irrespective of the HBV status of their mothers. After one year, the incidence of the HBsAg carrier state was reduced by 80%. In Africa, immunization teams have a limited amount of time to devote to each rural community. The immunogenic effect of 2 doses of HB vaccine given at an interval of 2 or 6 months has therefore been investigated. All were given a booster dose one year after the first injection of vaccine. No difference was observed in the seroconversion rate or in the anti-HBs titres as between the two protocols. These results demonstrate that 2 doses of 5 micrograms of HB vaccine are sufficient to obtain a high immunogenic effect in infants. In addition, an investigation was carried out on the immune response to HBsAg and tetanus toxoid antigen when administered simultaneously to children as HB vaccine and DT-polio vaccine. The immune response was at least equal to that observed after administration of these vaccines separately. The infectivity rate of newborn babies who had been borne from HBsAG(+), HBeAg(+) and anti-HBc(+) mothers was very high (85%). 142 babies born in the hospital were divided into three groups, in this study. In the group 1, 57 babies were inoculated with 20 micrograms recombinant DNA vaccinia vaccines against hepatitis B. The injections were given at newborn, 1 month, and 6 months, respectively. In group 2, 41 babies were inoculated with 20 micrograms genetic engineering vaccines against hepatitis B at same time were intervals as group 1. In group 3, 44 newborn babies were inoculated with 10 micrograms as same vaccines as group 2 HBIG plus 1ml (200 U/ml), at same time intervals as group 1. The immune pretection rates of newborn babies in three groups were 88.2%, 85.9% and 100%, respectively. The anti-HBs pasitive conversion rates were 82%, 86% and 98%, respectively. The group 3 was compared with group 1 and 2. Statistical analysis showed the significant differences (P < 0.05). The result showed the immune program of group 3 was superior to that of group 1 and 2, and none of the 44 babies in group 3 were infected. The efficacy of immunization by genetic engineering vaccines were superior to that of blood-derived vaccine. The genetic engineering vaccines against hepatitis B would be more useful for interruption of perinatal transmission of HBV. Experimental hepatitis B immunization trial in newborns was carried out in Burundi. Newborns were randomly divided into vaccine and control groups. Vaccinated newborns were given two injections of hepatitis B vaccine: one at birth and another 2 months later. A booster dose was given at 12 months of age. Results obtained show that two months after the second dose of HB vaccine, 96.8% of the vaccinated babies had anti-HBs; at the age of one year this figure had fallen to 83.8%. Six months after the booster dose, 95.6% were anti-HBs positive, with a geometric mean titre of 214 mIU ml-1. The anti-HBs responses in these infants was compared to those observed in previous studies performed in Senegal in infants (same protocol) or in newborns (3 dose protocol). The anti-HBs responses were lower in terms of mean titre values in neonates who received the two dose protocol than in older children and in neonates who received three doses at one month intervals. Vaccine efficacy was monitored during a two year period in neonates both immunized and nonimmunized. Protective efficacy was found to be 100% if considering HBsAg positive events and 75% if considering all HBV events (HBsAg and/or anti-HBc positive). In Uzbekistan and Moldova 542 children born of HBsAg carriers were immunized against hepatitis B (with vaccine Engerix B according to the immunization schedule of 4 injections). Anti-HBs antibodies in protective titers were detected by EIA and RIA techniques in 76.7% of children aged 4-5 months after the 3rd injection, in 95.7% of children aged 15-16 months and in 90.0% of children aged 2-2.5 years after the 4th (booster) injection. In the control group (117 nonimmunized children born of HBs carriers) observed during the same period anti-HBs antibodies were detected significantly less frequently (in 7.3%, 11.6% and 12.9% of these children respectively). 1-2 months after the course of immunization was completed 74.1% of the immunized children had high anti-HBs antibody titers (exceeding 1000 IU/ml) with their subsequent decrease by 2-2.5 years of age. In the control group these figures were 27.1% and 29.0% respectively. The index of immunization effectiveness obtained by the comparison of the hepatitis B morbidity rates in both groups was 7.8. No postvaccinal complications were registered. Healthy Egyptian neonates born to hepatitis B surface antigen (HBsAg)-seronegative mothers were randomly enrolled in one of three vaccination schedules. A dose of 2.5 micrograms of recombinant HB vaccine was given at birth, two, and six months of age (group A) or two, four, and nine months of age (group B). These two groups and a third control group (group C) also were given the other routine childhood vaccines (BCG, DPT, polio, and measles). Blood samples were taken one month after the third vaccine dose in groups A (seven months of age) and B (10 months of age), and a second follow-up blood sample was taken at the age of 18 months for all three groups. Sera were tested for HBsAg and antibody to hepatitis B core antigen, and quantitatively for antibody to hepatitis B surface antigen (anti-HBs) using commercial enzyme immunoassay kits. The vaccine was well tolerated and side effects were limited to local soreness, redness, or temporary swelling. Among 590 infants who were followed-up, good (51-300 mIU anti-HBs/ml) or excellent (> 300 mIU/ml) immune responses occurred in 85% of the infants in group A and in 96% in group B. Geometric mean titers of anti-HBs at the first and second follow-up were 306 and 55 mIU/ml in group A, and 1,492 and 147 mIU/ml in group B. The recombinant HB vaccine is safe and immunogenic when given in three doses of 2.5 micrograms in either regimen, but delay of the booster dose of the vaccine until nine months after birth produced a higher immune response. This study was aimed to evaluate the efficacy and immunogenicity of combined hepatitis B vaccination with plasma-derived vaccine (PDV) and recombinant vaccine (RV). A total of 329 infants was recruited, including 224 high-risk infants born to hepatitis B e antigen-positive mothers and 105 low-risk infants born to hepatitis B e antigen-negative mothers. The high-risk infants received four doses of hepatitis B vaccine at 0, 1, 2 and 12 months of age with five different schedules. Group A1 and A2 infants were vaccinated with PDV as the first dose and RV (SB vaccine for group A1, MSD vaccine for group A2) as the remaining three doses. Group B1 and group B2 infants were vaccinated with PDV as the first two doses and RV (SB vaccine for group B1, MSD vaccine for group B2) as the remaining two doses. Group C infants received four doses of PDV. Low-risk infants were vaccinated with PDV at birth, and RV at 1 and 6 months of age (group D1, using SB vaccine; group D2, using MSD vaccine). At completion of vaccination schedules, 20 of 224 high-risk infants (9%) were positive for hepatitis B surface antigen. The overall protective efficacy was 90%. Hepatitis B surface antibody (anti-HBs)-positive rate ranged between 94 and 100% among the remaining infants. The protective efficacy and immunogenicity were similar among groups except that the mean level of anti-HBs in group C, D1 and D2 infants tended to be lower than that of the other four groups. To ensure an optimal immune response, four doses of vaccine are recommended in high-risk infants when two types of vaccine are to be used in combination. nan A recombinant hepatitis B vaccine was administered to over 5000 infants in a prospective, randomized and blinded study. Infants were given either recombinant hepatitis B vaccine (Engerix-B, SmithKline Beecham Pharmaceuticals, 10 micrograms dose-1) or a Haemophilus influenzae type b (Hib) conjugate vaccine at 2, 4 and 6 months of age simultaneously with diphtheria-tetanus-pertussis and oral polio vaccines. Adverse reactions were ascertained by parental reports and interviews, and review of medical records. Blood specimens collected from 269 infants given hepatitis B vaccine were assayed for antibody to hepatitis B surface antigen (anti-HBs) by enzyme immunoassay. Infants given hepatitis B vaccine experienced low rates of adverse reactions that were similar or lower than the rates in infants given Hib conjugate vaccine. The geometric mean anti-HBs concentrations were 9.6 mIU ml-1 after one dose, 333 mIU ml-1 after two doses and 1812 mIU ml-1 after three doses (99% had levels > or = 10 mIU ml-1). Antibody responses to diphtheria and tetanus toxoids were unaffected by simultaneous administration of hepatitis B or Hib conjugate vaccine. Engerix-B vaccine was safe and immunogenic when given with other routine childhood immunizations at 2, 4 and 6 months of age, and should provide long-term protection against hepatitis B virus infection.
Vaccine, hepatitis B immunoglobulin, and vaccine plus hepatitis B immunoglobulin prevent hepatitis B occurrence in newborn infants of HBsAg positive mothers.