Prevention of hepatitis B infection by hepatitis B immune globulin in infants born to mothers with acute hepatitis during pregnancy

Eleven infants born to mothers with acute hepatitis B during the third trimester of pregnancy who were hepatitis B surface antigen-positive at delivery were treated with hepatitis B immune globulin within 24-48 h of birth. Five infants received one dose of hepatitis B immune globulin and 6 infants received a second dose at 1 mo of age. During the average 12.5-mo follow-up period, only 1 of 11 (9%) treated infants became hepatitis B surface antigen-positive and this individual developed acute hepatitis B at 9.5 mo of age and recovered. Twenty-four infants born to mothers with acute hepatitis B during the third trimester of pregnancy who were untreated served as historical controls. Of these, 17 (71%) showed evidence for hepatitis B infection and 15 (62.5%) became chronic hepatitis B virus carriers. This study shows that administration of hepatitis B immune globulin to infants born to mothers with acute hepatitis B is effective in preventing perinatal transmission of the hepatitis B virus. With the availability of the hepatitis B virus vaccine, the current recommendation is to give hepatitis B immune globulin to such infants within 24 h of birth, followed by three doses of the hepatitis B virus vaccine beginning soon after birth, and again 1 and 6 mo later.     

Efficacy of hepatitis B immune globulin in prevention of perinatal transmission of the hepatitis B virus

An efficacy trial of hepatitis B immune globulin in the prevention of perinatal transmission of hepatitis B virus infection was conducted in Los Angeles. Ten infants born to hepatitis B surface antigen (HBsAg)-and hepatitis B e antigen (HBeAg)-positive carrier mothers as well as 4 infants born to mothers with acute hepatitis B in the third trimester of pregnancy received hepatitis B immune globulin without randomization. Twenty infants born to HBsAg- and antibody to hepatitis B e antigen (anti-HBe)-positive carrier mothers were randomized to receive hepatitis B immune globulin or a placebo. All infants were followed for up to 18 mo. Four infants (2 born to HBeAg carrier mothers, 1 to an anti-HBe carrier, and 1 to a mother with acute hepatitis) became HBsAg-positive carriers, whereas another infant, whose mother was an HBeAg carrier, developed a transient anicteric hepatitis B infection. All infants who became infected did so after 9 mo of age as hepatitis B immune globulin protection waned. In infants born to HBsAg-positive carrier mothers, active immunoprophylaxis with the hepatitis B vaccine must be used in conjunction with hepatitis B immune globulin.     

Prevention of perinatal transmission of hepatitis B virus: a comparison between the efficacy of passive and passive-active immunization in Korea

In a study to compare the prophylactic efficacy of passive and passive-active immunization against hepatitis B virus (HBV) among newborn infants of HBV carrier mothers positive for hepatitis B e in Korea, both regimens resulted in effective protection against development of hepatitis B surface antigen (HBsAg): 10 of 12 recipients of hepatitis B immune globulin (HBIG) and 25 of 29 recipients of HBIG and vaccine during nine months of follow-up. Among untreated controls in the same population just before the present study, 12 of 16 developed HBsAg within nine months of birth. Seven recipients of HBIG and vaccine and four untreated infants who had HBsAg in their blood at birth were excluded. The declining antibody levels in infants who received only HBIG as compared with the rising antibody levels in infants who received HBIG followed by three doses of HBV vaccine suggest that long-term protection will be seen only in the latter group.     

Immunoprophylaxis of infection with hepatitis B virus in infants born to hepatitis B surface antigen-positive carrier mothers

Infants born to carrier mothers positive for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) received 5 micrograms of hepatitis B virus (HBV) vaccine on four occasions. Group 1 received vaccine only, group 2 received vaccine plus hepatitis B immune globulin (HBIG) at birth, and group 3 received vaccine plus HBIG at birth and at one month. Infants born to HBeAg-positive mothers (group 4) received a reduced dose of vaccine (2.5 micrograms) on three occasions as well as HBIG at birth. As compared with 78.4% of the control group (infants whose parents refused vaccination) who became chronic HBV carriers at the age of 14 months, the protective efficacy rate of vaccination was 75.3% in group 1,85.5% in group 2,89.7% in group 3, and 87.2% in group 4. HBV vaccine (5 micrograms) was also given to infants born to HBsAg-positive, HBeAg-negative mothers on four on four occasions. The antibody response to HBsAg in vaccine recipients was 12% after the first dose, 44% after the second dose, and 75% and 100% at six months and 1.5 years of age, respectively.     

Five years of vaccination campaign against hepatitis B in Italy in infants of hepatitis B surface antigen carrier mothers

The programme of the current vaccination campaign against hepatitis B in Italy considers the newborn of hepatitis B surface antigen (HBsAg) positive mothers to be high priority. Pregnant women are screened for HBsAg during the third trimester of pregnancy. All newborn of HBsAg positive women, regardless of the mother's status of hepatitis Be antigen (HBeAg), are given a single dose of hepatitis B immune globulin within 24h after birth and the first dose of hepatitis B vaccine within 7 days after birth. During the period 1984-1988 the percentage of pregnant women screened for HBsAg increased from 32% in 1984 to 71% in 1988 (P less than 0.001). The prevalence of HBsAg positive mothers was stable, ranging from 2.2% to 2.5%, but with wide regional differences (range 0.3%-6.4%). The screening compliance of pregnant women has been significantly better (P less than 0.01) in regions at a lower (less than 5%) HBsAg carrier rate. The percentage of children born to carrier mothers, who received active plus passive immunization, ranged from 75% to 85%. The number of infants immunized as percentage of those expected to be immunized (applying the observed prevalence of carrier mothers to the total number of deliveries by year) increased from 29% in 1984 to 62% in 1988 (P less than 0.01). No serious side effects were reported.     

Combined passive and active immunization for interruption of perinatal transmission of hepatitis B virus in Taiwan

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.     

Failure of immune serum globulin to prevent hepatitis B virus infection in infants born to HBsAg-positive mothers.

Twelve infants, born to mothers with hepatitis B virus infection, were inoculated within 7 days of birth with immune serum globulin containing antibody to hepatitis B surface antigen (HBsAg) titers of 1:32 to 1:64 as measured by passive hemagglutination. Six of nine infants (66.7%) born to HBsAg-positive carrier mothers became HBsAg-positive within 3 mo of age. In addition, two of three treated infants born to mothers with acute hepatitis B during the delivery period also developed HBsAg. The hepatitis e antigen was detected in four of five carrier mothers and in two mothers with acute hepatitis, whose infants subsequently became HBsAg positive. In addition, hepatitis B-specific DNA polymerase activity was detected in the seven HBsAg-positive mothers who transmitted the virus to their infants. All eight infants have remained persistently HBsAg positive. Thus, the immune serum globulin containing low-titer antibody to HBsAg is not protective when given to infants born to HBsAg carrier mothers or to mothers with acute hepatitis B during the delivery period.     

Prevention of perinatal transmission of hepatitis B virus (HBV) to children of e antigen-positive HBV carrier mothers by hepatitis B immune globulin and HBV vaccine

The efficacy of hepatitis B immune globulin (HBIG) with two hepatitis B virus (HBV) vaccines was investigated for prevention of vertical transmission of HBV to infants born to e antigen-positive HBV carrier mothers. Infants received 150 mg of the F(ab')2 fraction of HBIG intravenously within 2 hr of delivery, and serum titers of antibody to hepatitis B surface antigen (anti-HBs) were kept greater than 1:4 (passive hemagglutination) by subcutaneous injection of HBIG thereafter. HBV vaccine was started three or six months after delivery. Of 50 infants older than nine months, 49 were actively immunized against hepatitis B surface antigen. Vaccine containing alum adjuvant immunized the infants in a shorter period than did vaccine without adjuvant. Serum titers of anti-HBs of actively immunized infants were well maintained afterward. None of the infants treated with HBIG and HBV vaccine was positive for serum antibody to hepatitis B core antigen at 12 months of age. No side effects were observed.     

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

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.     

Hepatitis B infection in a large municipal obstetrical population: characterization and prevention of perinatal transmission

We have previously described a large municipal obstetrical population in which the carriage rate of hepatitis B (HBV) is 1.2%. The present study was undertaken to determine the effectiveness of our immunoprophylaxis regimen (hepatitis B immune globulin at 36-72 h, hepatitis B vaccine at 36-72 h, 1 month and 6 months) in eliciting protective antibody to hepatitis B surface antigen (anti-HBs) in the infants of these women, the rate of perinatal transmission of HBV in this population prior to vaccination, the prevalence of anti-hepatitis delta antibody (anti-HD), and the prevalence of liver disease in our hepatitis B surface antigen-positive (HBsAg+) population. Four hundred eleven infants of HBsAg+ women were born during the 33-month study period. Of these, only 64 (15.6%) completed the vaccine series and returned for testing at 12 months. Sixty of the 64 had anti-HBs, and one (1.6%) had become HBsAg+. Eighty-nine older siblings of the immunized infants were tested, and 17 (19%) were HBsAg+. Of 54 mothers and eight siblings who were HBsAg+, none had anti-HD. Serum alanine aminotransferase (ALT) levels were normal in 53 of 54 HBsAg+ mothers tested. These data demonstrate 1) reduction of perinatal transmission of HBV from 19% to 1.6% using our protocol, 2) absence of hepatitis delta infection in this population, and 3) high prevalence of asymptomatic carriage of HBV, rather than clinically significant liver disease, in this population. It is imperative to improve compliance in order to maximize the effectiveness of immunoprophylaxis for newborns of HBsAg+ mothers.     

A retrospective study of hepatitis B mother‐to‐child transmission prevention and postvaccination serological test results of infants at risk of perinatal transmission in two counties of middle China

Approximately, 240 million people have chronic hepatitis B worldwide, with mother‐to‐child‐transmission (MTCT) accounting for most cases. Therefore, Henan Province, China launched a public health programme to prevent MTCT. To determine the efficacy of this health programme, a survey was carried out in Huixian and Xinan counties, which are located in northern and western Henan. All infants born in these two counties between January 1, 2013 and March 31, 2014 to a mother positive for hepatitis B surface antigen (HBsAg) were surveyed. In total, there were 438 mother‐infant pairs. A blood sample was collected from all mothers and infants and the following Hepatitis B virus (HBV) markers, antibodies, and antigens were measured: HBsAg, anti‐HBs, anti‐HBc, HBeAg, anti‐HBe, and HBV‐DNA. All mothers and 5.3% (23/438) of the infants were HBsAg positive. All infants received three doses of the hepatitis B vaccine (HepB) and the postvaccination serological test (PVST) showed that the appropriate interval for PVST may be 1‐8 months after the final HepB dose. Multivariable analysis showed that infants without a timely first and second dose of the HepB, with an HBeAg‐positive mother and mothers who had not received hepatitis B immune globulin during pregnancy were implicated in MTCT. The stratified analysis using maternal HBeAg as a marker showed that maternal HBeAg may be a strong risk factor for MTCT. To prevent MTCT in middle China, several courses of action are recommended. The first is to optimize the screening method for the mother to allow HBeAg and HBsAg‐positive mothers to receive medical treatment during pregnancy and a timely birth dose of the vaccine to all infants. Second, all infants with an HBsAg‐positive mother should be tested for anti‐HBs and HBsAg at 7‐14 months old and any anti‐HBs‐nonresponse infants should receive an additional three dosesof the vaccine.     

Selective immunisation strategy to protect newborns at risk for transmission of hepatitis B: retrospective audit of vaccine uptake

BACKGROUND: 90% of newborns infected perinatally will develop chronic hepatitis B infection with the risk of liver cirrhosis or hepatocellular carcinoma. In Switzerland, screening of all pregnant women for hepatitis B virus (HBV) has been recommended since 1983. Neonates at risk for perinatally acquired HBV are passively and actively immunised immediately after birth as well as at 1 and 6 months of age. The objective of this study was to evaluate the proportion of newborns immunised in accordance with the proposed vaccination schedule. METHODS: Patient records of 3997 mothers who gave birth to a liveborn infant during a two-year period at Zürich University Hospital were screened by computer. 128 women were identified as HBsAg positive or anti-HBc alone positive. Of 133 infants born to these mothers, complete data were available for 94 (71%). RESULTS: Immunisation was started in 88 infants (94%), but only in 78 (83%) within the first 24 hours of life. 85 (90%) received the 2nd immunisation but only 72 (77%) within the given time limit. 80 (85%) of the infants received the 3rd immunisation but only 69 (73%) within the correct time limit. In summary, only 51 (54%) of the infants at risk for HBV infection were immunised correctly (immunoglobulin within 24 hours and active prophylaxis at 0, 1 and 6 months). CONCLUSIONS: The success of the immunisation strategy following maternal screening and selective immunisation of newborns at risk for HBV infection is limited for various reasons (lack of screening results at birth, problems with correct documentation and communication). To overcome these drawbacks, selective vaccination strategy should be improved and general vaccination strategy, including infants, should be reconsidered.     

Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection

AIM:To evaluate the effects of tenofovir disoproxil fumarate(TDF)use during late pregnancy to reduce hepatitis B virus(HBV)transmission in highly viremic mothers.METHODS:This retrospective study included 45 pregnant patients with hepatitis B e antigen(+)chronic hepatitis B and HBV DNA levels>107copies/mL who received TDF 300 mg/d from week 18 to 27 of gestation(n=21).Untreated pregnant patients served as controls(n =24).All infants received 200 IU of hepatitis B immune globulin(HBIG)within 24 h postpartum and 20μg of recombinant HBV vaccine at 4,8,and 24 wk.Perinatal transmission rate was determined by hepatitis B surface antigen and HBV DNA results in infants at week 28.RESULTS:At week 28,none of the infants of TDFtreated mothers had immunoprophylaxis failure,whereas2(8.3%)of the infants of control mothers had immunoprophylaxis failure(P=0.022).There were no differences between the groups in terms of adverse events in mothers or congenital deformities,gestational age,height,or weight in infants.At postpartum week 28,significantly more TDF-treated mothers had levels of HBV DNA<250 copies/mL and normalized alanine aminotransferase compared with controls(62%vs none,P<0.001;82%vs 61%,P=0.012,respectively).CONCLUSION:TDF therapy during the second or third trimester reduced perinatal transmission rates of HBV and no adverse events were observed in mothers or infants.     

HBsAg阳性母亲所生婴儿的母婴阻断及全程接种乙型肝炎疫苗后免疫应答状态

目的 了解HBsAg阳性母亲所生婴儿的母婴阻断及全程接种乙型肝炎疫苗后免疫应答状态及变化规律.方法 对249例HBsAg阳性母亲的新生儿予以联合母婴阻断措施,并全程接种乙型肝炎疫苗,用微粒化学发光法跟踪测定婴儿生后7、12、24、36个月的HBsAg和抗-HBs水平.组间比较采用卡方检验.结果 HBsAg阳性母亲所生婴儿母婴阻断后不同时间免疫应答状态不同,7月龄婴儿无应答率为8.0%(20/249),低应答率为11.7%(29/249),强应答率为80.3%(200/249);12月龄婴儿无应答率为10.8%(13/120),低应答率为26.7%(32/120),强应答率为62.5%(75/120);24月龄婴儿无应答率14.8%(4/27),低应答率为33.3%(9/27),强应答率为51.9%(14/27),36月龄婴儿无应答率为14.3%(1/7),低应答率为28.6%(2/7),强应答率为57.1%(4/7);7月龄组与其他月龄组同等应答状态间比较,差异有统计学意义(x2=21.98,P＜0.01).强应答组婴幼儿抗-HBs效价出生7个月后出现逐渐下降的趋势,效价越高,其下降的例数越少,下降出现的时间越晚.抗-HBs效价＞1000 mIU/mL时,在36个月内下降比率为57.6%(19/33),下降高峰为24个月(57.9%,11/19);抗-HBs效价为100～1000 mIU/mL时,在36个月内下降比率为73.8%(31/42),下降高峰为12个月(54.8%,17/31).HBsAg阳性婴儿7月龄多表现为无应答状态,占全部无应答婴儿的70%(14/20,x2=128.61,P＜0.01),99%(189/191)HBsAg阴性婴儿多为强应答.HBeAg同时阳性母亲的婴儿无应答率有高于HBeAg阴性母亲婴儿的趋势,但差异无统计学意义(9.1%比5.5%,x2=0.24,P＞0.05).结论 HBsAg阳性母亲新生婴儿的母婴阻断及全程接种乙型肝炎疫苗后不同时间免疫应答状态不同,且呈动态变化;无应答状态多见于HBsAg阳性的免疫失败婴儿;HBsAg阴性婴儿大多呈强应答;HBeAg同时阳性的母亲婴儿更易呈低应答.建议完善母婴阻断后管理流程,特别是生后7个月～2年的积极随访监测.     

Combined hepatitis B immune globulin and vaccine for postexposure prophylaxis of accidental hepatitis B virus infection in hemodialysis staff members: comparison with immune globulin without vaccine in historical controls

Twenty-three staff members serving in a hemodialysis unit were exposed accidentally to needlestick contaminated with blood containing hepatitis B surface antigen and hepatitis B e antigen, as well as high levels of DNA polymerase activity (greater than 100 cpm). They received hepatitis B vaccine (20 micrograms) simultaneously with hepatitis B immune globulin (5 ml, 200 IU per ml) within 48 hr after the exposure, and the vaccination was repeated at 1 and 3 months. The protective efficacy was compared with that in a past study in the same unit in which 33 members were given hepatitis B immune globulin alone within 48 hr after the exposure to blood with similarly high levels of DNA polymerase activity. No differences were noted in age or sex between the staff members who were vaccinated and those who were not, nor were there any differences between their inocula in the titers of hepatitis B virus markers. During 12 months after the accident, only one (4%) of the 23 vaccinated members contracted hepatitis B virus infection, at a frequency significantly lower than 11 (33%) of the 33 members who did not receive vaccine (p less than 0.02). These results indicate that hepatitis B vaccine, when given in combination with hepatitis B immune globulin, is efficacious for postexposure immunoprophylaxis of accidental infection.     

Sensitivity and specificity of capillary blood HBsAg as a surrogate marker for HBeAg in pregnant women

Infants at high risk of acquiring hepatitis B virus (HBV) infection from their hepatitis B e antigen (HBeAg)-positive mothers are prime targets for early HBV immunization. The usefulness of fingerprick blood of pregnant women as a surrogate marker to identify infants who would need immunization soon after birth was evaluated. Using HBeAg from venous blood as the standard, the detection of hepatitis B surface antigen (HBsAg) by reverse passive haemagglutination in capillary blood yielded an overall sensitivity of 97% and a specificity of 96% for detecting HBeAg at a cutoff titre of 2^2.5. Pregnant women with a capillary HBsAg titre of 2^2.5 or greater are 24 times more likely to infect their babies, while the chances of transmitting HBV infection with a titre lower than the cutoff point are almost nil. When the cost of HBV vaccine eventually comes down to levels suitable for public health use, a cutoff titre of 2^2.5 is suggested in order to identify infants who should be vaccinated soon after birth.     

Poor response to HBV vaccination and strategies to enhance immunogenicity

Abstract   Hepatitis B vaccination has been proved to be effective in preventing acute and chronic hepatitis B virus (HBV) infection, fulminant hepatitis, and hepatocellular carcinoma. Approximately 5 to 15% of infants and at least 5 to 10% of most healthy adult population failed to produce protective levels of antibodies to HBV vaccination.
The main causes of poor response to HBV vaccination includes intrauterine infection, vaccine escape mutants, genetic hypo-or non-responsiveness to hepatitis B surface antigen (HBsAg) and immune compromised host.
Strategies to enhance immunogenicity to HBV vaccination are as the following: (1) overcome intrauterine or perinatal transmission by antiviral therapy for high risk pregnant women during last trimester, or immediately after birth with HBV hyperimmune globulin for the neonates; (2) higher dosage or more doses of HBV vaccine; (3) better vaccines ; (4) enhance host immune status; (5) better compliance of the vaccines.
In conclusion, current hepatitis B vaccination has been proved to be effective in controlling acute and chronic HBV infection and its complication. Yet further efforts to improve its efficacy generally and in high risk subjects and in immune compromised hosts are needed.     

Simultaneous passive and active immunization against hepatitis B: noninterference of hepatitis B immune globulin with the anti-HBs response to reduced doses of heat-inactivated hepatitis B vaccine

The effect of simultaneous administration of hepatitis B immune globulin on the antibody response to a low dose of heat-inactivated hepatitis B vaccine was investigated in 175 health care workers. Subjects were divided into four groups: Groups I and II received 3 monthly injections of a reduced dose (0.6 microgram) of a heat-inactivated hepatitis B vaccine (the usual dose being 3 micrograms) along with 500 IU of hepatitis B immune globulin simultaneously with the first injection of vaccine; Groups III and IV received the vaccine only. In addition, Groups I and III received a final booster injection with 0.6 microgram of the vaccine 8 months after the initial injection. Anti-HBs passively acquired from hepatitis B immune globulin did not interfere with the development of an active antibody response to the vaccine: the anti-HBs conversion rates were similar in persons treated with the combined regimen (89%) as in those who received the vaccine only (91%). At 3 and 5 months after the first injection, however, anti-HBs titers in the recipients of vaccine alone were slightly but statistically significantly higher than those of persons who received both hepatitis B immune globulin and vaccine; but at 8 months, this difference was no longer statistically significant. After a booster inoculation at 8 months, the geometric mean titer of anti-HBs increased 7- to 8-fold in antibody-positive vaccinees, regardless of whether hepatitis B immune globulin had been given earlier. Moreover, 6 of 13 nonresponders to the initial three vaccine injections developed anti-HBs after the booster inoculation.(ABSTRACT TRUNCATED AT 250 WORDS)     

Prevention of maternal-infant hepatitis B virus transmission by immunization: the role of serum hepatitis B virus DNA

Sera from 108 HBsAg carrier mothers at delivery and their respective offspring at birth and at 6 months of age were examined for hepatitis B virus DNA by the dot-blot hybridization technique. Hepatitis B virus DNA was detected in 83% of 88 carrier mothers who were HBeAg positive, and in 10% of 20 carrier mothers who were HBeAg negative. All five infants born to HBeAg-positive carrier mothers with hepatitis B virus DNA levels over 80 pg per 10 microliters of serum were infected by hepatitis B virus, in spite of receiving hepatitis B immunization. All 17 infants without hepatitis B immunization who were born to HBeAg and hepatitis B virus DNA-positive carrier mothers developed hepatitis B virus infection. Of 56 infants born to HBeAg and hepatitis B virus DNA-positive carrier mothers and who had received hepatitis B immunization, a higher hepatitis B virus infection rate was found in a group of infants whose sera hepatitis B virus DNA were positive (15/16, 93.8%) than in infants whose sera were negative (17/40, 42.5%) at birth (p less than 0.0005). These data suggest that the assay for hepatitis B virus DNA in sera of HBsAg carrier mothers at delivery or their infants at birth will predict the efficacy of hepatitis B immunization for prevention of maternal-infant hepatitis B virus transmission.     

Comparison of three different recombinant hepatitis B vaccines： GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India

AIM: To evaluate a low cost Indian recombinant hepatitis B vaccine GeneVac-B for its immunogenicity and safety in comparison to Engerix B and Shanvac B vaccine in high risk newborn infants born to hepatitis B surface antigen (HBsAg) positive mothers. METHODS: A total of 158 infants were enrolled in the study. Fifty eight infants were enrolled in the GeneVac-B group while 50 each were included for Engerix B and Shanvac B groups. A three-dose regimen of vaccination; at birth (within 24 h of birth), 1st mo and 6 mo. were adopted with 10 μg dosage administered uniformly in all the three groups. Clinical and immunological parameters were assessed for safety and immunogenicity of the vaccines, in all the enrolled infants. RESULTS: Successful follow up until seven months of age was achieved in 83/ (48/58) for GeneVac-B, 76/ (38/50) and 64/ (32/50) for Engerix B and Shanvac B groups respectively. 100/ seroconversion and seroprotection was achieved in all the three groups of infants. The geometric mean titers of anti-HBs one month after the completion of three dose of vaccination were 90.5, 80.9 and 72.5 mIU/mL in GeneVac-B, Engerix B and Shanvac B vaccine group respectively. Furthermore the level of anti-HBs increases with age ofbabies who were born to HBsAg positive mothers. The GMT values of anti-HBs were 226.7, 193.9 and 173.6 mIU/mL respectively in GeneVac-B, Engerix B and Shanvac B groups one year after the completion of the three doses of vaccine. No systemic reactions were reported in infants during the entire vaccination process of GeneVac-B and the other two vaccines. Clinical safety parameters remained within the normal limits throughout the study period.CONCLUSION: The study concludes that there is no significant difference between the three recombinant hepatitis B vaccines. Administration of these vaccines within 24 h of birth to babies, born to HBsAg positive mothers will reduce the incidence of HBV infection.