Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children.

OBJECTIVES: To compare the immunogenicity, safety, and interchangeability of two pediatric hepatitis A vaccines, Avaxim 80U-Pediatric and Havrix 720, in Chilean children. METHODS: In this randomized trial, 332 hepatitis A virus (HAV) seronegative children from 1 to 15 years of age received two doses of Avaxim, two doses of Havrix, or Havrix followed by Avaxim, 6 months apart. Anti-HAV antibody titers were measured before and 14 days after the first dose of vaccine, and before and 28 days after the second dose of vaccine. Immediate reactions were monitored; reactogenicity was evaluated from parental reports. RESULTS: Seroconversion rates after the first vaccination were 99.4% and 100% for Avaxim and Havrix, respectively. Anti-HAV geometric mean concentrations (GMCs) were 138 mIU/ml for Havrix (95% confidence interval (CI): 120; 159) and 311 mIU/ml for Avaxim (95% CI: 274; 353). GMCs increased to 4008 mIU/ml after two doses of Havrix, 8537 mIU/ml following two doses of Avaxim, and 7144 mIU/ml in children who received Havrix with Avaxim as the second dose. Following the first injection, 36% of subjects given Avaxim and 44% given Havrix reported local reactions; 38% of subjects in the Avaxim group and 40% in the Havrix group reported systemic reactions related to vaccination. Solicited reactions were less frequent after the second dose of Avaxim or Havrix, occurring in 27% to 37% of subjects. CONCLUSIONS: No significant difference in seroconversion rates was seen 14 days after a single dose of vaccine. A two-dose schedule with either vaccine or with Havrix/Avaxim provided a strong booster response. Both vaccines were well tolerated and can be recommended for routine vaccination of Chilean children. Avaxim 80 may be used to complete a vaccine schedule begun with Havrix 720.     

Antibody responses to hepatitis A virus vaccine in HIV-infected children with evidence of immunologic reconstitution while receiving highly active antiretroviral therapy

BACKGROUND: Human immunodeficiency virus (HIV)-infected patients have weak responses to vaccines and may require revised immunization regimens. We investigated the safety and immunogenicity of 2 doses of hepatitis A virus (HAV) vaccine followed by a booster dose in HIV-infected children receiving stable highly active antiretroviral therapy. METHODS: A total of 235 children with CD4+ T cell percentages > or = 20% received 2 vaccine doses 24 weeks apart, and 117 received a third vaccine dose after 104 weeks. Anti-HAV antibody titers were measured at baseline and at 32, 104, and 112 weeks after the first vaccination. Subjects with antibody titers > or = 20 mIU/mL were defined as being seropositive. High and low antibody responses were defined as titers > or = 250 and <250 mIU/mL, respectively. RESULTS: Of 151 subjects who were HAV seronegative at baseline, 97% seroconverted after 2 vaccine doses, and 47% had low antibody responses. At 104 weeks, 90% of subjects had antibody titers > or = 20 mIU/mL, and those with low antibody responses were more likely to lose protective antibody titers. A third vaccine dose generated significantly higher antibody titers than those observed after the second vaccine dose. Undetectable HIV RNA at baseline was associated with higher anti-HAV antibody titers after the second vaccine dose. Antibody titers after the second and third vaccine doses were weakly correlated with CD4+ T cell percentages at the time when each vaccine dose was administered. In the 45 subjects who were HAV seropositive at baseline, responses to 2 and 3 vaccine doses were higher than those in subjects who were HAV seronegative at baseline, but the responses showed similar correlations. There were no serious adverse events associated with the vaccine. CONCLUSIONS: HIV-infected children with CD4+ T cell percentages > or = 20% responded better to the HAV vaccine if they had undetectable HIV RNA. The standard 2-dose immunization regimen generated low antibody titers with limited persistence. A third vaccine dose was safe and increased the antibody titers, suggesting that an increase in immunizations may be warranted in this population.     

Persistence of hepatitis A vaccine induced seropositivity in infants and young children by maternal antibody status: 10-year follow-up

Persistence of seropositivity conferred by hepatitis A vaccine administered to children <2 years of age is unknown and passively transferred maternal antibodies to hepatitis A virus (maternal anti-HAV) may lower the infant's immune response to the vaccine. One hundred ninety-seven infants and young children were randomized into three groups to receive a two-dose hepatitis A vaccine: group 1 at 6 and 12 months, group 2 at 12 and 18 months, and group 3 at 15 and 21 months of age. Within each group, infants were randomized by maternal anti-HAV status. Anti-HAV levels were measured at 1 and 6 months and at 3, 5, 7, and 10 years after the second dose of hepatitis A vaccination. Children in all groups had evidence of seroprotection (>10 mIU/mL) at 1 month after the second dose. At 10 years, all children retained seroprotective anti-HAV levels except for only 7% and 11% of children in group 1 born to anti-HAV-negative and anti-HAV-positive mothers, respectively, and 4% of group 3 children born to anti-HAV-negative mothers. At 10 years, children born to anti-HAV-negative mothers in group 3 had the highest geometric mean concentration (GMC) (97 mIU/mL; 95% confidence interval, 71-133 mIU/mL) and children born to anti-HAV-positive mothers in group 1 had the lowest GMC (29 mIU/mL; 95% confidence interval, 20-40 mIU/mL). Anti-HAV levels through 10 years of age correlated with initial peak anti-HAV levels (tested at 1 month after the second dose). CONCLUSION: The seropositivity induced by hepatitis A vaccine given to children <2 years of age persists for at least 10 years regardless of presence of maternal anti-HAV.     

Response to hepatitis B vaccine in preterm babies.

INTRODUCTION: A well-accepted vaccination schedule for preterm babies is not available. We therefore studied the response to hepatitis B vaccine in preterm babies. METHODS: 60 babies born to HBsAg-negative mothers were studied. Group I (n=20) consisted of term babies with birth weight >2.5 Kg, group II (n=20) included preterm babies with birth weight between 1.8 and 2.49 Kg, and group III (n=20) included preterm babies with birth weight between 1.2 and 1.79 Kg. Mean gestational age in the three groups was 38.5 (1.1), 33.5 (1.4) and 32.7 (2.1) weeks, respectively. All babies received 3 doses (10 microg/0.5 mL) of a recombinant HBV vaccine within 3 days of birth, and at 6 weeks and 6 months of life. Anti-HBs levels were measured one month after the 2nd and 3rd doses each; the immune response was categorized as good responders (anti-HBs >100 mIU/mL, low responders (anti-HBs 10-100 mIU/mL) and non-responders (anti-HBs <10 mIU/mL). RESULTS: Good antibody response after the second dose was seen in 95% of babies in group I, 60% of those in group II and 10% of those in group III. This increased to 100%, 90% and 45%, respectively after the third dose. The response was influenced by gestational age (r=0.73); 94% of babies with gestational age 34-36 weeks attained good antibody response compared to only 55% of babies with gestational age of 31-33 weeks. Birth weight had no independent influence on the antibody response. CONCLUSION: The response to hepatitis B vaccine is influenced by gestational age. Hence, in preterm babies, it is advisable to check antibody titers one month after the third dose to assess the need for a booster dose.     

Immunogenicity and safety of a new inactivated hepatitis A vaccine in Thai young adults

In view of the increasing median age of hepatitis A virus (HAV) infection observed recently in Asia, and the resulting increased number of symptomatic cases occurring in adults, with the concomitant risk of outbreaks, immunization against this agent on a national scale might be considered. An open clinical trial was conducted in Thai adolescents and young adults in order to establish the immunogenicity and safety of a new inactivated hepatitis A vaccine. At 24-week intervals, two doses (primary dose and booster) of the hepatitis A vaccine (160 antigenic units per dose) were administered to 80 HAV-seronegative healthy volunteers, their ages ranging from 16 to 25 years. Local and systemic reactions were recorded within the first 7 days after each injection. Anti-hepatitis A virus antibody concentrations were measured by a modified radioimmunoassay before and one month after each injection. No serious adverse reactions were reported. Local reactions were confined to transient pain at the injection site, occurring within 24 hours after injection in 42.5% of the subjects after the first dose and 24.1% of the patients after the booster dose. Systemic reactions (particularly asthenia or myalgia) were observed in 35.0% and 8.9% of subjects after the first and the booster injection, respectively. Most of these reactions were transient. One month after the first dose, all 78 formerly seronegative subjects had attained satisfactory seroconversion levels of anti-HAV antibody concentrations (> or = 20 mIU/ml) which they maintained until the booster. The booster dose elicited a 21-fold increase of HAV antibody levels, with a geometric mean titer of 2,964 mIU/ml (95% CI, 2,467-3,560), indicative of long-term protection. This new inactivated hepatitis A vaccine appears to be safe and highly immunogenic upon administration of a primary dose followed by a booster dose after 24 weeks. In countries where socio-economic improvement has postponed hepatitis A infection from early childhood (mostly asymptomatic) towards adolescence and adulthood, with the symptoms increasing in severity, inclusion of inactivated hepatitis A vaccine in a preventive vaccination program might be of benefit.     

Field performance of VAQTA (inactivated, purified hepatitis a vaccine) in Chinese children in Jiangsu

In Jiangsu, 30% of children between the ages of 5 and 8 years test seropositive for hepatitis A. The safety, tolerability, and immunogenicity of a 2-dose regimen (0, 6 months) of VAQTA (0.5 ml of 25U) administered IM in 50 healthy children aged 5 to 8 years without prior serological screening was evaluated. Blood samples were collected prior to the first dose and after each additional dose of VAQTA to determine the initial anti-HAV serostatus and response rates to the vaccine. Twelve children (24%) were initially seropositive and 38 (76%) were initially seronegative. Four weeks after the primary dose of VAQTA, 34 of the 38 subjects (89.5%, 95% CI 75 to 97) were anti-HAV seropositive. The geometric mean titer was 33.1 mIU/ml (95% CI 22.4 to 49.0). After the booster dose at 6 months, all the subjects were seropositive (37/37), giving a seroconversion of 100% (95% CI: 90, 100). The geometric mean titer was 7585.8 mIU/ml (95% CI: 5623.4 to 10,471.3). Adverse experiences were generally mild and transient. Results of this study are consistent with results from a previous double-blind randomized trial of this vaccine and confirm that VAQTA is highly immunogenic, and generally well-tolerated.     

Excellent booster response 4-6 y after a single primary dose of an inactivated hepatitis A vaccine

We studied the immune response of an inactivated hepatitis A vaccine (Havrix 1440) given to middle-aged travellers 4-6 y after a single, primary dose. Anti-HAV antibodies in serum were checked before and 28-35 d after the booster. All 25 vaccinees showed an impressive anamnestic booster response (geometric mean titres 32 and 2993 mIU/ml before and after the booster, respectively). The study confirms experimental data indicating that I dose of inactivated hepatitis A vaccine induces a long-term proliferative T-cell response in addition to producing anti-HAV antibody. As recall memory for this vaccine is elicited several years after a single dose there is probably no need for a second vaccine dose.     

Twelve-year follow-up of a prospective randomized trial of hepatitis B recombinant DNA yeast vaccine versus plasma-derived vaccine without booster doses in children

A total of 318 children were prospectively randomized in group 1 with two 5-microg doses of recombinant vaccine given at 0 and 1 month; in group 2 with three 5-microg doses of recombinant vaccine given at 0, 1, and 6 months; or in group 3 with three doses of plasma-derived vaccine given at 0, 1, and 6 months. Eleven subjects with a hepatitis B surface antigen antibody (anti-HBs) titer of less than 10 mIU/mL at 12 months were given an extra dose of vaccine and were excluded from analysis. No booster doses were given to any other subjects. All children were followed up yearly for the level of anti-HBs titers and for the detection of hepatitis B infection. At the 12th year of follow-up, there were significantly fewer subjects with anti-HBs of 10 mIU/mL or above in group 1 (60.4%) when compared with group 2 (81.4%; P =.0287) and group 3 (79.0%; P =. 0381). The geometric mean titers (GMTs) of subjects of group 1 were significantly lower than those of group 2 and group 3 throughout the 12 years of follow-up. A total of 65 subjects had one or more episodes of anamnestic response. No subject became positive for hepatitis B surface antigen (HBsAg); 2 became positive for hepatitis B core antigen antibody (anti-HBc). In conclusion, the long-term protective immunity was better with three doses of hepatitis B vaccine (either the recombinant or plasma-derived) than with two doses. However, protection from hepatitis B infection could be equally achieved by either two doses or three doses of the vaccine. Booster doses were not necessary, probably because of effective anamnestic response.     

Hepatitis B vaccination in high-risk infants: 10-year follow-up

The long-term efficacy of hepatitis B vaccination among high-risk infants was determined in 805 vaccine responders, immunized at birth in Taiwan during 1981-1984 and followed to age 10 years, via life table survival and Cox multivariate analyses. At 10 years, cumulative persistence of antibody to hepatitis B surface antigen (anti-HBs) was 85%, and cumulative incidence of hepatitis B virus (HBV) infection was 15%. Three children became carriers. Twelve-month anti-HBs titer was the strongest predictor of efficacy. The higher the initial titer, the lower the risk of anti-HBs loss (relative risk [RR], 0.26 for titer of 100-999 mIU/mL; RR, 0.08 for titer >1000 mIU/mL; P<.001) and HBV infection (RR, 0.55 and 0.27; P<.05). Maternal hepatitis B e antigen positivity but not hepatitis B immunoglobulin dose or gender predicted greater antibody persistence to age 10 years. Because the level of antibody persistence remained high and few became carriers, booster revaccination within 10 years seems unnecessary.     

Immunogenicity of three recombinant hepatitis B vaccines administered to students in three doses containing half the antigen amount routinely used for adult vaccination

We evaluated the immunogenicity of three recombinant hepatitis B vaccines, one Brazilian (Butang, Instituto Butantan) and two Korean vaccines (Euvax-B, LG Chemical Ltd. and Hepavax-Gene, Greencross Vaccine Corp.), administered intramuscularly to students aged 17 to 19 years in three 10- micro g doses (corresponding to half the amount of antigen routinely used for adult vaccination) at intervals of one month between the first and second dose, and of four months between the second and third dose. A total of 316 students non-reactive for any serological marker of hepatitis B virus infection were vaccinated: 77 (24.4%) with the Butang vaccine, 71 (22.5%) with Euvax-B, 85 (26.9%) with Hepavax-Gene and, for comparison, 83 (26.2%) with Engerix-B (GlaxoSmithKline), whose efficacy in young adults at the dose used here has been confirmed in previous studies. Similar seroconversion rates (anti-HBs > 10 mIU/mL about one month after application of the third dose) were obtained for the Butang, Euvax-B, Hepavax-Gene and Engerix-B vaccines (96.2%, 98.6%, 96.5% and 97.6%, respectively). The frequency of good responders (anti-HBs > 100 mIU/mL) was also similar among students receiving the four vaccines (85.8%, 91.6%, 89.4% and 89.2%, respectively). The geometric mean titers (GMT) of anti-HBs about one month after the third dose obtained with these vaccines were 727.78 +/- 6.46 mIU/mL, 2009.09 +/- 7.16 mIU/mL, 1729.82 +/- 8.85 mIU/mL and 2070.14 +/- 11.69 mIU/mL, respectively. The GMT of anti-HBs induced by the Euvax-B and Engerix-B vaccines were higher than those obtained with the Butang vaccine (p < 0.05); this difference was not significant when comparing the other vaccines two-by-two. No spontaneous adverse effects attributable to the application of any dose of the four vaccines were reported.     

18-year follow-up study of a prospective randomized trial of hepatitis B vaccinations without booster doses in children.

BACKGROUND & AIMS: The long-term immunogenicity and efficacy of hepatitis B virus (HBV) vaccination remain to be defined. We aimed to examine the long-term immunogenicity and efficacy of HBV vaccination with 3 different regimens over 18 years of follow-up. METHODS: A total of 318 Chinese subjects receiving 3 different regimens of HBV vaccination (2-dose recombinant vs. 3-dose recombinant vs. 3-dose plasma-derived vaccines) without receiving a booster dose were recruited. The HBV serologic markers, including hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), were determined at yearly follow-up. After 18 years, 88 subjects were still being followed up. RESULTS: Compared with subjects receiving the 2-dose regimen, subjects receiving the 3 dose regimens had a significantly higher geometric mean titer of anti-HBs and a higher proportion had anti-HBs titers > or =10 mIU/mL during the 18 years of follow-up. There were no differences in these 2 parameters between subjects receiving the 3-dose recombinant and subjects receiving the 3-dose plasma-derived vaccines. A total of 88 anamnestic responses were documented in 70 subjects (8 with initial anti-HBs titers <100 mIU/mL at 12 months and 7 with anti-HBs titers <10 mIU/mL before the anamnestic responses). No subject became positive for HBsAg. Three subjects had benign breakthrough HBV infection without leading to chronicity indicated by isolated anti-HBc positivity. CONCLUSIONS: There was less long-term immunogenicity associated with the 2-dose regimen when compared with the 3-dose regimens of HBV vaccination. Because of the highly effective anamnestic responses, a booster dose was not necessary at least up to 18 years after the primary vaccination.     

Evaluation of immunogenicity and reactogenicity of recombinant DNA hepatitis B vaccine produced in India

AIM: (1) To gain information on immune responses to an accelerated schedule of 0,1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. (2) To assess the efficacy and safety of Enivac-HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B vaccine developed and manufactured in India. METHODS: A prospective, comparative, and single blinded trial of rapid (0, 1, and 2 mo) hepatitis B immunization schedulewas reported. A total of three hundred and seven (212 females and 95 males) healthy volunteers divided into three age groups (18-29, 30-39, and 40-49) were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo. RESULTS: Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 (96.5%) subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/ mL, while that in the age group of 30-39 years was 2 096.0 mIU/mL. In third age group of 40-49 years, anti-HBs titer was 1 592.0 mIU/mL. Hyper-responses (anti- HBs≥100 mIU/mL) were shown in 88.0% (271/307) of subjects. Eleven (3.5%) subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions (ADRs). CONCLUSION: This vaccine (Enivac-HB) is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended whenever rapid protection is the goal.     

Protection provided by hepatitis B vaccine in a Yupik Eskimo population. Seven-year results.

The long-term immunogenicity and protection provided by a plasma-derived hepatitis B vaccine (Heptavax B) was determined in a cohort of susceptible persons immunized in 1981. In this study 1581 susceptible persons were immunized with the recommended three-dose regimen of hepatitis B vaccine. After 7 years, 74% of vaccinees retained antibody to hepatitis B surface antigen (anti-HBs) levels of 10 mIU/mL or more. Anti-HBs levels at 7 years varied inversely with age and directly with the level of anti-HBs attained 1 year after the first dose. During the 7 years after the first dose of vaccine, five vaccine responders and three other persons developed antibody to hepatitis B core antigen and their level of anti-HBs increased. None developed detectable hepatitis B surface antigen or clinical hepatitis. This update of an ongoing study continues to suggest that the risk of hepatitis B virus infection to most persons with an initial anti-HBs response to hepatitis B virus vaccine of 10 mIU/mL or greater is low, regardless of the initial antibody level.     

A randomized double-blind clinical trial of a mammalian cell-derived recombinant DNA hepatitis B vaccine compared with a plasma-derived vaccine

Eight hundred volunteers from heath care and emergency fields participated in a randomized double-blind clinical trial of a new experimental mammalian cell-derived recombinant DNA hepatitis B vaccine (Betagen) compared with a licensed plasma-derived vaccine (Heptavax-B). Vaccine injections (20 micrograms) were administered intramuscularly at 0, 1, and 6 months, and sera were tested at 0, 1, 2, 3, 6, 7, and 12 months for hepatitis B surface antigen, antibody to hepatitis B surface antigen, and antibody to hepatitis B core antigen. Data from 745 vaccinees (93.1%), analyzed at the 7th month of follow-up, showed no significant difference in the seroconversion rates for Betagen (94.4%) vs Heptavax-B (97.3%), but the geometric mean titer of antibody was significantly higher for Heptavax-B (11 833 mIU/L) than for Betagen (4628 mIU/mL). The antibody response of Betagen was significantly and independently related to age and sex, while that of Heptavax-B was related to age only. Reported side effects from both vaccines were minor and mild, with approximately one fourth of all vaccinees reporting at least one side effect. Vaccinees, who had a protective level of antibody at the 7th month, were tested for antibodies at the 12th month. Of those in the Betagen-vaccinated group and those in the Heptavax-B-vaccinated group, 99.0% and 100%, respectively, were still protected. There was a proportionately larger decline in the geometric mean titers of antibody to hepatitis B surface antigen for Heptavax-B than for Betagen.     

Persistence of antibody to Hepatitis A virus 20 years after receipt of Hepatitis A vaccine in Alaska

Hepatitis A vaccine is recommended for children ≥1 year old to prevent hepatitis A virus (HAV) infection. However, the duration of vaccine‐induced immunity is unknown. We evaluated a cohort of Alaska Native persons 20 years after HAV vaccination. Children aged 3‐6 years had been previously randomized to receive three doses of HAV vaccine (360 ELISA units/dose) at: (i) 0,1,2 months; (ii) 0,1,6 months; and (iii) 0,1,12 months. We measured anti‐HAV antibody concentrations every 2‐3 years; described geometric mean concentrations (GMC) and the proportion with protective antibody (≥20 mIU mL^‐1) over time; and modelled the change in GMC using fractional polynomial regression. Of the 144 participants, after 20 years 52 (36.1%) were available for the follow‐up (17, 18, 17 children in Groups A, B and C, respectively). Overall, 46 (88.5%) of 52 available participants had anti‐HAV antibody concentrations ≥20 mIU mL^‐1, and overall GMC was 107 mIU mL^‐1. Although GMC levels were lower in Group A (60; CI 34‐104) than in Group B (110; CI 68‐177) or Group C (184; CI 98‐345) (B vs C: P=.168; A vs B/C: P=.011), there was no difference between groups after adjusting for peak antibody levels post‐vaccination (P=.579). Models predicted geometric mean concentrations of 124 mIU mL^‐1 after 25 years, and 106 mIU mL^‐1 after 30 years. HAV vaccine provides protective antibody levels 20 years after childhood vaccination. Lower antibody levels in Group A may be explained by a lower initial peak response. Our results suggest a booster vaccine dose is unnecessary for at least 25‐30 years.     

Comparison of the immunogenicity of hepatitis B vaccine administered intradermally and intramuscularly

Although hepatitis B vaccine reliably induces immunity to hepatitis B virus, the expense of intramuscular (im) vaccination with this product has limited its use. To determine if a smaller, less expensive, intradermal (id) dose of hepatitis B vaccine would be an effective alternative, we compared the response of antibody to hepatitis B surface antigen (anti-HBs) following im vaccination to that following id vaccination. Volunteers who were seronegative for antibody to hepatitis B core antigen were enrolled in the study and received either im or id vaccine. A total of 108 subjects received three 1-mL im injections of hepatitis B vaccine, and another 110 subjects received four 0.1-mL id injections of the vaccine. Similar rates of seroconversion occurred; greater than or equal to 10 mIU of anti-HBs/mL was noted following either three im or three id vaccinations. Furthermore, 2 years after initiation of vaccination, the serum concentration of anti-HBs for id vaccine recipients was similar to that for im vaccine recipients.     

Efficacy of hepatitis B vaccination in primary school children from a village endemic for Schistosoma mansoni.

To determine whether chronic Schistosoma mansoni infection interferes with hepatitis B virus (HBV) immunization, 308 schoolchildren aged 6-12 years with no evidence of prior HBV infection (156 with active schistosomiasis) were vaccinated with three 5-micrograms injections of recombinant DNA-derived HBV vaccine. The vaccine was given in the deltoid muscle at time 0 and 1 and 7 months later. All vaccinees were examined 1 and 3 years after vaccination for quantitative antibody to hepatitis B surface antigen (anti-HBs). Seroconversion was detected in 284 vaccinated children (92%), of whom 271 had a good (51-300 mIU/mL) or excellent (greater than 300 mIU/mL) anti-HBs response. Sixteen other children (5%) had evidence of natural HBV infection (antibody to hepatitis B core antigen). Of those with good or excellent response, 99% retained high antibody titers for 3 years. Response was not influenced by S. mansoni infection. Hepatomegaly and splenomegaly were associated with reduced vaccine response.     

Compliance to hepatitis B vaccination and subsequent development of seroprotection among health care workers of a tertiary care center of Saudi Arabia

BACKGROUND: There is lack of reliable data on compliance to hepatitis B virus (HBV) vaccine and development of seroprotective levels of antibodies among health care workers (HCWs) from the countries with high HBV endemicity such as Saudi Arabia. This study aimed to assess the compliance with HBV vaccine and subsequent levels of seroprotection among HCWs of a large tertiary care center of the Eastern Province of Saudi Arabia. METHODS: All the HCWs (n = 1302) involved in direct patient care, including 374 (28.7%) physicians, 619 (47.6%) nurses, and 309 (23.7%) technicians, were enrolled for the study. Those having antibody to hepatitis B surface antigens (anti-HBs) levels less than 10 mIU/mL were advised to take 3 doses of yeast-derived recombinant HBV vaccine at 0, 1, and 6 months of 1 mL (20 microg/mL) in the deltoid muscle. Blood samples were checked for anti-HBs antibody levels by enzyme immunoassay during the initial screening of HCWs and 3 months after the third dose of HBV vaccine. The group of physicians included 34.5% (129/374) of consultants, 16.8% (63/374) of specialists, and 48.6% (182/374) of residents. RESULTS: An overall HBV vaccine compliance rate of 71.6% (932/1302) was observed among HCWs including that of 79.5% (492/619) among nurses, 78.3% (242/309) among technicians, and 52.9% (198/374) among physicians. Thus, physicians recorded the lowest compliance (OR, 3.211; 95% CI, 2.259-4.567; P < .0001) to HBV vaccine. Among physicians, the lowest compliance of 42.3% (77/182) was observed in residents (OR, 3.690; 95% CI, 1.067-3.703; P < .0001). The overall seroprotection after vaccination was achieved in 92.2% of the compliant HCWs, and 7.8% of them failed to mount adequate response to HBV vaccine. Nonresponders included mainly the physicians (OR, 2.229; P = .05)-consultants in particular (OR, 3.476; P < .0001). The mean age of nonresponders was higher than those who mounted an adequate anti-HBs response (46.7 +/- 6.3 vs. 32.2 +/- 3.3 years OR, 1.845; 95% CI, 0.999-3.414; P < .05). CONCLUSIONS: Poor compliance to HBV vaccine among physicians--residents in particular-is an issue of immense concern, which demands close examination and identification of the specific action that needs to be taken to enhance the uptake of the vaccine by this target population.     

Induction of cellular and humoral immunity after aerosol or subcutaneous administration of Edmonston-Zagreb measles vaccine as a primary dose to 12-month-old children

Infants were immunized by aerosol (10(3.6) plaque-forming units [pfu]/dose) or subcutaneous (sc) (10(4.27) pfu/dose) administration of Edmonston-Zagreb measles vaccine. Measles-specific T cell proliferative responses with a stimulation index of > or =3 developed in 72% of children given aerosol-administered vaccine, compared with 87% given s.c.-administered vaccine (P =.06). Seroconversion rates were 90% after aerosol-administered vaccine and 100% after s.c.-administered vaccine (P=.01), and measles geometric mean titers were 237 milli-international units (mIU) (95% confidence interval [CI], 146-385 mIU) and 487 mIU (95% CI, 390-609 mIU) in each group, respectively (P=.01). Measles-specific T and B cell responses were weaker after aerosol than after sc vaccination, indicating a need to use a higher aerosol dose to achieve optimal immunogenicity.     

Long-term persistence of immunity to hepatitis B after vaccination during infancy in a country where endemicity is low

BACKGROUND: The long-term response to hepatitis B vaccination during infancy has not been fully evaluated in countries where endemicity is low. METHODS: The present study was a serological investigation of immunity to hepatitis B during adolescence. In a cohort of children who were born to hepatitis B virus carrier mothers and who were vaccinated during infancy, evidence of past or current infection and the response to a single booster dose of vaccine were analyzed. Sixty-four children whose antibody levels were measured after immunization (group 1) and 52 younger siblings who did not undergo postvaccination antibody tests (group 2) were studied. RESULTS: One child in each group showed evidence of natural infection. In group 1, 32 children (50%) had undetectable antibody to hepatitis B surface antigen (anti-HBs), and only 8 (13%) had levels >100 mIU/mL. After a booster dose of vaccine, only 7 (11%) still had undetectable anti-HBs, 3 (5%) showed a primary response, and 50 (78%) had levels >100 mIU/mL. Five of the 7 vaccine nonresponders and all of the primary responders had also received hepatitis B-specific immunoglobulin (HBIG) at birth. The children in group 2 showed a similar response to the vaccine, but with slightly higher levels of anti-HBs. CONCLUSIONS: Most children vaccinated at birth retain immunological memory to hepatitis B vaccine for 15 years, but those who did not were more likely to have received HBIG at birth, suggesting that passive antibody may interfere with the induction of immunological memory.