Hepatitis B ; prevention & control ; Hepatitis B Vaccines ; adverse effects ; Humans ; Immunization

Adolescent ; Female ; Hepatitis B Vaccines ; adverse effects ; Humans ; Multiple Sclerosis ; etiology ; Vaccination ; adverse effects

<b>OBJECTIVEb>To study the safety and immunogenicity of the Bilive combined hepatitis A and B vaccine produced by Sinovac Biotech Co., Ltd.

<b>METHODSb>Samples were selected from first year students of a senior high school (adults group) and first to fifth grade 1-5 students of 3 primary schools (children group). Those who were susceptible to both hepatitis A virus (HAV) and hepatitis B virus (HBV), HAV only or HBV only were assigned to group AB, A and B respectively and were vaccinated with three doses (0, 1 and 6 month schedule) of Bilive combined hepatitis A and B vaccine, inactivated hepatitis A vaccine and recombined hepatitis B vaccine respectively. The dosage for adult group was 500 U hepatitis A antigen and/or 10 micro g hepatitis B surface antigen and the dosage for children group was half the dosage of adult group. The potential adverse effects were observed within 72 hours after vaccination. Serum samples were collected for testing anti-HAV and anti-HBs at month 2 and 7 after the initial dose.

<b>RESULTSb>The rates of local adverse effects were 0.58% and 2.56% in children AB group and adults AB group and the general adverse effects rates were 9.88% and 5.45% respectively. Both local and general adverse effect rates were not significantly different to the control group. The sero-conversion rate of anti-HAV in children and adults AB group reached 100%, one month after 3 doses. The geometric mean titer (GMTs) reached 33,910 mIU/ml and 23,435 mIU/ml respectively, significant higher than that in control group (group A). The sero-conversion rates of anti-HBs were 97.30% and 96.63%, and GMTs were 103 mIU/ml and 102 mIU/ml in children and adults AB group respectively. No significant difference on sero-conversion and GMT was observed when compared with control group.

<b>CONCLUSIONb>The Bilive combined hepatitis A and B vaccine had good safety profile, and the immunogenicity both on anti-HAV and anti-HBs was similar to that of separated components.

Adolescent ; Adult ; Child ; Female ; Hepatitis A ; prevention & control ; Hepatitis A Antibodies ; blood ; Hepatitis A Vaccines ; administration & dosage ; adverse effects ; immunology ; Hepatitis Antibodies ; blood ; Hepatitis B ; prevention & control ; Hepatitis B Antibodies ; blood ; Hepatitis B Vaccines ; administration & dosage ; adverse effects ; immunology ; Humans ; Male ; Safety ; Vaccines, Combined ; administration & dosage ; adverse effects ; immunology ; Vaccines, Synthetic ; administration & dosage ; adverse effects ; immunology

<b>OBJECTIVEb>To assess the feasibility of the 10 microg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5 - 18.

<b>METHODSb>People with both HBsAg and anti-HBs negative were selected to take two-stage clinical experiment and the safety and immunogenicity were observed. Safety observation was conducted in 925 subjects, while 568 for immunogenicity. The observation group (aged 5 - 18) included 493 subjects, and (age > 18) 75 enrolled in control group. For the observation group, there were three sub-groups including a child group (141, aged 5 - 6), early youth group (177, aged 12 - 13), and youth group (175, aged 16 - 18). Both groups were administered with 10 microg recombination yeast hepatitis B vaccines with 3 doses at 0 month, 1st month, 6th month. To assess the immunogenicity, the vaccination reactions were observed during the following 4 weeks in order to assess the vaccine safety. The blood samples were taken during 4 - 6 weeks after fully vaccinated, and then anti-HBs were tested with RIA and analyzed by comparing the positive rate of anti-HBs, the geometric mean titer (GMT) and the protective rate between the two groups.

<b>RESULTSb>Both observation and control group didn't show any general reactions, adverse events following immunization (AEFI) or coincidental cases when observed at 0.5 h, 6 h, 24 h, 48 h, 72 h, 1 week, 2 weeks, 3 weeks, 4 weeks after being vaccinated. The result of serum test showed, the positive rates of child group, early youth group, youth group and control group were respectively 100.00% (141/141), 97.18% (172/177), 98.29% (172/175) and 89.33% (67/75); the GMTs of anti-HBs were respectively 440.28, 875.38, 467.80, 131.06 U/L; the protective rates were respectively 100.00% (141/141), 97.18% (172/177), 97.14% (170/175) and 86.67% (65/75). The positive rate, GMT and protective rate of the experimental group were all higher than that of control group (chi(2)(positive rate) = 12.77, 5.12, 7.99; t(GMT) = 3.89, 4.13, 5.91; chi(2)(protective rate) = 16.81, 8.60, 8.44; P < 0.05).

<b>CONCLUSIONb>This vaccine could be expanded to 5 - 18 year-old population with safety and effectiveness, the positive rate and protective rate of anti-HBs were both higher than that of control group.

Adolescent ; Child ; Child, Preschool ; Female ; Hepatitis B Antibodies ; blood ; immunology ; Hepatitis B Surface Antigens ; blood ; immunology ; Hepatitis B Vaccines ; administration & dosage ; adverse effects ; immunology ; Humans ; Male ; Vaccines, Synthetic ; administration & dosage ; adverse effects ; immunology

<b>OBJECTIVEb>To evaluate the safety and immunogenicity of the Bilive(TM) combined hepatitis A and hepatitis B vaccine in healthy children.

<b>METHODSb>A total of 116 healthy children aged 1 - 10 years, who, without history of hepatitis A vaccine vaccination and anti-HAV negative, had completed the full immunization of hepatitis B vaccine were recruited in city of Changzhou in Jiangsu province. The Bilive(TM) combined hepatitis A and hepatitis B vaccine was administered according to a two-dose schedule (0, 6 months). The dosage was 250 U for hepatitis A antigen and 5 microg for hepatitis B surface antigen. The potential adverse effects were observed within 72 hours after vaccination. The serum samples were collected for the testing of anti-HAV and anti-HBs at month 1, 6 and 7 after initial dose.

<b>RESULTSb>The local and systemic adverse reactions after immunization were slight and temporary. The rates of local and systemic adverse reactions were 12.1% (14/116) and 6.0% (7/116). The sero-conversion rates of HAV were from 92.9% (92/99) to 100.0% (101/101) and the geometric mean titers (GMT) ranged from 47.0 mIU/ml to 2762.3 mIU/ml 1, 6, 7 months after initial dose. The sero-protection rate of HBV was 86.1% (87/101) before vaccination and came up to 100.0% (101/101) one month after initial dose, and the GMTs of HBV were from 894.3 mIU/ml to 3314.3 mIU/ml 1, 6, 7 months after initial dose.

<b>CONCLUSIONb>The Bilive(TM) combined hepatitis A and hepatitis B vaccine has good safety and immunogenicity in healthy children who had preexisting immunity to hepatitis B virus.

Child ; Child, Preschool ; Dose-Response Relationship, Immunologic ; Female ; Hepatitis A Vaccines ; adverse effects ; immunology ; Hepatitis B Vaccines ; adverse effects ; immunology ; Humans ; Immunization Schedule ; Infant ; Male ; Vaccines, Combined ; adverse effects ; immunology

<b>OBJECTIVEb>To study the effect and mechanism of the peripheral blood mononuclear cell (PBMC) invasion by HBV on artificial immunization in newborns.

<b>METHODSb>Fifty-two newborns of HBsAg positive mothers were immunized with HBIG (hepatitis B immunoglobulin) and HBVac (hepatitis B vaccine) and were followed up for 7 months. The newborns' HBV-DNA in serum and in the PBMCs was detected with nested-PCR; anti-HBs was tested with solid phase radioimmunoassay (SP-RIA). PBMCs isolated from newborn peripheral blood were incubated in the presence of PHA or purified HBsAg. Interleukin-2 (IL-2) level in culture supernatants of activated cells was detected by ELISA.

<b>RESULTSb>The failure rate of immunization was higher in infants with positive HBV-DNA in PBMCs than those with negative HBV-DNA (P < 0.05); IL-2 level in PBMC culture supernatants was lower in former than in the latter and in normal controls (P < 0.05). The level of IL-2 in the immunization failure newborns was lower than that in the successfully immunized newborns and in normal controls (P < 0.05).

<b>CONCLUSIONSb>Intrauterine invasion of PBMCs by HBV is one of the important reasons for immunization failure in newborns. IL-2 production is closely related to the invasion of PBMCs by HBV, which may contribute to the failure of artificial immunization in newborns.

DNA, Viral ; blood ; Hepatitis B Surface Antigens ; immunology ; Hepatitis B Vaccines ; adverse effects ; Hepatitis B virus ; isolation & purification ; physiology ; Humans ; Immunization ; adverse effects ; Immunoglobulins ; immunology ; Infant, Newborn ; Interleukin-2 ; biosynthesis ; blood ; Leukocytes, Mononuclear ; virology

We report a case of myelitis after plasma-derived hepatitis B vaccination. The patient was a 31-year-old man who presented with progressive sensory symptoms in extremities that developed 2 weeks after a third vaccination. MRI of the cervicothoracic region revealed swelling and T2 high signal at the level of C4 to C5 cord, and isolated enhancement in the posterior columns between C4 and C5 cord. The significance of MRI findings and HLA haplotype of the patient will be briefly discussed.
Acute Disease ; Adult ; Case Report ; Hepatitis B Vaccines/adverse effects* ; Human ; Magnetic Resonance Imaging ; Male ; Myelitis/pathology ; Myelitis/chemically induced*

<b>OBJECTIVEb>We report the first case of acute encephalopathy induced by vaccination in an infant with methylmalonic aciduria cblA in China.

<b>METHODb>The clinical presentation, blood acylcarnitines analysis, urine organic acids analysis and gene studies of the patient were summarized.

<b>RESULTb>The proband, a boy, was admitted at the age of 15 months because of recurrent vomiting, acidosis and development delay for 8 months. The previously healthy boy presented vomiting and coma just one hour after hepatitis B vaccination at the age of seven months. Moderate dehydration, electrolyte disturbance and metabolic acidosis had been found. Although his acute metabolic crisis had been corrected soon after intravenous transfusion, psychomotor retardation and recurrent vomiting had been observed. When he was 15 months old, vomiting and lethargy occurred again 3 hours after DTaP vaccination. He was weakened as the illness became worse and got coma with dyspnea 7 days later. He was hospitalized with the suspected diagnosis of viral encephalitis. Blood acylcarnitines analysis, urine organic acids analysis and gene study had been performed for the etiologic investigation.His blood propionylcarnitine (16.3 µmol/L vs. normal range 1.0-5.0 µmol/L) and propionylcarnitine/free carnitine ratio (0.27 vs. normal range 0.03 to 0.25) increased. Markedly elevated urinary methylmalonic acid (388.21 mmol/mol creatinine vs. normal range 0.2 to 3.6 mmol/mol creatinine) and normal plasma total homocysteine supported the diagnosis of isolated methylmalonic aciduria. Two mutations, c.650 T>A (p.L217X) and c.742 C>T (p.Q248X), were identified in his MMAA gene, confirmed the diagnosis of cblA. Each parent carried one of the two mutations. Progressive clinical and biochemical improvement has been observed after hydroxylcobalamin injection, protein-restricted diet with the supplements of special formula and L-carnitine. He is currently 2 years and 7 months old with normal development and general condition.

<b>CONCLUSIONb>A boy with cblA was firstly detected after the acute encephalopathy induced by vaccination in China. It is important to pay more attention to the patients with metabolic crisis or organ damage after vaccination. Metabolic studies are keys to the diagnosis of potential diseases and improve the outcome.

Amino Acid Metabolism, Inborn Errors ; complications ; Brain Diseases ; chemically induced ; Carnitine ; analogs & derivatives ; Diet, Protein-Restricted ; Hepatitis B Vaccines ; adverse effects ; Humans ; Infant ; Male ; Methylmalonic Acid ; urine ; Mutation ; Vaccination ; adverse effects ; Vitamin B Complex ; Vomiting

The S protein of hepatitis B virus is the principal component of virus envelope and the primary target of anti-HBs response. Mutants or variants that escape neutralization by anti-HBs have been selected during immunoprophylaxis of HBV after birth and liver transplantation. We investigated a case of a Korean child who was vaccinated at birth against hepatitis B and also given hepatitis B immunoglobulin, but nevertheless later became infected with the virus. Hepatitis B virus-specific deoxyribonucleic acid covering the region of genome encoding the predominant "a" determinant of hepatitis surface antigen was amplified using polymerase chain reaction, and the nucleotide sequence was determined. We present for the first time in Korea the independent emergence of an escape mutant with substitution of arginine for glycine at amino acid 145 and proline for glutamate at amino acid 120 in "a" determinant after immunization.
Cloning, Molecular ; DNA, Viral/analysis ; Epitopes, B-Lymphocyte/genetics ; Hepatitis B Surface Antigens/*genetics/immunology ; Hepatitis B Vaccines/*adverse effects/genetics/immunology ; Hepatitis B Virus/*genetics/immunology ; Hepatitis B e Antigens/blood ; Human ; Infant ; Korea ; Male ; Mutagenesis, Site-Directed ; *Mutation ; Polymerase Chain Reaction/methods ; Sequence Analysis, DNA

In order to evaluate the familial clustering of hepatitis B virus(HBV) and hepatitis C virus(HCV) infections and to elucidate the possible routes of HCV transmission among Korean adults with chronic liver disease, 137 household contacts of 51 chronic carriers of HBsAg and 111 household contacts of 38 controls, and 181 household contacts of 96 anti-HCV positives and 102 household contacts of 76 anti-HCV negatives were tested from July 1990 to March 1994. Of 71 non-vaccinated household contacts of HBsAg carriers, 10 gave positive result for HBsAg(14.1%), but none of the household contacts of the controls were positive for HBsAg(p< 0.05). Familial clustering of HBV infection was found, when the offspring of carriers and controls were compared. A significantly higher percentage of the offspring of carriers were positive for HBV infection(54.6% vs 15.4%, p< 0.05) with OR of 6.6(95% Cl; 1.3-34.5). No evidence of familial clustering of HCV infection was found with 2.2%(4/181) anti-HCV positivity among the household contacts of index cases, similar to 1.0%(1/102) among those of controls. History of acute hepatitis(OR 3.2), transfusion(OR 3.2), and acupuncture(OR 2.5) were associated with an increased risk of HCV infection. In conclusion, HBV has strong familial clustering whereas HCV does not in Korea.
Acupuncture Therapy/adverse effects ; Adolescent ; Adult ; Aged ; Biological Markers ; Blood Transfusion/adverse effects ; Carrier State ; Child ; Child, Preschool ; Cluster Analysis ; Comorbidity ; Comparative Study ; Contact Tracing ; *Family Health ; Female ; Hepatitis B/*epidemiology/prevention & control/transmission/virology ; Hepatitis B Antibodies/blood ; Hepatitis B Core Antigens/blood ; Hepatitis B Surface Antigens/blood ; Hepatitis C/*epidemiology/prevention & control/transmission/virology ; Human ; Infant ; Korea/epidemiology ; Male ; Middle Age ; Postoperative Complications/epidemiology ; Prevalence ; Risk Factors ; Seroepidemiologic Studies ; Sexually Transmitted Diseases/epidemiology ; Support, Non-U.S. Gov't ; Viral Hepatitis Vaccines