Adjuvants, Immunologic ; administration & dosage ; Animals ; Bacterial Vaccines ; immunology ; Disease Models, Animal ; Genetic Engineering ; Helicobacter pylori ; immunology ; Humans ; Immunity, Mucosal ; Vaccines, Synthetic ; immunology

OBJECTIVETo assess the feasibility of the 10 microg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5 - 18.

METHODSPeople 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.

RESULTSBoth 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).

CONCLUSIONThis 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

To investigate the feasibility of using recombinant adeno-associated virus type 1 vector as prophylactic vaccine against HPV16 infection, rAAV1-mod. HPV16L1, the recombinant AAV1 vector containing codon-modified HPV16 L1 gene, was constructed. C57BL/6 mice were immunized with purified rAAV1 vector through intramuscular and intranasal inoculation routes, and the titer of neutralizing antibody was determined by neutralization assay based on HPV16 pseudovirus. The result shows that the single dose of rAAV1-mod. HPV16L1 can induce specific neutralizing antibody in serum through both inoculation routes. Compared with intranasal group, intramuscular group can induce higher titer of neutralizing antibody. Eliciting strong and prolonged neutralizing antibody in serum, the rAAV1-mod. HPV16L1 is one of promising HPV16 prophylactic vaccine candidates.
Animals ; Antibodies, Viral ; blood ; Capsid Proteins ; genetics ; immunology ; Dependovirus ; genetics ; Female ; Mice ; Mice, Inbred C57BL ; Oncogene Proteins, Viral ; genetics ; immunology ; Papillomavirus Vaccines ; administration & dosage ; immunology ; Vaccination ; Vaccines, Synthetic ; administration & dosage ; immunology

OBJECTIVETo determine the efficacy of recombinant hepatitis B (rHB) vaccine and low-dose hepatitis B immune globulin (HBIG) in the prevention of mother-infant transmission of hepatitis B virus (HBV) infection.

METHODSrHB vaccine was administered to two groups of healthy neonates born to mothers with both hepatitis B surface antigen and e antigen positive in Guangxi, Hunan and Hebei province. Two hundred eighty-nine subjects were included in active immunization group, receiving triple doses of rHB vaccine given i.m. at 0, 1 and 6 month intervals; while 186 subjects receiving 50 IU HBIG at birth with triple doses of rHB vaccine in the low-dose HBIG group.

RESULTSEfficacy of active immunization alone was 87.8% (95% CI: 83.6 - 91.9). Efficacy of rHB vaccine and HBIG was 91.2% (95% CI: 86.7 - 95.6). No significant differences in efficacy by type of rHB vaccine (P = 0.707 2), immunoprophylaxis programs (P = 0.295 5) and regions of living (P = 0.998 7) were noticed. Seroprotection rates (anti-HBs >or= 10 mIU/ml) were detected in 91.1% and 93.5% in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with geometric mean titer (GMT) of 153 mIU/ml and 164 mIU/ml at 1 year of age, respectively. Anti-rHBs decreased significantly with years after vaccination (chi(2) = 60.47, P = 0.000 1). Seroprotection rates of anti-rHBs antibodies decreased to 65.0% and 66.6% at 4 years of age in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with GMT of 55 mIU/ml and 56 mIU/ml, respectively.

CONCLUSIONThese results suggested that the effectiveness of rHB vaccine plus low-dose HBIG was much better than only active plasma-derived vaccine; however, methods used for anti-rHBs assay need to be evaluated and verified.

China ; epidemiology ; Female ; Hepatitis B ; epidemiology ; prevention & control ; transmission ; Hepatitis B Antibodies ; administration & dosage ; Hepatitis B Vaccines ; immunology ; Humans ; Immunization Schedule ; Immunoglobulin G ; administration & dosage ; Infant, Newborn ; Infectious Disease Transmission, Vertical ; prevention & control ; Male ; Vaccination ; Vaccines, Synthetic ; immunology

OBJECTIVETo study the safety and immunogenicity of the Bilive combined hepatitis A and B vaccine produced by Sinovac Biotech Co., Ltd.

METHODSSamples 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.

RESULTSThe 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.

CONCLUSIONThe 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

OBJECTIVETo evaluate the kinesis of cellular immunity in adults who were vaccinated with yeast recombinant hepatitis B(rHB) vaccine and the correlation between cellular and humoral immune responses induced by the vaccine.

METHODSEight adults were vaccinated with rHB vaccine according to 0, 1,2 month schedule. The peripheral blood mononuclear cells(PBMCs) were collected at the 3, 8, 21, 34 and 65 days after the first dose. The high purity of CD4+ and CD8+ T cells obtained by sorting from PBMCs were restimulated with recombinant hepatitis B surface antigens (rHBsAg) or peptides. The spot forming cell (SFC) of IFN-gamma, IL-2 and IL-4 of CD4+ and CD8+ T cells were detected by enzyme-linked immunospot (ELISPOT).

RESULTSThe characteristics of IFN-gamma, IL-2 and IL-4 of CD4+ and CD8+ T cells appeared different after immunization with rHB vaccine. IFN-gamma of CD8+ and CD4+ T cells could be detected early with stable SFC, while the IL-2 and IL-4 of CD4+ T cells appeared late but increased after the second and third dose of vaccination. The positive rate of IL-4 of CD4+ T cells were significantly correlated with the positive rate of anti-HBs, while the SFCs of IL-4 and IL-2 of CD4+ T cells were also significantly related to the titers of anti-FIBs.

CONCLUSIONIFN-gamma could be detected early after rHB vaccination in adults, and the positive rates of IL-4 and IL-2 were correlated with that of anti-HBs.

Adult ; CD4-Positive T-Lymphocytes ; CD8-Positive T-Lymphocytes ; Hepatitis B Vaccines ; administration & dosage ; immunology ; Humans ; Immunization Schedule ; Interferon-gamma ; blood ; Interleukin-2 ; blood ; Interleukin-4 ; blood ; Vaccines, Synthetic ; immunology

OBJECTIVE: To determine the immune-protective effect of Japan Schistosoma (Chinese mainland strain) 23 kD membrane protein-heat shock protein (SjC23-Hsp70) DNA vaccine plus adjuvantinduced interleukin-12 (IL-12) plasmid DNA on Schistosoma japonicum infection in water buffalos. METHODS: Forty-five health water buffalos (8-10 months old) in non-endemic area of schistosomiasis were randomly assigned into group A (SjC23-Hsp70+IL-12, 300 μg), group B (SjC23+IL-12, 300 μg) and group C (pVAX+IL-12, 300 μg), 15 in each group. Each buffalo was immuned by shoulder intramuscular injection for 3 times, at an interval of 28 days. Twenty-eight days after the last immunization, each buffalo was infected with 1000 Japan cercariae of Schistosoma. Fecal examinations were conducted 2 days and 1 day before the perfusion, and on the day of perfusion. The number of hatching miracidia and eggs per gram feces was recorded. Fifty-six days after the infection, the buffalos were sacrificed and perfused via the descending aorta. The recovered adult worms and eggs in the liver tissue were counted. RESULTS: We compared group A and B with group C: the estrogen reduction rate was 45.7% and 26.61%; bug reduction rate was 44.51% and 25.84%; the fecal egg reduction rate was 41.1% and 31.63%; the miracidium reduction rate was 48.11% and 38.07%; and the liver egg reduction rate was 43.39% and 31.95%. The above rates in group A were higher than those in group B (P<0.05). CONCLUSION SjC23-Hsp70 DNA vaccine combined with IL-12 may have a significant immunoprotective effect on buffalos.
Animals ; Antigens, Helminth ; immunology ; Buffaloes ; Cattle ; HSP70 Heat-Shock Proteins ; genetics ; immunology ; Helminth Proteins ; immunology ; Immunization ; methods ; Interleukin-12 ; genetics ; immunology ; Membrane Proteins ; immunology ; Schistosomiasis japonica ; immunology ; prevention & control ; veterinary ; Vaccines, DNA ; administration & dosage ; immunology ; Vaccines, Synthetic ; immunology

A novel recombinant Bacille Calmette-Guerin (rBCG) vaccine co-expressed Eimeria tenella rhomboid and cytokine chicken IL-2 (chIL-2) was constructed, and its efficacy against E. tenella challenge was observed. The rhomboid gene of E. tenella and chIL-2 gene were subcloned into integrative expression vector pMV361, producing vaccines rBCG pMV361-rho and pMV361-rho-IL2. Animal experiment via intranasal and subcutaneous route in chickens was carried out to evaluate the immune efficacy of the vaccines. The results indicated that these rBCG vaccines could obviously alleviate cacal lesions and oocyst output. Intranasal immunization with pMV361-rho and pMV361-rho-IL2 elicited better protective immunity against E. tenella than subcutaneous immunization. Splenocytes from chickens immunized with either rBCG pMV361-rho and pMV361-rho-IL2 had increased CD4+ and CD8+ cell production. Our data indicate recombinant BCG is able to impart partial protection against E. tenella challenge and co-expression of cytokine with antigen was an effective strategy to improve vaccine immunity.
Adjuvants, Immunologic/genetics/*metabolism ; Administration, Intranasal ; Animals ; Antigens, Protozoan/genetics/*immunology ; BCG Vaccine/administration & dosage/*genetics ; CD4-Positive T-Lymphocytes/immunology ; CD8-Positive T-Lymphocytes/immunology ; Chickens ; Coccidiosis/*prevention & control ; Disease Models, Animal ; Drug Carriers/administration & dosage ; Eimeria tenella/genetics/*immunology ; Genetic Vectors ; Injections, Subcutaneous ; Interleukin-2/genetics/*metabolism ; Protozoan Vaccines/administration & dosage/genetics/*immunology ; Spleen/immunology ; Vaccines, Synthetic/administration & dosage/genetics/immunology

OBJECTIVETo study the safety, immunogenicity on the enterotoxige Escherichia coli (E. coli) recombinant active vaccine FE3 and FE16.

METHODSToxicity and immunogenicity of the vaccine were determined by experiments on enterotoxigenic E. coli toxicity and immunological experiments on rabbits and mice.

RESULTSThe results of an toxicological experiments were negative. The agglutination titer of antibodies against the S. flexneri 2a and enterotoxigenic E. coli plamid antigen were all higher than 1:640 and 1:1280 in the sera of rabbits. IgG in the serum went up remarkably, while sIgA against CFA/I was also decteted in the dejecta of mice immunized with active bacteria either orogastrically or intranasally. Simultaneously, sIgA was not detected in the dejecta of mice immunized with inactive bacteria either orogastrically or intranasally.

CONCLUSIONThe enterotoxigenic E. coli recombinant active vaccine showed good safety and immunogenicity, inducing both humoral and mucosal immunity in mice.

Administration, Intranasal ; Administration, Oral ; Agglutination ; immunology ; Animals ; Bacterial Vaccines ; administration & dosage ; adverse effects ; immunology ; Drug-Related Side Effects and Adverse Reactions ; immunology ; Enterotoxigenic Escherichia coli ; immunology ; Female ; Immunoglobulin A ; blood ; immunology ; Immunoglobulin G ; blood ; immunology ; Mice ; Rabbits ; Vaccines, Synthetic ; administration & dosage ; adverse effects ; immunology

OBJECTIVETo investigate immunity of a recombinant adenovirus vaccine (rAdV) containing codon-modified neuraminidase (Mod. NA) gene of H5N1 influenza virus in BALB/c mice and to screen for appropriate dose.

METHODSBALB/c mice were immunized with the rAdV-Mod.NA vaccine intramuscularly twice (double injection at 0 and 4th week) in three groups, low dosage (10(5) TCID50 per dose), medium dosage (10(7) TCID50 per dose) and high dosage (10(9) TCID50 per dose). The effect of humoral and cell-mediated immunity were analysed at 5th week.

RESULTS(1) The rAdV-Mod.NA vaccine could elicit both humoral and cell-mediated robust NA specific immunity in mice by neuraminidase inhibitor assay and IFN-gamma ELISpot assay; (2) 10(7) TCID50 per dose was the appropriate dose; (3) Peptide NA(109-124): CRTFFLTQGALLNDKH and peptide NA(182-199): AVAVLKYNGIITDTIKSW were the dominant epitopes for neuraminidase-immunized BALB/c mice, which was screened out from the whole length of neuraminidase of an H5N1 virus, A/Anhui/1l/2005.

CONCLUSIONThe recombinant adenovirus NA could induce specific humoral and cellular immune responses in BALB/c after immunization, which suggest rAdV-Mod.NA vaccine was a potential vaccine candidate against H5N1 influenza and worthy of further investigation.

Adenoviridae ; genetics ; metabolism ; Animals ; Dose-Response Relationship, Immunologic ; Female ; Gene Expression ; Genetic Vectors ; genetics ; metabolism ; Humans ; Influenza A Virus, H5N1 Subtype ; genetics ; immunology ; Influenza Vaccines ; administration & dosage ; genetics ; immunology ; Influenza, Human ; immunology ; prevention & control ; virology ; Mice ; Mice, Inbred BALB C ; Neuraminidase ; administration & dosage ; genetics ; immunology ; Random Allocation ; Vaccines, Synthetic ; administration & dosage ; genetics ; immunology ; Viral Proteins ; administration & dosage ; genetics ; immunology