Clinical Study of Recombinant Hepatitis B Vaccine

1988 ◽  
Vol 16 (3) ◽  
pp. 231-236 ◽  
Author(s):  
F. Ichida ◽  
A. Yoshikawa ◽  
M. Mizokami ◽  
M. Yamamoto ◽  
N. Inaba ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Effective Dose ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Hepatitis B Vaccine ◽  
Efficacy And Safety ◽  
The Third ◽  
Antibody Titres

The efficacy and safety of a recombinant yeast-derived hepatitis B vaccine were evaluated in 209 subjects after three administrations at 0, 4 and 20 weeks. Subjects were divided into four groups given 5 μg vaccine subcutaneously, 10 μg subcutaneously, 10 μg intramuscularly and 20 μg subcutaneously to define the effective dose and to compare the effect of administration. Seroconversion of the antibody to hepatitis B surface antigen after the third vaccination reached 96.6 % in the group given 5 μg vaccine subcutaneously and 100% in the other groups. The final geometric mean antibody titres were 700 IU/1 in subjects given 5 μg subcutaneously, 2004 IU/1 in those given 10 μg subcutaneously, 4674 IU/1 in those given 10 μg intramuscularly and 3342 IU/1 in those given 20 μg subcutaneously. In the groups given 10 μg, the early seroconversion rate of the antibody to hepatitis B surface antigen and the geometric mean antibody titres after the third vaccination were significantly higher in subjects administered intramuscularly than subcutaneously ( P<0.05). No major adverse effects were observed and minor reactions were the same as, or less than, those reported for the plasma-derived vaccine. Before and after administration, no significant fluctuation in the yeast antibody titre was observed. These results demonstrate the efficacy and safety of the yeast-derived vaccine, and show that 10 μg was the effective dose.

scholarly journals Doses of hepatitis B revaccination needed for the seronegative youths to be seropositive to antibody against hepatitis B surface antigen

2019 ◽  
Author(s):  
Chyi-Feng Jan ◽  
Tzu-Hung Liu ◽  
Chien-Han Ho ◽  
Yin-Chu Chien ◽  
Che-Jui Chang ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Graduate School ◽  
Hepatitis B Surface Antigen ◽  
Hepatitis B Vaccine ◽  
School Students ◽  
College Entrance ◽  
School Entrance ◽  
Vaccine Booster ◽  
Antibody Titres

Abstract Objectives To determine the required hepatitis B vaccine doses for subjects who were seronegative for three hepatitis B seromarkers during their youth who wish to have seroprotective antibodies against the hepatitis B surface antigen (anti-HBs). Methods We conducted a retrospective cohort study. From 2012 to 2015, graduate school students born after 1986 who were seronegative for three hepatitis B virus seromarkers at college entrance (n = 1037) were recruited. Four groups of subjects received zero to three doses of a hepatitis B vaccine booster at their free willingness, and their anti-HBs titre were measured at their graduate school entrance. Very low and extremely low antibody titres against the hepatitis B surface antigen were elucidated by graphic inference to determine the required booster dose cut-off value for seropositivity after revaccination. Results The anti-HBs seropositive rates in the four groups of subjects receiving the hepatitis B booster vaccine(s) were 17.7%, 52.1%, 78.6% and 90.9% for those receiving zero, one, two and three doses, respectively. In subjects with very low antibody titres against the hepatitis B surface antigen after one dose of the vaccine booster and subjects with an extremely low titre after two doses of the booster, the seropositive rates reached 95% at the cut-off value of 3 mIU/ml. Conclusion A seropositive rate of at least 95% can be reached by the administration of two hepatitis B booster doses to youths with extremely low antibody titres against the hepatitis B surface antigen (<3 mIU/ml) and administering one dose to those with very low titres (3–10 mIU/ml) at college.

Hepatitis B Vaccine in Healthy Hospital Employees

1986 ◽  
Vol 7 (7) ◽  
pp. 365-369 ◽  
Author(s):  
S.A Klotz ◽  
R. Normand ◽  
R. Silberman
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Response Rate ◽  
Hepatitis B Surface Antigen ◽  
Hepatitis B Vaccine ◽  
Protective Level ◽  
Entire Series ◽  
Hospital Employees ◽  
Lower Response Rate ◽  
Low Rate

AbstractA low rate of seroconversion to hepatitis B vaccine is reported. This occurred in healthy hospital employees from two separate institutions. A total of 236 individuals were evaluated in this study and only 53% or 124 persons developed protective levels of antibody to hepatitis B surface antigen following a complete vaccine series. In one hospital, 30% of the vaccine recipients developed antibody but not to a protective level. Employees who received the entire series in the arm or in the arm and buttock (mixed) had a significantly greater number of responders than employees who received the entire series in the buttock (P<.05). Recipients aged 50 to 59 years had a significantly lower response rate to the vaccine (P<.05). There was no correlation with the vaccinee's sex or the timing of the second injection. Vaccine was noted to have frozen in one hospital and accounted for some loss of antigenicity. This failure to respond to the vaccine has necessitated the use of booster injections of vaccine and continued antibody monitoring.

scholarly journals IMMUNOGENICITY OF LOW-DOSE INTRAMUSCULAR AND INTRADERMAL VACCINATION WITH RECOMBINANT HEPATITIS B VACCINE

1997 ◽  
Vol 39 (1) ◽  
pp. 15-20 ◽  
Author(s):  
Marília Dalva TURCHI ◽  
Celina Maria Turchi MARTELLI ◽  
Maria Lúcia FERRAZ ◽  
Antonio Eduardo SILVA ◽  
Divina das Dores de Paula CARDOSO ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Recombinant Dna ◽  
Standard Dose ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Hepatitis B Vaccine ◽  
Antibody Concentration ◽  
Intradermal Vaccination ◽  
Group I ◽  
Significant Difference

The study is a randomized trial using recombinant DNA vaccine to determine whether an intramuscular 10 µg dose or intradermal 2 µg induces satisfactory anti-HBs levels compared to the standard dose of intramuscular 20 µg. participants were 359 healthy medical and nurse students randomly allocated to one of the three groups: Group I - IM 20 µg; Group II - IM 10 µg; Group III - ID 2 µg at 0, 1 and 6 months. Anti-HBs titres were measured after complete vaccine schedule by ELISA/Pasteur. Baseline variables were similar among groups and side effects were mild after any dose. Vaccinees in the IM-10 µg group had seroconversion rate and geometric mean titre (GMT 2344 IU L-1), not significant different from the IM-20 µg group (GMT 4570 IU L-1). On the contrary, 21.4% of the ID - 2 µg recipients mount antibody concentration below 10 IU L1 and GMT of 91 IU L-1, a statiscally significant difference compared with the standard schedule IM-20 µg (p < 0.001). A three dose regimen of half dosse IM could be considered an appropriate schedule to prevent hepatitis B in young health adults which is of relevance to the expansion of hepatitis B vaccine programme

scholarly journals Immunization aganist hepatitis B in children from endemic zone: evaluation of the antibody response against the DNA recombinant vaccine (Engerix B-20 mcg)

1993 ◽  
Vol 35 (1) ◽  
pp. 89-92 ◽  
Author(s):  
C.R.B. Ferreira ◽  
C.F.T. Yoshida ◽  
L.A.C. Mercadante ◽  
D.F. Gomes ◽  
J.M. Oliveira ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Antibody Response ◽  
Recombinant Dna ◽  
Hepatitis B Surface Antigen ◽  
Vaccine Dose ◽  
Vaccination Schedule ◽  
Hepatitis B Vaccine ◽  
Recombinant Hepatitis ◽  
The Third ◽  
Rural Zone

A previous seroepidemiological study in the rural zone of Vargem Alta (ES) SouthEast of Brazil, showed a prevalence of up to 9% of hepatitis B surface antigen (HBsAg) in some areas. One hundred susceptible children aging 1 to 5 years old were selected and immunized with a recombinant DNA hepatitis B vaccine (Smith-Kline 20 mcg) using the 0-1-6 months vaccination schedule. Blood samples were collected at the time of the first vaccine dose (month 0) in order to confirm susceptible individuals and 1,3,6 and 8 months after the first dose , to evaluate the antibody response. Our results showed that two and five months after the second dose, 79% and 88% of children seroconverted respectively, reaching 97% after the third dose. The levels of anti-HBs were calculated in milli International Units/ml (mIU/ml) and demonstrated the markedly increase of protective levels of antibodies after the third dose. These data showed a good immunogenicity of the DNA recombinant hepatitis B vaccine when administered in children of endemic areas.

Duration of Response to Intramuscular Versus Low Dose Intradermal Hepatitis B Booster Immunization

1991 ◽  
Vol 12 (4) ◽  
pp. 226-230 ◽  
Author(s):  
W. Paul McKinney ◽  
Susan K. Russler ◽  
Mary M. Horowitz ◽  
Richard J. Battiola ◽  
Martha Bi-Fong Lee
Keyword(s):  
Hepatitis B ◽  
Hepatitis B Surface Antigen ◽  
Geometric Mean ◽  
Hepatitis B Vaccine ◽  
Cross Sectional ◽  
Booster Immunization ◽  
Booster Vaccine ◽  
Metropolitan County ◽  
Duration Of Response ◽  
Group 2

AbstractObjective:To determine the duration of the immune response to plasma-derived hepatitis B vaccine among healthcare workers responding to booster doses of intradermal (ID) or intramuscular (IM) vaccine in 1986 and those with protective levels of antibody to hepatitis B surface antigen (anti-HBs) in 1986 without booster vaccine. Both groups received a primary hepatitis B vaccine series 24 to 36 months earlier.Design:Cross-sectional follow-up study two years later of an inception cohort defined in 1986.Setting:An academically affiliated metropolitan county hospital.Participants:Group 1: Hospital employees responding to booster doses of hepatitis B vaccine given ID or IM in 1986 due to low anti-HBs levels. Forty-one (82%) of 50 eligible persons were evaluated. Group 2: Persons not receiving booster vaccine in 1986 due to protective levels of anti-HBs. A random sample of 95 persons was drawn from a pool of 152 participants with protective levels in 1986. sixty-five (68%) of 95 contacted persons were restudied.Results:In 1988, 14 (64%) of 22 previous ID responders had anti-HBs levels ≥ 10 milli-international units (mIU)/mL, compared with 17 (89%) of 19 IM responders (p= .055). The 1988 geometric mean titer of IM recipients was 66.4 ±4.5 mIU/mL and of ID recipients was 20.7 ±7.4 (p= .04). None of 65 Group 2 subjects' anti-HBs titers dropped below 10 mIU/mL by 1988.Conclusions:plasma-derived hepatitis B vaccine recipients with anti-HBs levels ≥ 10 mIU/mL at 24 to 36 months after primary immunization are likely to maintain these levels two years later. The diminished durability of the antibody response together with the increased rate of local side effects associated with the ID injection route may limit its applicability as an alternative to using IM booster doses of hepatitis B vaccine.

scholarly journals Development and Technical and Clinical Validation of a Quantitative Enzyme-Linked Immunosorbent Assay for the Detection of Human Antibodies to Hepatitis B Surface Antigen in Recipients of Recombinant Hepatitis B Virus Vaccine

2009 ◽  
Vol 16 (8) ◽  
pp. 1236-1246 ◽  
Author(s):  
Pierre Cambron ◽  
Jeanne-Marie Jacquet ◽  
Bernard Hoet ◽  
Marc Lievens
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Immunosorbent Assay ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Analytical Sensitivity ◽  
Limit Of Quantitation ◽  
B Virus

ABSTRACT Pending removal from the market of a commercial assay (the AUSAB [Abbott Laboratories] enzyme immunoassay [EIA]) for the determination of antibodies to hepatitis B surface antigen (HBsAg), a new in-house quantitative enzyme-linked immunosorbent assay (ELISA) to measure antibodies against HBsAg (anti-HBs) was developed (anti-HBs in-house). Specific anti-HBs antibodies were sandwiched between the precoated HBsAg ad and ay subtypes purified from plasma from hepatitis B virus (HBV) human carriers and the recombinant HBsAg adw2 subtype tagged with horseradish peroxidase. The assay was calibrated against the 1st International Reference Preparation for anti-hepatitis B immunoglobulin (lot 1977-W1042). Analytical sensitivity and the limit of quantitation were estimated at 0.43 mIU/ml and 2.0 mIU/ml, respectively. Overall reproducibility was 11.86%, and accuracy was estimated to be 94.89%. More than 4,000 samples from seven clinical trials were tested with the anti-HBs in-house assay and compared to results generated with AUSAB EIA and AUSAB radioimmunoassay (RIA). During the technical validation, the anti-HBs in-house assay was compared to the AUSAB RIA as a reference (n = 919). Overall assessment of concordance and Deming's regression analysis were performed. The coefficient of correlation between the AUSAB RIA and anti-HBs in-house assay was 0.9815 with a slope of 0.9187. The overall agreement between anti-HBs in-house and AUSAB RIA was 97.61%, considering the clinical cutoffs at 3.3 mIU/ml and 1.0 mIU/ml for the respective assays. From a clinical perspective, seroprotection rates and anti-HBs geometric mean antibody concentrations for individual studies calculated with either the in-house assay or the reference assays were similar. Conclusions of individual studies were confirmed. The performance characteristics of the in-house assay are acceptable. There is no evidence that use of the new assay would lead to different clinical conclusions from the reference method.

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