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

Author(s):  
Marília Dalva TURCHI ◽  
Celina Maria Turchi MARTELLI ◽  
Maria Lúcia FERRAZ ◽  
Antonio Eduardo SILVA ◽  
Divina das Dores de Paula CARDOSO ◽  
...  

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

2003 ◽  
Vol 98 (8) ◽  
pp. 1101-1107 ◽  
Author(s):  
José Luís da S Baldy ◽  
Maria do Carmo M Elisbão ◽  
Edson T Anzai ◽  
Rubens Pontello ◽  
Edna Maria V Reiche ◽  
...  

2000 ◽  
Vol 21 (4) ◽  
pp. 264-269 ◽  
Author(s):  
Elizabeth A. Henderson ◽  
Thomas J. Louie ◽  
Karam Ramotar ◽  
Donna Ledgerwood ◽  
Karen Myrthu Hope ◽  
...  

Objective.To compare the immunogenicity of hepatitis B vaccine administered via intradermal (ID) versus intramuscular (IM) route.Methods:Subjects chose either to specify the route of immunization or to undergo random allocation to vaccination by the ID (0.15 mL) or the IM (1.0 mL) route. Yeast-derived recombinant hepatitis B vaccine was given at 0, 30, and 180 days. Hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) were measured by microparticle enzyme immunoassay.Results:763 subjects were enrolled. Baseline screening identified 65 subjects (8%) who were positive for HBsAb or HBcAb. Vaccination was completed by 590 (85%) of 698 enrollees (370 ID, 220 IM). Seroconversion rates (geometric mean titers [GMT]>0 IU/mL HBsAb) for those vaccinated ID were 99% and 96% for screening at 9 months and 1 year post-vaccination, respectively; subjects vaccinated intramuscularly had similar rates of 95% and 96%. Seropositivity rates (GMT ≥ 10 IU/mL HBsAb) showed a similar pattern, with 95%, 92%, and 73% at 9 months and 1 and 2 years, respectively, for those vaccinated ID, and 94%, 93%, and 81% for those having IM vaccination. GMT for HBsAb was significantly higher for individuals vaccinated IM than for those vaccinated ID (P<.0001). The GMT ratio for the IM and ID routes decreased over time, being 9.3 at 9 months, 7.8 at 1 year, and 5.9 at 2 years. An unanticipated side effect of intradermal vaccination was skin discoloration at injection sites, which persisted for at least 2 years postvaccination. Two thirds (112/166) of respondents reported that they would have selected the ID route despite the discoloration.Conclusions:Higher-dose ID vaccination (3 vs 1 μg per injection) uses one sixth of the dose required for standard IM vaccination. It is a cost-effective way to vaccinate populations against hepatitis B virus, but the long-term efficacy of the ID route must still be investigated.


2002 ◽  
Vol 23 (2) ◽  
pp. 87-90 ◽  
Author(s):  
E. Geoffrey Playford ◽  
Patrick G. Hogan ◽  
Amolak S. Bansal ◽  
Kareena Harrison ◽  
David Drummond ◽  
...  

Objective:To study the humoral immune responses, safety, and tolerability of intradermal recombinant hepatitis B vaccination in healthcare workers (HCWs) nonresponsive to previous repeated intramuscular vaccination.Design:An open, prospective, before–after trial.Setting:A tertiary referral hospital and surrounding district health service in Queensland, Australia.Participants:Hospital and community HCWs nonresponsive to previous intramuscular hepatitis B vaccination.Methods:Intradermal recombinant hepatitis B vaccine was administered every second week for a maximum of 4 doses. Hepatitis B surface antibody (anti-HBs) responses were assessed 2 weeks after each dose.Results:Protective anti-HBs levels developed in 17 (94%) of 18 study subjects. Three doses resulted in seroconversion of all responding subjects and the highest geometric mean antibody concentration. The vaccine was well tolerated.Conclusion:More than 90% of previously nonresponsive HCWs responded to intradermal recombinant hepatitis B vaccine with protective anti-HBs levels.


1988 ◽  
Vol 16 (3) ◽  
pp. 231-236 ◽  
Author(s):  
F. Ichida ◽  
A. Yoshikawa ◽  
M. Mizokami ◽  
M. Yamamoto ◽  
N. Inaba ◽  
...  

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.


Vaccine ◽  
1991 ◽  
Vol 9 (10) ◽  
pp. 747-750 ◽  
Author(s):  
Giuseppe Giammanco ◽  
Salvatore Li Volti ◽  
Luisa Mauro ◽  
Giuseppe Giammanco Bilancia ◽  
Isabella Salemi ◽  
...  

Health Scope ◽  
2022 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Alireza Bakhshipour ◽  
Manijeh Khalili ◽  
Raheleh Rafaiee

Background: Hepatitis B virus (HBV) is a severe public health problem in Iran. This study was conducted to investigate the intrafamilial transmission of HBV in vaccinated children whose one or both parents were positive for hepatitis B surface antigen (HBsAg). Methods: In a study with retrospective cohort design, 110 exposed cases with HBsAg-positive parent(s) were compared with 110 unexposed controls of the same sex and age groups. The participants were directly asked about demographic characteristics, medical history, and vaccinations. Blood samples were collected and analyzed for HBV infection markers using the ELIZA method. Results: Overall, 1.8% HBsAg (P = 0.15) and 13.6% hepatitis B core antibody (HBcAb) (P < 0.0001) positivity rates were detected in the exposed group. The hepatitis B surface antibody titer (HBsAb) showed that 34.5% of cases and 56.3% of controls had HBsAb levels > 10 IU/L. There was a significant difference in the protective HBsAb level between the two groups (P < 0.0001). There were significant associations between HBsAb level and gender in the exposed group and decreased HBsAb levels and age. Conclusions: The high rate of positive HBcAb and HBsAg and decreasing HBsAb levels with age in this study indicate that routine childhood vaccination programs are inadequate in preventing HBV transmission and vaccine routes changing or further booster vaccination is essential. Effective case finding in vaccinated children with HBsAg-positive parents, intradermal vaccination, and hepatitis B immunoglobulin in newborns with HBsAg-positive fathers are suggested.


Author(s):  
C.R.B. Ferreira ◽  
C.F.T. Yoshida ◽  
L.A.C. Mercadante ◽  
D.F. Gomes ◽  
J.M. Oliveira ◽  
...  

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.


1970 ◽  
Vol 11 (2) ◽  
pp. 143-150 ◽  
Author(s):  
Abhijit Guho ◽  
Md Abdul Ahad ◽  
Md Abdus Salam ◽  
Md Abdul Alim ◽  
AKM Enamul Haque ◽  
...  

Background: Hepatitis B virus infection is an important public health problem with significant morbidity andmortality. Recombinant hepatitis B vaccine for the prevention of hepatitis B virus infection is in practice in differentparts of the world since its availability in 1986. Government of Bangladesh has also included hepatitis B vaccine inEPI schedule since 2005.Materials and methods: This study was carried out to assess the seroconversion status among hepatitis Bvaccinated individuals. A total of 190 individuals including 150 vaccinated persons and 40 non-vaccinated apparentlyhealthy individuals were included as study population. Sources of vaccinated persons were from both EPI and non-EPI schedule of vaccination. Age and sex matched non-vaccinated individuals served as controls for the study. Allindividuals constituting the study population were screened for HBsAg by Immunochromatographic strip test andonly HBsAg-negative persons were included for estimation of their anti-HBs titer.Results: Out of 150 vaccinated individuals, 133(88.67%) were found to have anti-HBs titer in the protective level(>10 IU/L), while 17(11.33%) individuals had anti-HBs titer below the protective level (<10 IU/L). All non-vaccinatedcontrols had anti-HBs titers below the protective level. Regarding immune response developed among vaccinatedindividuals, 67.78%, 23.33% and 8.89% were good-responders, hypo-responders and non-responders respectively.Mean titer of anti-HBs was found significantly higher among recipients who received booster dose than those whoreceived 3 doses schedule (863.39 IU/L vs. 262.40 IU/L), indicating high antibody titer develops after booster dose.Vaccinated group included 85 (56.67%) men and 65 (43.33%) women with protective level of anti-HBs titer foundin 85.88% male and 92.31% female individuals. There was no significant difference of anti-HBs titer between maleand female (p>0.05). Vaccinated individuals from lower socioeconomic condition have had comparatively low rateof protective antibody than people from middle and upper classes.Conclusion: Recombinant HB vaccine induces good level of protective immunity among vaccinated persons.Keywords: Hepatitis B; hepatitis B vaccine; seroconversion; BangladeshDOI: 10.3329/jom.v11i2.5461J MEDICINE 2010; 11 : 143-150


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