Clinical evaluation in healthy adults of a hepatitis B vaccine made by recombinant DNA

JAMA ◽  
1984 ◽  
Vol 251 (21) ◽  
pp. 2812-2815 ◽  
Author(s):  
E. M. Scolnick
Vaccine ◽  
1991 ◽  
Vol 9 (10) ◽  
pp. 747-750 ◽  
Author(s):  
Giuseppe Giammanco ◽  
Salvatore Li Volti ◽  
Luisa Mauro ◽  
Giuseppe Giammanco Bilancia ◽  
Isabella Salemi ◽  
...  

Vaccine ◽  
1992 ◽  
Vol 10 (5) ◽  
pp. 301-304 ◽  
Author(s):  
G. Söyletir ◽  
E. Bahçeci ◽  
E. Akoğlu ◽  
U. Soyoğul ◽  
R.A. Lawrance

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


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.


2015 ◽  
Vol 11 (7) ◽  
pp. 1709-1716 ◽  
Author(s):  
Rajiv Sharma ◽  
Clas Ahlm ◽  
Lars Ostergaard ◽  
Anthony Dowell ◽  
Clément Tran ◽  
...  

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