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REPORTE CORTO/SHORT REPORT Presented in the Congress Biotecnologia Habana 94. La Habana, Cuba, Nov. 28 - Dec. 3, 1994 THE HEPATITIS B VIRUS (HBV) INFECTION AND ITS PREVENTION BY A RECOMBINANT-DNA VIRAL SURFACE ANTIGEN (rec-HBsAg) VACCINE
Eduardo Penton , Martha Gonzalez, and Verena Muzio.
Center for Genetic Engineering and Biotechnology. P.O. Box 6162, Havana, Cuba.
INTRODUCTION
This paper contains an updated review of the main aspects related to the development and characterization of a yeast-derived rec- HBsAg, which was directly followed by the scale-up production as well as the quality assurance and control of the corresponding vaccine, under GMP and GLP standard procedures. Pre-clinical experiencies were carried out in animal models (including the HBV-challenging of immunized and control chimpanzees) and clinical trials were performed by (or archieved in agreement with) health authorities in Cuba and several countries. Double- blind controlled three phase protocols, according to strict ethical and methodological guidelines for clinical trials, demonstrated at least a similar and more often a better performance for the Cuban vaccine than parallel immunizations with other commercially available rec-HBsAg vaccines. These results enabled the patent application and sanitary registration followed by commercialization of millions of doses of the product in more than 15 countries since 1990. Hundreds of thousands of peoples of different ages, sexes and sexual behaviours, geographic areas and nationalities, ethnical groups and occupations, life styles and risk of exposition, social and economical levels, received the Cuban rec-HBsAg vaccine, including controlled studies and vaccination campaigns in Cuba and abroad (see table). The first vaccination program in America, including the complete populations of newborn and children up to one year old, primary and secondary schoool children and high infection risk groups, is currently ongoing in Cuba using this vaccine. The program envisages the vaccination of the whole Cuban population under 20 before the year 2 000.
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Controled
Studies Rt Age Vac./Dose(ug) N SRC GMT S.E.
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Cuban CV10 86 94-100 90-280 *
Health workers IM 20-46 CV20 15 94-100 110-520 **
0
SK20 95 87-100 30-60 *
(HW) and patients CV10 43 100 150-350 ***
contacts (PC) SC 20-46 CV20 43 100 250-400 ***
0-1-2 months SK20 46 91-94 20-30 **
Cuban CV10 20 100 2e^3 **
HW and PC IM 38 CV20 15 100 >1e^4 ***
0-1-6 months SK20 17 100 1.5e^3 **
HW and PC IM adults CV20 80 97-100 51-98^a **
in 5 countries^b 5
0-1-2 SK20 59 87 11^a *
ID 23 CV2 43 93 39^a *
Idem IM adults CV20 10 100 93-95^A **
7
SK20 59 98 48^a **
Children IM 0c CV10 15 92-96 360-440 *
7
Havana 0-1-2 SK10 23 89 53 *
Havana 0-1-6 IM 2-12 CV10 14 100 5e^3- 17e^3*
3
Moscow 0-1-2 IM 0.5-10 CV10 60 95 83^a *
Bogota 0-1-2 IM 1-10 CV10 58 100 100^a na
Aged prs^d.
0-1-6 IM 81 CV20 52 100 78^a **
Soldiers: SK20 63 92-100 90-720 **
Cuban 0-1-2 IM 19-26 CV20 12 95-100 500-1 e^3 **
3
Russian 0-1-3 20 CV20 14 95 95^a *
6
African st^e
0-1-2 IM 14-21 CV20 245 98 96^a *
Indians^f
0-1-2 IM adults CV20 60 93-100 73-75^a n.a.
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Rt=Route; IM, SC, ID=Intramuscular, subcutaneous, intradermal;
Age=Age in years (mean or range); N=Number of persons;
SRC=Seroconversion (%); GMT=Geometric mean or range of titers
(IU/L); ex=10x; CV2, 10, 20=Cuban vaccine 2, 10, 20 mg per dose;
SK 10, 20=Commercial vaccine 10, 20 mg per dose; S.E.=Side
effects: *** 20-40%, ** 10-20%, < 10% with symptoms; n.a.= not
available; a (column 7)=% with titers > 99.9 IU/L; b Colombia,
Brazil, Peru, Venezuela and Viet-Nam; c Neonates from HBV
infected mothers; d Cubans; estudents; f mestizos from South
America.Copyright 1995 Sociedad Iberolatinoamericana de Biotecnologia Aplicada a la Salud
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