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May 15, 1987, Vol 257, No. 19 >
ARTICLE | May 15, 1987

Yeast-Recombinant Hepatitis B Vaccine: Title and subTitle BreakEfficacy With Hepatitis B Immune Globulin in Prevention of Perinatal Hepatitis B Virus Transmission FREE

Cladd E. Stevens, MD; Patricia E. Taylor, PhD; Myron J. Tong, MD; Pearl T. Toy, MD; Girish N. Vyas, PhD; Prem V. Nair, MD; Joy Y. Weissman, MD; Saul Krugman, MD
[+] Author Affiliations

Reprint requests to The New York Blood Center, 310 E 67th St, New York, NY 10021 (Dr Stevens).


JAMA. 1987;257(19):2612-2616. doi:10.1001/jama.1987.03390190090026
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Article
References

A yeast-recombinant hepatitis B vaccine was licensed recently by the Food and Drug Administration and is now available. To assess the efficacy of the yeast-recombinant vaccine, we administered the vaccine in combination with hepatitis B immune globulin to high-risk newborns. If infants whose mothers were positive for both hepatitis B surface antigen and the e antigen receive no immunoprophylaxis, 70% to 90% become infected with the virus, and almost all become chronic carriers. Among infants in this study who received hepatitis B immune globulin at birth and three 5-ÎĽg doses of yeast-recombinant hepatitis B vaccine, only 4.8% became chronic carriers, a better than 90% level of protection and a rate that is comparable with that seen with immune globulin and plasmaderived hepatitis B vaccine. These data suggest that, in this high-risk setting, the yeast-recombinant vaccine is as effective as the plasma-derived vaccine in preventing hepatitis B virus infection and the chronic carrier state.

(JAMA 1987;257:2612-2616)

REFERENCES

1 +
Valenzuela P, Gray P, Quiroga M, et al:  Nucleotide sequence of the gene coding for the major protein of hepatitis B virus surface antigen . Nature 1979;;280:815-819.
2 +
Edman JC, Hallewell RA, Valenzuela P, et al:  Synthesis of hepatitis B surface and core antigens  in E coli. Nature 1981;;291:503-506.
3 +
McAleer WJ, Buynak EB, Maigetter RZ, et al:  Human hepatitis B vaccine from recombinant yeast . Nature 1984;;307:178-180.
4 +
Wampler DE, Lehman ED, Boger J, et al:  Multiple chemical forms of hepatitis B surface antigen produced in yeast . Proc Natl Acad Sci USA 1985;;82:6830-6834.
5 +
Emini EA, Ellis RW, Miller WJ, et al:  Production and immunological analysis of recombinant hepatitis B vaccine . J Infect 1986;;13( (suppl A) ):3-9.
6 +
Jilg W, Lorbeer B, Schmidt M, et al:  Clinical evaluation of a recombinant hepatitis B vaccine . Lancet 1984;;2:1174-1175.
7 +
Davidson M, Krugman S:  Immunogenicity of recombinant yeast hepatitis B vaccine . Lancet 1985;;1:108-109.
8 +
Papaevangelou G, Dandolos E, Roumeliotou-Karayannis A, et al:  Immunogenicity of recombinant hepatitis B vaccine . Lancet 1985;;1:455-456.
9 +
Brown SE, Stanley C, Howard CR, et al:  Antibody responses to recombinant and plasma-derived hepatitis B vaccines . Br Med J 1986;;292:159-161.
10 +
Hollinger FB, Troisi CL, Pepe PE:  Anti-HBs responses to vaccination with a human hepatitis B vaccine made by recombinant DNA technology in yeast . J Infect Dis 1986;;153:156-159.
11 +
Alter MJ, Favero MS, Maynard JE:  Impact of infection control strategies on the incidence of dialysis-associated hepatitis in the United States . J Infect Dis 1986;;153:1149-1151.
12 +
Stevens CE, Alter HJ, Taylor PE, et al:  Hepatitis B vaccine in patients receiving hemodialysis: Immunogenicity and efficacy . N Engl J Med 1984;; 311:496-501.
13 +
Stevens CE, Taylor PE, Zang EA, et al:  Human T-cell lymphotropic virus type III infection in a cohort of homosexual men in New York City . JAMA 1986;;255:2167-2172.
14 +
 Recommendations for protection against viral hepatitis . MMWR 1985;;34:313-335.
15 +
Hollinger FB, Adam E, Heiberg D, et al:  Response to hepatitis B vaccine in a young adult population , in Szmuness W, Alter HJ, Maynard JE (eds): Viral Hepatitis: 1981 International Symposium . Philadelphia, The Franklin Institute Press, 1982;, pp 451-466.
16 +
Stevens CE, Toy PT, Tong MJ, et al:  Perinatal hepatitis B virus transmission in the United States: Prevention by passive-active immunization . JAMA 1985;;253:1740-1745.
17 +
Beasley RP, Hwang L-Y, Lee GC-Y, et al:  Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine . Lancet 1983;;2:1099-1102.
18 +
Snedecor GW, Cochran WG: Statistical Methods . Ames, Iowa State University Press, 1971;.
19 +
Schweitzer IL, Wing A, McPeak C, et al:  Hepatitis and hepatitis-associated antigen in 56 mother-infant pairs . JAMA 1972;;220:1092-1095.
20 +
Okada K, Yamada T, Miyakawa Y, et al:  Hepatitis B surface antigen in the serum of infants after delivery from asymptomatic carrier mothers . J Pediatr 1975;;87:360-363.
21 +
Stevens CE, Beasley RP, Tsui J, et al:  Vertical transmission of hepatitis B antigen in Taiwan . N Engl J Med 1975;;292:771-774.
22 +
Lee AKY, Ip HMH, Wong VCW:  Mechanisms of maternal-fetal transmission of hepatitis B virus . J Infect Dis 1978;;138:668-671.
23 +
Tong MJ, Thursby M, Rekela J, et al:  Studies on the maternal-infant transmission of the viruses which cause acute hepatitis . Gastroenterology 1981;;80:999-1004.
24 +
Okada K, Kamiyama I, Inomata M, et al:  e Antigen and anti-e in the serum of asymptomatic carrier mothers as indicators of positive and negative transmission of hepatitis B virus to their infants . N Engl J Med 1976;;294:647-649.
25 +
Beasley RP, Trepo C, Stevens CE, et al:  The e antigen and vertical transmission of hepatitis B surface antigen . Am J Epidemiol 1977;;105:94-98.
26 +
Ohbayashi A:  Genetic and familial aspects of liver cirrhosis and hepatocellular carcinoma , in Okuda K, Peters RL (eds): Hepatocellular Carcinoma . New York, John Wiley & Sons Inc, 1976;, pp 43-51.
27 +
Larouze B, London WT, Saimot G, et al:  Host responses to hepatitis-B infection in patients with primary hepatic carcinoma and their families: A case/control study in Senegal, West Africa . Lancet 1976;;2:534-538.
28 +
Beasley RP, Hwang L-Y, Lin C-C, et al:  Hepatocellular carcinoma and hepatitis B virus: A prospective study of 22 707 men in Taiwan . Lancet 1981;;2:1129-1133.
29 +
Kew MC, Fujita Y, Takahashi H, et al:  Comparison between polyclonal and first and second generation monoclonal radioimmunoassays in the detection of hepatitis B surface antigen in patients with hepatocellular carcinoma . Hepatology 1986;;6: 636-639.
30 +
Beasley RP, Hwang L-Y, Stevens CE, et al:  Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo-controlled trial . Hepatology 1983;;3:135-141.
31 +
Hwang L-Y, Beasley RP, Lee GC-Y, et al:  Prevention of perinatally transmitted hepatitis B virus infection with hepatitis B immune globulin and/or HB vaccine , in Vyas GN, Dienstag JL, Hoofnagle JH (eds): Viral Hepatitis and Liver Disease . Orlando, Fla, Grune & Stratton, 1984;, pp 678-679.
32 +
Wong VCW, Ip HMH, Reesink HW, et al:  Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin: Double-blind randomised placebo-controlled study . Lancet 1984;;1:921-926.
33 +
Lo K-J, Tsai Y-T, Lee S-D, et al:  Immunoprophylaxis of infection with hepatitis B virus in infants born to hepatitis B surface antigen-positive carrier mothers . J Infect Dis 1985;;152:817-822.
34 +
Xu Z-Y, Liu C-B, Francis DP, et al:  Prevention of perinatal acquisition of hepatitis B virus carriage using vaccine: Preliminary report of a randomized, double-blind placebo-controlled and comparative trial . Pediatrics 1985;;76:713-718.
35 +
Neurath AR, Kent SBH:  The pre-S region of hepadnavirus envelope proteins . Ad Virus Res , in press.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Valenzuela P, Gray P, Quiroga M, et al:  Nucleotide sequence of the gene coding for the major protein of hepatitis B virus surface antigen . Nature 1979;;280:815-819.
2 +
Edman JC, Hallewell RA, Valenzuela P, et al:  Synthesis of hepatitis B surface and core antigens  in E coli. Nature 1981;;291:503-506.
3 +
McAleer WJ, Buynak EB, Maigetter RZ, et al:  Human hepatitis B vaccine from recombinant yeast . Nature 1984;;307:178-180.
4 +
Wampler DE, Lehman ED, Boger J, et al:  Multiple chemical forms of hepatitis B surface antigen produced in yeast . Proc Natl Acad Sci USA 1985;;82:6830-6834.
5 +
Emini EA, Ellis RW, Miller WJ, et al:  Production and immunological analysis of recombinant hepatitis B vaccine . J Infect 1986;;13( (suppl A) ):3-9.
6 +
Jilg W, Lorbeer B, Schmidt M, et al:  Clinical evaluation of a recombinant hepatitis B vaccine . Lancet 1984;;2:1174-1175.
7 +
Davidson M, Krugman S:  Immunogenicity of recombinant yeast hepatitis B vaccine . Lancet 1985;;1:108-109.
8 +
Papaevangelou G, Dandolos E, Roumeliotou-Karayannis A, et al:  Immunogenicity of recombinant hepatitis B vaccine . Lancet 1985;;1:455-456.
9 +
Brown SE, Stanley C, Howard CR, et al:  Antibody responses to recombinant and plasma-derived hepatitis B vaccines . Br Med J 1986;;292:159-161.
10 +
Hollinger FB, Troisi CL, Pepe PE:  Anti-HBs responses to vaccination with a human hepatitis B vaccine made by recombinant DNA technology in yeast . J Infect Dis 1986;;153:156-159.
11 +
Alter MJ, Favero MS, Maynard JE:  Impact of infection control strategies on the incidence of dialysis-associated hepatitis in the United States . J Infect Dis 1986;;153:1149-1151.
12 +
Stevens CE, Alter HJ, Taylor PE, et al:  Hepatitis B vaccine in patients receiving hemodialysis: Immunogenicity and efficacy . N Engl J Med 1984;; 311:496-501.
13 +
Stevens CE, Taylor PE, Zang EA, et al:  Human T-cell lymphotropic virus type III infection in a cohort of homosexual men in New York City . JAMA 1986;;255:2167-2172.
14 +
 Recommendations for protection against viral hepatitis . MMWR 1985;;34:313-335.
15 +
Hollinger FB, Adam E, Heiberg D, et al:  Response to hepatitis B vaccine in a young adult population , in Szmuness W, Alter HJ, Maynard JE (eds): Viral Hepatitis: 1981 International Symposium . Philadelphia, The Franklin Institute Press, 1982;, pp 451-466.
16 +
Stevens CE, Toy PT, Tong MJ, et al:  Perinatal hepatitis B virus transmission in the United States: Prevention by passive-active immunization . JAMA 1985;;253:1740-1745.
17 +
Beasley RP, Hwang L-Y, Lee GC-Y, et al:  Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine . Lancet 1983;;2:1099-1102.
18 +
Snedecor GW, Cochran WG: Statistical Methods . Ames, Iowa State University Press, 1971;.
19 +
Schweitzer IL, Wing A, McPeak C, et al:  Hepatitis and hepatitis-associated antigen in 56 mother-infant pairs . JAMA 1972;;220:1092-1095.
20 +
Okada K, Yamada T, Miyakawa Y, et al:  Hepatitis B surface antigen in the serum of infants after delivery from asymptomatic carrier mothers . J Pediatr 1975;;87:360-363.
21 +
Stevens CE, Beasley RP, Tsui J, et al:  Vertical transmission of hepatitis B antigen in Taiwan . N Engl J Med 1975;;292:771-774.
22 +
Lee AKY, Ip HMH, Wong VCW:  Mechanisms of maternal-fetal transmission of hepatitis B virus . J Infect Dis 1978;;138:668-671.
23 +
Tong MJ, Thursby M, Rekela J, et al:  Studies on the maternal-infant transmission of the viruses which cause acute hepatitis . Gastroenterology 1981;;80:999-1004.
24 +
Okada K, Kamiyama I, Inomata M, et al:  e Antigen and anti-e in the serum of asymptomatic carrier mothers as indicators of positive and negative transmission of hepatitis B virus to their infants . N Engl J Med 1976;;294:647-649.
25 +
Beasley RP, Trepo C, Stevens CE, et al:  The e antigen and vertical transmission of hepatitis B surface antigen . Am J Epidemiol 1977;;105:94-98.
26 +
Ohbayashi A:  Genetic and familial aspects of liver cirrhosis and hepatocellular carcinoma , in Okuda K, Peters RL (eds): Hepatocellular Carcinoma . New York, John Wiley & Sons Inc, 1976;, pp 43-51.
27 +
Larouze B, London WT, Saimot G, et al:  Host responses to hepatitis-B infection in patients with primary hepatic carcinoma and their families: A case/control study in Senegal, West Africa . Lancet 1976;;2:534-538.
28 +
Beasley RP, Hwang L-Y, Lin C-C, et al:  Hepatocellular carcinoma and hepatitis B virus: A prospective study of 22 707 men in Taiwan . Lancet 1981;;2:1129-1133.
29 +
Kew MC, Fujita Y, Takahashi H, et al:  Comparison between polyclonal and first and second generation monoclonal radioimmunoassays in the detection of hepatitis B surface antigen in patients with hepatocellular carcinoma . Hepatology 1986;;6: 636-639.
30 +
Beasley RP, Hwang L-Y, Stevens CE, et al:  Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo-controlled trial . Hepatology 1983;;3:135-141.
31 +
Hwang L-Y, Beasley RP, Lee GC-Y, et al:  Prevention of perinatally transmitted hepatitis B virus infection with hepatitis B immune globulin and/or HB vaccine , in Vyas GN, Dienstag JL, Hoofnagle JH (eds): Viral Hepatitis and Liver Disease . Orlando, Fla, Grune & Stratton, 1984;, pp 678-679.
32 +
Wong VCW, Ip HMH, Reesink HW, et al:  Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin: Double-blind randomised placebo-controlled study . Lancet 1984;;1:921-926.
33 +
Lo K-J, Tsai Y-T, Lee S-D, et al:  Immunoprophylaxis of infection with hepatitis B virus in infants born to hepatitis B surface antigen-positive carrier mothers . J Infect Dis 1985;;152:817-822.
34 +
Xu Z-Y, Liu C-B, Francis DP, et al:  Prevention of perinatal acquisition of hepatitis B virus carriage using vaccine: Preliminary report of a randomized, double-blind placebo-controlled and comparative trial . Pediatrics 1985;;76:713-718.
35 +
Neurath AR, Kent SBH:  The pre-S region of hepadnavirus envelope proteins . Ad Virus Res , in press.

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