0
May 15, 1987, Vol 257, No. 19 >
ARTICLE | May 15, 1987

Hepatitis B Vaccines—to Switch or Not to Switch FREE

F. Blaine Hollinger, MD
JAMA. 1987;257(19):2634-2636. doi:10.1001/jama.1987.03390190112033
Text Size: A A A
Published online
Article
References

With the recent licensure of a hepatitis B vaccine prepared in yeast by recombinant DNA technology (Recombivax-HB), a new era in vaccine development has emerged. The vaccine it is designed to compete with—Heptavax-B—is also a uniquely formulated product in that it is prepared from the plasma of humans chronically infected with hepatitis B. Several placebo-controlled, randomized, double-blind trials have clearly documented that the plasma-derived vaccine is highly effective in preventing hepatitis B in high-risk groups.1-3

Shortly after the licensure of Heptavax-B in 1981 and its general availability in July 1982, the discovery of the acquired immunodeficiency syndrome (AIDS) among male homosexuals threatened the success of this product, since some of the hepatitis B surface antigen (HBsAg)-positive plasma donors were members of this high-risk group. Intensive epidemiologic, virological, and serological evaluations were launched, which eventually found no evidence for the transmission of AIDS to recipients of the plasma-derived HBsAg vaccine.

REFERENCES

1 +
Szmuness W, Stevens CE, Harley EJ, et al:  Hepatitis B vaccine: Demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States . N Engl J Med 1980;;303:833-841.
2 +
Francis DP, Hadler SC, Thompson SE, et al:  The prevention of hepatitis B with vaccine: Report of the Centers for Disease Control multi-center efficacy trial among homosexual men . Ann Intern Med 1982;;97:362-366.
3 +
Szmuness W, Stevens CE, Harley EJ, et al:  Hepatitis B vaccine in medical staff of hemodialysis units: Efficacy and subtype cross-protection . N Engl J Med 1982;;307:1481-1486.
4 +
Stevens CE, Taylor PE, Rubinstein P, et al:  Safety of the hepatitis B vaccine . N Engl J Med 1985;;312:375-376.
5 +
Poiesz B, Tomar R, Lehr B, et al:  Hepatitis B vaccine: Evidence confirming lack of AIDS transmission . MMWR 1984;;33:685-687.
6 +
Francis DP, Feorino PM, McDougal S, et al:  The safety of the hepatitis B vaccine: Inactivation of the AIDS virus during routine vaccine manufacture . JAMA 1986;;256:869-872.
7 +
Hollinger FB, Troisi CL, Pepe PE:  Anti-HBs response to vaccination with a human hepatitis B vaccine made by recombinant DNA technology in yeast . J Infect Dis 1986;;153:156-159.
8 +
Zajac BA, West DJ, McAleer WJ, et al:  Overview of clinical studies with hepatitis B vaccine made by recombinant DNA . J Infect 1986;;13( (A) ):39-45.
9 +
Stevens CE, Taylor PE, Tong MJ, et al:  Yeast-recombinant hepatitis B vaccine: Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission . JAMA 1987;;257:2612-2616.
10 +
Milich DR, Thornton GB, Neurath AR, et al:  Enhanced immunogenicity of the pre-S region of hepatitis B surface antigen . Science 1985;;228:1195-1198.
11 +
Hellstrom U, Sylvan S, Kuhns M, et al:  Absence of pre-S2 antibodies in natural hepatitis B virus infection . Lancet 1986;;2:889-893.
12 +
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 states: Final report of a randomized double-blind, placebo-controlled trial . Hepatology 1983;;3:135-141.
13 +
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 randomized placebo-controlled study . Lancet 1984;;1:921-926.
14 +
Hollinger FB, Adam E, Zahradnik J, et al: Hepatitis B Vaccine , DAB-VDP-188. National Institutes of Health, National Institute for Allergic Infectious Diseases, Contracts Management Branch, Bethesda, Md, 1983;.
15 +
Zahradnik J, Heiberg D, Hollinger FB:  Hepatitis B vaccine, immune responses and reactions in children from families with an HBsAg carrier . Vaccine 1985;;3:407-413.
16 +
Troisi CL, Heiberg DA, Hollinger FB:  Normal immune response to hepatitis B vaccine in patients with Down's syndrome: A basis for immunization guidelines . JAMA 1985;;254:3196-3199.
17 +
Weber DJ, Rutala WA, Samsa GP, et al:  Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine . JAMA 1985;;254:3187-3189.
18 +
McLean AA, Guess HA, Scolnick EM, et al:  Suboptimal response to hepatitis B vaccine given by injection into the buttock . MMWR 1985;; 34:105-108, 113.
19 +
Kohler H, Arnold W, Renschin G, et al:  Active hepatitis B vaccination of dialysis patients and medical staff . Kidney Int 1984;;25:124-128.
20 +
Szmuness W, Stevens CE, Harley EJ, et al:  The immune response of healthy adults to a reduced dose of hepatitis B vaccine . J Med Virol 1981;;8:123-129.
21 +
Torre D, Maggiolo F, Broggini M, et al:  Age-related response to hepatitis B vaccine in the mentally retarded . Lancet 1984;;2:866.
22 +
Denis F, Mounier M, Hessel L, et al:  Hepatitis-B vaccination in the elderly . J Infect Dis 1984;;149:1019.
23 +
Stevens CE, Alter HJ, Taylor PE, et al:  Hepatitis B vaccine in patients receiving hemodialysis . N Engl J Med 1984;;311:496-501.
24 +
Hadler SC, Francis DP, Maynard JE, et al:  Long-term immunogenicity and efficacy of hepatitis B vaccine in homosexual men . N Engl J Med 1986;;315:209-214.
25 +
Stevens CE, Taylor PE, Tong MJ, et al:  Hepatitis B vaccine: An overview , in Vyas GN, Dienstag JL, Hoofnagle JH (eds): Viral Hepatitis and Liver Disease . Orlando, Fla, Grune & Stratton, 1984;, pp 275-291.
26 +
Dandolos E, Roumeliotou-Karayannis A, Richardson SC, et al:  Safety and immunogenicity of a recombinant hepatitis B vaccine . J Med Virol 1985;;17:57-62.
27 +
Jilg W, Schmidt M, Zoulek G, et al:  Clinical evaluation of a recombinant hepatitis B vaccine . Lancet 1984;;2:1174-1175.
28 +
Purcell RH, Gerin JL:  Prospects for second and third generation hepatitis B vaccines . Hepatology 1985;;5:159-163.
29 +
McAleer WJ, Buynak EB, Maigetter RZ, et al:  Human hepatitis B vaccine from recombinant yeast . Nature 1984;;307:178-180.

Figures

Tables

Interactive Graphics

Video

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 +
Szmuness W, Stevens CE, Harley EJ, et al:  Hepatitis B vaccine: Demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States . N Engl J Med 1980;;303:833-841.
2 +
Francis DP, Hadler SC, Thompson SE, et al:  The prevention of hepatitis B with vaccine: Report of the Centers for Disease Control multi-center efficacy trial among homosexual men . Ann Intern Med 1982;;97:362-366.
3 +
Szmuness W, Stevens CE, Harley EJ, et al:  Hepatitis B vaccine in medical staff of hemodialysis units: Efficacy and subtype cross-protection . N Engl J Med 1982;;307:1481-1486.
4 +
Stevens CE, Taylor PE, Rubinstein P, et al:  Safety of the hepatitis B vaccine . N Engl J Med 1985;;312:375-376.
5 +
Poiesz B, Tomar R, Lehr B, et al:  Hepatitis B vaccine: Evidence confirming lack of AIDS transmission . MMWR 1984;;33:685-687.
6 +
Francis DP, Feorino PM, McDougal S, et al:  The safety of the hepatitis B vaccine: Inactivation of the AIDS virus during routine vaccine manufacture . JAMA 1986;;256:869-872.
7 +
Hollinger FB, Troisi CL, Pepe PE:  Anti-HBs response to vaccination with a human hepatitis B vaccine made by recombinant DNA technology in yeast . J Infect Dis 1986;;153:156-159.
8 +
Zajac BA, West DJ, McAleer WJ, et al:  Overview of clinical studies with hepatitis B vaccine made by recombinant DNA . J Infect 1986;;13( (A) ):39-45.
9 +
Stevens CE, Taylor PE, Tong MJ, et al:  Yeast-recombinant hepatitis B vaccine: Efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission . JAMA 1987;;257:2612-2616.
10 +
Milich DR, Thornton GB, Neurath AR, et al:  Enhanced immunogenicity of the pre-S region of hepatitis B surface antigen . Science 1985;;228:1195-1198.
11 +
Hellstrom U, Sylvan S, Kuhns M, et al:  Absence of pre-S2 antibodies in natural hepatitis B virus infection . Lancet 1986;;2:889-893.
12 +
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 states: Final report of a randomized double-blind, placebo-controlled trial . Hepatology 1983;;3:135-141.
13 +
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 randomized placebo-controlled study . Lancet 1984;;1:921-926.
14 +
Hollinger FB, Adam E, Zahradnik J, et al: Hepatitis B Vaccine , DAB-VDP-188. National Institutes of Health, National Institute for Allergic Infectious Diseases, Contracts Management Branch, Bethesda, Md, 1983;.
15 +
Zahradnik J, Heiberg D, Hollinger FB:  Hepatitis B vaccine, immune responses and reactions in children from families with an HBsAg carrier . Vaccine 1985;;3:407-413.
16 +
Troisi CL, Heiberg DA, Hollinger FB:  Normal immune response to hepatitis B vaccine in patients with Down's syndrome: A basis for immunization guidelines . JAMA 1985;;254:3196-3199.
17 +
Weber DJ, Rutala WA, Samsa GP, et al:  Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine . JAMA 1985;;254:3187-3189.
18 +
McLean AA, Guess HA, Scolnick EM, et al:  Suboptimal response to hepatitis B vaccine given by injection into the buttock . MMWR 1985;; 34:105-108, 113.
19 +
Kohler H, Arnold W, Renschin G, et al:  Active hepatitis B vaccination of dialysis patients and medical staff . Kidney Int 1984;;25:124-128.
20 +
Szmuness W, Stevens CE, Harley EJ, et al:  The immune response of healthy adults to a reduced dose of hepatitis B vaccine . J Med Virol 1981;;8:123-129.
21 +
Torre D, Maggiolo F, Broggini M, et al:  Age-related response to hepatitis B vaccine in the mentally retarded . Lancet 1984;;2:866.
22 +
Denis F, Mounier M, Hessel L, et al:  Hepatitis-B vaccination in the elderly . J Infect Dis 1984;;149:1019.
23 +
Stevens CE, Alter HJ, Taylor PE, et al:  Hepatitis B vaccine in patients receiving hemodialysis . N Engl J Med 1984;;311:496-501.
24 +
Hadler SC, Francis DP, Maynard JE, et al:  Long-term immunogenicity and efficacy of hepatitis B vaccine in homosexual men . N Engl J Med 1986;;315:209-214.
25 +
Stevens CE, Taylor PE, Tong MJ, et al:  Hepatitis B vaccine: An overview , in Vyas GN, Dienstag JL, Hoofnagle JH (eds): Viral Hepatitis and Liver Disease . Orlando, Fla, Grune & Stratton, 1984;, pp 275-291.
26 +
Dandolos E, Roumeliotou-Karayannis A, Richardson SC, et al:  Safety and immunogenicity of a recombinant hepatitis B vaccine . J Med Virol 1985;;17:57-62.
27 +
Jilg W, Schmidt M, Zoulek G, et al:  Clinical evaluation of a recombinant hepatitis B vaccine . Lancet 1984;;2:1174-1175.
28 +
Purcell RH, Gerin JL:  Prospects for second and third generation hepatitis B vaccines . Hepatology 1985;;5:159-163.
29 +
McAleer WJ, Buynak EB, Maigetter RZ, et al:  Human hepatitis B vaccine from recombinant yeast . Nature 1984;;307:178-180.

Letters

Submit a Letter
CME Course for:


You need to register in order to view this quiz.


To understand the clinical management of acute heart failure syndromes.
Accreditation Information The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
To view and print your certificate and access a summary of your CME courses go to My CME.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s “Cited By” API will populate this tab (http://www.crossref.org/citedby.html).
Compression-Only CPR: Pushing the Science Forward
Cone
AAM 2010;304:1493-1495.
All you need to read in the other general journals
BMJ 2010;341:c5893-c1494.
Submit a Response

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

© 2012 American Medical Association. All Rights Reserved.
Powered bySilverchair Information Systems