Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age

Pediatric Infectious Disease Journal

Volumn 15, Issue 7, 1996, Pages 590-596

  Greenberg, David P ^a   Vadheim, Constance M ^a   Wong, Victor K ^b,c,d   Marcy, S Michael ^b,c,d   Partridge, Susan ^a   Greene, Tracy ^e   Chiu, Chung Yin ^a   Margolis, Harold S ^e   Ward, Joel I ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b KAISER PERMANENTE   (United States)

^c Imperial Medical Offices   (United States)

^d Panorama City Medical Offices   (United States)

^e CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

antibody response; Hepatitis B vaccine; immunization; infants; vaccine safety

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B VACCINE; ORAL POLIOMYELITIS VACCINE; RECOMBINANT HEPATITIS B VACCINE;

ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; DRUG SAFETY; ENZYME IMMUNOASSAY; FEMALE; HEPATITIS B; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFANT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL;

CONSUMER PRODUCT SAFETY; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION SCHEDULE; INFANT; MALE; VACCINES, SYNTHETIC;

EID: 0029931726     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006454-199607000-00006     Document Type: Article

References (42)

1. Centers for Disease Control. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40:1-25.
2. American Academy of Pediatrics, Committee on Infectious Diseases. Universal hepatitis B immunization. Pediatrics 1992;89:795-800.
3. Centers for Disease Control. Protection against viral hepatitis: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1990;39:1-26.
4. Alter MJ, Hadler SC, Margolis HS, et al. The changing epidemiology of hepatitis B in the United States: need for alternative vaccination strategies. JAMA 1990;263:1218-22.
5. André FE. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 1989;87(Suppl 3A): 14-20S.
6. Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Comparison of a recomhinant DNA hepatitis B vaccine alone or in combination with hepatitis B immune globulin for the prevention of perinatal acquisition of hepatitis B carriage. Vaccine 1990;8(Suppl):S56-9.
7. Panda SK, Ramesh R, Rao KVS, Gupta A, Zuckerman AJ, Nayak NC. Comparative evaluation of the immunogenicity of yeast-derived (recombinant) and plasma-derived hepatitis B vaccine in infants. J Med Virol 1991;35:297-301.
8. Tsega E, Tafesse B, Horton J, et al. Immunogenicity, reactogenicity and comparison of two doses of recombinant DNA yeast-derived hepatitis B vaccine in Ethiopian children. Trop Geogr Med 1991;43:220-7.
9. West DJ. Clinical experience with hepatitis B vaccines. Am J Infect Control 1989;17:172-80.
10. Goh KT, Tan KL, Kong KH, Oon CJ, Chan SH. Comparison of the immune response of four different dosages of a yeast-recombinant hepatitis B vaccine in Singapore children: a four-year follow-up study. Bull WHO 1992;70:233-9.
11. Assateerawatt A, Tanphaichitr VS, Suvatte V, In-ngarm L. Immunogenicity and protective efficacy of low dose recombinant DNA hepatitis B vaccine in normal and high-risk neonates. Asian Pacific J Allerg Immunol 1991;9:89-93.
12. Milne A, Moyes CD, Allwood GK, Pearce NE, Krugman S. Antibody responses to recombinant, yeast-derived hepatitis B vaccine in teenage New Zealand children. NZ Med J 1988; 101:67-9.
13. Seto D, Diwan A, Hesley T, Calandra G, Miller W. Hepatitis B vaccine alternative vaccination schedules in healthy babies of non-carrier (HBsAg-) mothers. Pediatr Res 1992;31:179A.
14. American Academy of Pediatrics, Committee on Infectious Diseases. Recommended childhood immunization schedule. Pediatrics 1996;97:143:145-6.
15. Vadheim CM, Greenberg DP, Partridge S, Jing J, Ward JI, Kaiser-UCLA Vaccine Study Group. Effectiveness and safety of an Haemophilus Influenzas type b conjugate vaccine (PRP-T) in young infants. Pediatrics 1993;92:272-9.
16. Greenberg DP, Vadheim CM, Partridge S, et al. Immunogenicity of Haemophilus influenzas type b tetanus toxoid conjugate vaccine (PRP-T) in young infants. J Infect Dis 1994; 170:76-81.
17. Dixon WJ, Brown MB, Engelman L, Jennrich RI, eds. BMDP statistical software. Berkeley, CA: University of California Press, 1990.
18. 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;257:2612-6.
19. Cody CL, Baraff LJ, Cherry JD, Marcy SM, Mandark CR. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatrics 1981;68:650-60.
20. Barkin RM, Pichichero ME. Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products. Pediatrics 1979;63:256-60.
21. Long SS, Deforest A, Pennridge Pediatric Associates, Smith DG, Lazaro C, Wassilak SGF. Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy. Pediatrics 1990;85:294-302.
22. Baraff LJ, Cody CL, Cherry JD. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions, and dose. Pedatrics 1984;73:31-6.
23. Verschoor PL, Wilschut JT, de Jonge GA, Kostense PJ. Frequent symptoms after DTPP vaccinations. Arch Dis Child 1991;66:1408-12.
24. Franks AL, Berg CJ, Kane MA, et al. Hepatitis B infection among children born in the United States to southeast Asian refugees. N Engl J Med 1989;321:1301-5.
25. Hurie MB, Mast EE, Davis JP. Horizontal transmission of hepatitis B virus infection to United States-born children of Hmong refugees. Pediatrics 1992;89:269-73.
26. Jilg W, Schmidt M, Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J Infect Dis 1989;160:766-9.
27. Hadler SC, Monzon MA, Lugo DR, Perez M. Effect of timing of hepatitis B vaccine doses on response to vaccine in Yucpa Indians. Vaccine 1989;7:106-10.
28. Goldfarb J, Baley J, Medendorp SV, et al. Comparative study of the immunogenicity and safety of two dosing schedules of Engerix-B hepatitis B vaccine in neonates. Pediatr Infect Dis J 1994;13:18-22.
29. West DJ, Calandra GB, Hesley TM, Ioli V, Miller WJ. Control of hepatitis B through routine immunization of infants: the need for flexible schedules and new combination vaccine formulations. Vaccine 1993;11(Suppl 1):S21-7.
30. 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;303:833-41.
31. Francis DP, Hadler SC, Thompson SE, et al. Prevention of hepatitis B with vaccine: report from the Centers for Disease Control multi-center efficacy trial among homosexual men. Ann Intern Med 1982;97:362-6.
32. Wainwright RB, McMahon BJ, Bulkow LR, Parkinson AJ, Harpster AP. Protection provided by hepatitis B vaccine in a Yupik Eskimo population. Arch Intern Med 1991;151: 1634-6.
33. 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;315:209-14.
34. Lo KJ, Lee SD, Tsai YT, et al. Long-term immunogenicity and efficacy of hepatitis B vaccine in infants born to HBeAg-positive HBsAg-carrier mothers. Hepatology 1988;8:1647-50.
35. Coursaget P, Yvonnet B, Chotard J, et al. Seven year study of hepatitis B vaccine efficacy in infants from an endemic area (Senegal). Lancet 1986;2:1143-5.
36. Lieming D, Mintai Z, Yinfu W, Shaochon Z, Weiqin K, Smego RA. A 9-year follow-up study of the immunogenicity and long-term efficacy of plasma-derived hepatitis B vaccine in high-risk Chinese neonates. Clin Infect Dis 1993;17:475-9.
37. Xu ZY, Duan SC, Margolis HS, et al. Long-term efficacy of active postexposure immunization of infants for prevention of hepatitis B virus infection. J Infect Dis 1995;171:54-60.
38. Hammond GW, Parker J, Mimms L, Tate R, Sekla L, Minuk G. Comparison of immunogenicity of two yeast-derived recombinant hepatitis B vaccines. Vaccine 1991;9:97-100.
39. André FE. Two superb vaccines against hepatitis B in Mexican standoff. JAMA 1988;259:2402-3.
40. Treadwell TL, Keeffe EB, Lake J, et al. Immunogenicity of two recombinant hepatitis B vaccines in older individuals. Am J Med 1993;95:584-8.
41. Bergamini F, Zanetti A. Immunogenicity of yeast-derived hepatitis B vaccines in young adults. Postgrad Med J 1987 63(Suppl 2):1:37-8.
42. Crovari P, Cuneo-Crovari P, Icardi GC, Bonanni P, Coppola RC. Immunization of young adults with two yeast derived hepatitis B vaccines. J Med Virol 1987;21:99A-100A.