Comparative study of the immunogenicity and safety of two dosing schedules of Engerix-B hepatitis B vaccine in neonates

Goldfarb, Johanna; Baley, Jill E.; Medendorp, Sharon V.; Seto, Dexter S. Y.; Garcı́a, Hilda; Toy, Pearl; Watson, Barbara; Gooch, Manford W.; Krause, David S.

doi:10.1097/00006454-199401000-00005

Cited by 43 publications

(17 citation statements)

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“…Another vaccine, Recombivax (Merck), when given at a dose of 2.5 g on the same schedule, showed a 95% seroprotection rate (10). The seroprotection rates in our study were comparable to those results (4,5,6,7,10) for both the test vaccine and the comparator vaccine.…”

Section: Discussionsupporting

confidence: 80%

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Comparison of Two Hepatitis B Vaccines (GeneVac-B and Engerix-B) in Healthy Infants in India

Shivananda

Somani

Srikanth

et al. 2006

Clin Vaccine Immunol

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Hepatitis B is a major problem in many parts of the world. The WHO has recommended the inclusion of hepatitis B vaccines in routine immunization schedules. We wanted to compare two recombinant hepatitis B vaccines in an infant population for immunogenicity and reactogenicity when given at 6, 10, and 14 weeks of age. One hundred seventy-three infants meeting eligibility criteria were given either GeneVac-B (Serum Institute of India Ltd.) or Engerix-B (GlaxoSmithKline Beecham) in a random fashion. Three 0.5-ml (10-g) doses of the vaccines were given at 6, 10, and 14 weeks of age along with diphtheria-pertussis (whole cell)-tetanus (DTPw) vaccine. Blood samples were collected at baseline and 1 month after administration of the third dose of the vaccines to measure anti-HBs antibody levels. Seroconversion was defined as a titer of more than 1 ؋ 10 ؊3 IU/ml, while seroprotection was defined as a titer of more than 10 ؋ 10 ؊3 IU/ml. Of the GeneVac-B recipients, 98% seroconverted versus 99% of the Engerix-B group. The anti-HBs geometric mean titer was slightly greater for GeneVac-B (229 ؋ 10 ؊3 IU/ml) than for Engerix-B (167 ؋ 10 ؊3 IU/ml), but the difference was not significant. The seroprotection rates were similar for both vaccines (96% and 95%, respectively). The most common systemic reaction events were mild to moderate fever, excessive crying, local swelling, rash, and irritability, and the local reactions were redness, induration, and edema, which most probably were caused by the simultaneously administered DTPw vaccine. All events were transient and resolved without sequelae. Reactogenicity was similar for the two vaccines. The present study shows that GeneVac-B is as immunogenic and as well tolerated as Engerix-B when administered with DTPw vaccine at 6, 10, and 14 weeks of age.Hepatitis B is one of the world's major health problems (9). By recent estimates, more than 2 billion people are infected with hepatitis B virus (HBV) globally. This includes 350 million chronic carriers of the virus. The infection is supposed to be causally related to 1 to 2 million deaths per year worldwide (11).In India, too, hepatitis B is a major public health problem. India comes under the intermediate zone (2 to 7%) of HBV prevalence, the carrier rate being approximately 5%. The HBV carrier load is around 38 to 43 million (12).The WHO Assembly endorsed the recommendation of its Global Advisory Group that all countries should implement a hepatitis B immunization program (15). According to the WHO report of March 1994, 72 countries have adopted hepatitis B vaccine in their universal program of immunization (12). However, HBV vaccine has not been included in the national immunization program in India, and cost is one of the limiting factors. The page may be turning, however, because recombinant HBV vaccines are now manufactured locally and the price of the vaccine is much less than that of imported vaccine(s).A recombinant hepatitis B vaccine (GeneVac-B) is manufactured by the Serum Institute of India Ltd., Pune, India. The vaccine ...

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Section: Discussionsupporting

confidence: 80%

“…The GMTs we achieved with our 6-, 10-, and 14-week schedule were somewhat lower for both vaccines than those achieved with a 0-, 1-, and 6-month or a 2-, 4-, and 6-month schedule (4)(5)(6)(7). This could be expected since the antibody levels are greater with a longer interval between the last two doses.…”

Section: Discussionmentioning

confidence: 60%

Comparison of Two Hepatitis B Vaccines (GeneVac-B and Engerix-B) in Healthy Infants in India

Shivananda

Somani

Srikanth

et al. 2006

Clin Vaccine Immunol

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“…As many as 80-95% of infants born to mothers positive for both HBsAg and HBeAg (hepatitis B e antigen) become chronic carriers with a greatly increased risk of developing cirrhosis and hepatocellular carcinoma (41,(60)(61)(62)(63). Even with active vaccination and passive immunization using anti-HBs IgG, 5-10% of such infants (16% in one study) still become chronically infected (40,41).…”

Section: Discussionmentioning

confidence: 99%

CpG DNA can induce strong Th1 humoral and cell-mediated immune responses against hepatitis B surface antigen in young mice

Millan

Weeratna

Krieg

et al. 1998

Proc. Natl. Acad. Sci. U.S.A.

307

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Successful neonatal immunization of humans has proven difficult. We have evaluated CpG-containing oligonucleotides as an adjuvant for immunization of young mice (1-14 days old) against hepatitis B virus surface antigen. The protein-alum-CpG formulation, like the DNA vaccine, produced seroconversion of the majority of mice immunized at 3 or 7 days of age, compared with 0-10% with the proteinalum or protein-CpG formulations. All animals, from neonates to adults, immunized with the protein-alum vaccine exhibited strong T helper (Th)2-like responses [predominantly IgG1, weak or absent cytotoxic T lymphocytes (CTL)]. Th2-type responses also were induced in young mice with protein-CpG (in 1-, 3-, and 7-day-old mice) and protein-alumCpG (in 1-and 3-day-old mice) but immunization carried out at older ages gave mixed Th1͞Th2 (Th0) responses. DNA vaccines gave Th0-like responses when administered at 1 and 7 days of age and Th1-like (predominantly IgG2a and CTL) responses with 14-day-old or adult mice. Surprisingly, the protein-alum-CpG formulation was better than the DNA vaccine for percentage of seroconversion, speed of appearance, and peak titer of the antibody response, as well as prevalence and strength of CTL. These findings may have important implications for immunization of human infants.

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“…Engerix-B induced a seroconversion of 98.5% when administered at 2, 4 and 6 months of age (Goldfarb et al, 1996). When administered to infants of 0, 1, and 6 months of age, Engerix-B showed 96% seroprotection (Goldfarb et al, 1994). Recombivax of Merck protected 99% of infants when administered at 2, 4, and 6 months of age (Greenberg et al, 1996).…”

Section: Discussionmentioning

confidence: 99%

“…When compared with different immunization schedules (0, 1 and 6 months 13 and 2, 4 and 6 months) (Goldfarb et al, 1994) factors associated with non-response to hepatitis B vaccine is supposed to be male gender (Kubba et al, 2003). However, this was not evident in our study.…”

Section: Discussionmentioning

confidence: 99%

Assessment of immune response and safety of two recombinant hepatitis B vaccines in healthy infants in India

Ashok¹,

G²,

Rajendran³

et al. 2011

Afr. J. Biotechnol.

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Hepatitis B infection and its sequel continue to be a worldwide health problem, especially in the developing countries. The pool of chronic carriers of hepatitis B virus is built up in childhood and is then maintained in older children and adults. Therefore, it is important to give protection during infancy. Effective vaccines to prevent hepatitis B infection are available. This study was undertaken to evaluate the immune response and reactogenicity of two recombinant hepatitis B vaccines available in Indian market, in normal healthy infants. Infants of 6-8 weeks of age were screened for eligibility criteria. All the eligible subjects had negative baseline serum HBsAg and anti-HBs. The subjects received three doses of 10 µg of Gene Vac-B or Engerix-B at 6, 10 and 14 weeks of age. GeneVac-B is an indigenously manufactured vaccine, while Engerix-B is an imported vaccine. The vaccinees were assessed for immune response and safety parameters. The anti-HBs antibody titer was obtained 1 month after 3 rd dose of vaccine and was considered seroconverted if more than 1 mIU/ml, and seroprotective if more than 10 mIU/ml. Total of 126 subjects were considered for analysis. One month after 3 rd dose, seroconversion was 100% for both the vaccines and seroprotection was 94.36% for Gene Vac-B, and 92.72% for Engerix B. The GMT of anti-HBs antibodies were 149.47 mIU/ml for Gene Vac-B and 153.28 mIU/ml for Engerix B. Four cases of incessant cry were observed during the study period. The indigenous vaccine, Gene Vac-B and the imported vaccine, Engerix-B showed high immunogenicity and safety profile in Indian infant population. Both vaccines were comparable.

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Comparative study of the immunogenicity and safety of two dosing schedules of Engerix-B hepatitis B vaccine in neonates

Cited by 43 publications

References 0 publications

Comparison of Two Hepatitis B Vaccines (GeneVac-B and Engerix-B) in Healthy Infants in India

Comparison of Two Hepatitis B Vaccines (GeneVac-B and Engerix-B) in Healthy Infants in India

CpG DNA can induce strong Th1 humoral and cell-mediated immune responses against hepatitis B surface antigen in young mice

Assessment of immune response and safety of two recombinant hepatitis B vaccines in healthy infants in India

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