Hepatitis B Immunisation With a Reduced Number of Doses in Newborn Babies and Children

Piazza, Marcello; Villari, Riccardo; Orlando, Raffaele; Macchia, Vincenzo; Vegnente, Angela; Scarcella, A; Cirillo, Cheryl; Isabella, E.; Picciotto, L; Guadagnino, Vincenzo; Isabella, L.; Memoli, A.M.; Borrelli, A.M.; Cascioli, C.; Coppola, Peter R.; Parisi, Gabriella

doi:10.1016/s0140-6736(85)91726-x

Cited by 25 publications

(6 citation statements)

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“…First, a vaccination schedule consisting of two full doses given at birth and at 2 months is less immunogenic than three half doses given at a l-month interval, starting at birth as indicated in the present study. This has also been reported in a previous study (24). Second, since the booster vaccination is considered essential for solid immunity, a change should be considered for the time of the booster vaccination from 14 months in the study to 15 months of age when the measles-mumps-rubella immunization is scheduled as a routine pediatric vaccination in Korea, provided it will not interfere with each other because integration of hepatitis B vaccine into an existing expanded program of immunization will surely increase the follow-up rate and compliance (11,12).…”

Section: Discussionsupporting

confidence: 92%

Hepatitis B vaccination of newborn infants: Clinical study of new vaccine formulation and dose regimen

Lee

Moon

et al. 1987

Hepatology

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To investigate the efficacy in anti-HBsAg response with half the recommended adult dose in a standard vaccination schedule or with a full dose in reduced number of vaccination schedule, 201 healthy newborn infants were randomized to receive either 2.5 micrograms Hevac B vaccine at birth [1, 2 and 14 months in Group I (101)] or 5 micrograms at birth [2 and 14 months in Group II (100)]. Anti-HBsAg responses in the two groups were compared. Passively acquired anti-HBsAg positivity rates at birth were 51.5 and 45.0% in Groups I and II, respectively. Cumulative anti-HBsAg seroconversion rates in Group I were 12.2, 76.6, 82.6 and 86.4% at 2, 4, 14 and 16 months, while the rates in Group II were 2.5, 62.5, 73.7 and 91.0%, showing no significant difference (p greater than 0.05). Significant difference in seroconversion rates at the 2-month follow-up stage between passively acquired anti-HBsAg-negative and -positive groups was observed (11.9 vs. 2.6%). Significant rise in anti-HBsAg titer at 16 months following the booster at 14 months was noted: 36.4 mIU per ml before, 546.4 mIU per ml after in Group I and 25.3 mIU per ml before, 782.6 mIU per ml after in Group II. The booster, 12 months after the primary vaccination series, is therefore considered imperative for maximum effectiveness of hepatitis B active immunization.(ABSTRACT TRUNCATED AT 250 WORDS)

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Section: Discussionsupporting

confidence: 92%

Hepatitis B vaccination of newborn infants: Clinical study of new vaccine formulation and dose regimen

Lee

Moon

et al. 1987

Hepatology

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“…Generation of the allocation sequence was adequately described in six trials 23 26 30 31 43 44. Treatment allocation was adequately concealed in six trials 29 – 32 40 44.…”

Section: Resultsmentioning

confidence: 99%

“…Treatment allocation was adequately concealed in six trials 29 – 32 40 44. Adequate methods of double blinding were reported in three trials 30 32 40.…”

Section: Resultsmentioning

confidence: 99%

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Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis

Lee

Yang

Brok

et al. 2006

BMJ

356

247

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Objective To evaluate the effects of hepatitis B vaccine and immunoglobulin in newborn infants of mothers positive for hepatitis B surface antigen. Design Systematic review and meta-analysis of randomised clinical trials. Data sources Electronic databases and hand searches. Review methods Randomised clinical trials were assessed for methodological quality. Meta-analysis was undertaken on three outcomes: the relative risks of hepatitis B occurrence, antibody levels to hepatitis B surface antigen, and adverse events. Results 29 randomised clinical trials were identified, five of which were considered high quality. Only three trials reported inclusion of mothers negative for hepatitis B e antigen.

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“…At 12 months of age, 45% of infants in Groups A and B, and 90% of infants in Groups C and D remained negative for HBsAg and anti-HBs. These infants were still susceptible to HBV, and a substantial portion of them will become HBsAg carriers after HBV infection [Beasley and Hwang, 19831. Because of the transient protection yielded by HBIG alone and the inadequate efficacy of hepatitis B vaccine alone (Lee, Hwang, Beasley, unpublished observations, 1985), many investigators have started the regimen of HBIG plus hepatitis B vaccine in blocking perinatal HBV transmission [Wong et al, 1984;Maze1 et al, 1984;Tada et al, 1982;Chung et al, 1985;Kanai et al, 1985;Piazza et al, 1985;Lo et al, 19851. With HBeAg-positive mothers, our government has adopted the policy of giving 0.5 ml of HBIG to the newborns as soon as possible after birth, followed by four doses of hepatitis B vaccine: at 1 week, 5 weeks, 9 weeks, and 12 months of age [The Hepatitis Control Committee and the Epidemiology Division of the Department of Health, 19851.…”

Section: Discussionmentioning

confidence: 99%

Reduced doses of hepatitis B immune globulin in the prevention of perinatal transmission of hepatitis B

Ko¹,

Hsieh²,

Yaung³

et al. 1987

Journal of Medical Virology

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From October 1982 to May 1983, newborn infants of 79 hepatitis B surface antigen (HBsAg)-positive women were enrolled in a study of the efficacy of hepatitis B immune globulin (HBIG) in the prophylaxis of perinatal transmission of hepatitis B virus (HBV) infection. HBIG 0.5 ml or 0.25 ml was given to the newborn within 15 minutes of birth and at 3 and 6 months. The mother-infant pairs were followed-up every 3 months for at least 9 months. Similar observations of untreated infants were used for comparison. Among infants of hepatitis B e antigen (HBeAg)-positive carrier mothers, the HBsAg carrier rates at 3 months were similar in the 0.5-ml and 0.25-ml HBIG dose groups. At 12 months the difference--17.7% of 17, 40% of 15--did not reach statistical significance, but the differences between these rates and that of the untreated control-85.7% of 35--did. Among infants of HBeAg-negative carrier mothers, HBV infection rates in both dose groups were similar to those of untreated infants. In the treated groups at 12 months about 45% of infants of HBeAg-positive mothers and 90% of infants of HBeAg-negative mothers were still negative for HBsAg and anti-HBs. Vaccination to induce active antibody is necessary to prevent postnatal infection and chronic carriage of HBV. To reduce the cost of combined passive and active hepatitis B immunoprophylaxis in children born to HBeAg-positive carrier mothers, 0.25 ml of HBIG could be used instead of the usually recommended 0.5 ml.

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Hepatitis B Immunisation With a Reduced Number of Doses in Newborn Babies and Children

Cited by 25 publications

References 0 publications

Hepatitis B vaccination of newborn infants: Clinical study of new vaccine formulation and dose regimen

Hepatitis B vaccination of newborn infants: Clinical study of new vaccine formulation and dose regimen

Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis

Reduced doses of hepatitis B immune globulin in the prevention of perinatal transmission of hepatitis B

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