Table 1.
Interventions in experimental and control groups of included randomised clinical trials assessing effects of hepatitis B vaccines and immunoglobulin for newborn infants of hepatitis B surface antigen positive mothers
| Trial | Experimental group | Control group |
|---|---|---|
| Assateerawatt 199323 | A*: Hepatitis B immunoglobulin 100 IU at birth and recombinant vaccine 20 μg at birth and at 1, 2, and 12 months | B: Recombinant vaccine 20 μg at birth and at 1, 2, and 12 months |
| Beasley 19837,24 | A: Hepatitis B immunoglobulin 1.0 ml (180 IU) at birth and saline at 3 and 6 months. C: Hepatitis B immunoglobulin 0.5 ml (90 IU) diluted in 0.5 ml of immune serum globulin at birth and at 3 and 6 months | B: Saline at birth and 3 and 6 months |
| Beasley 198325 | A: Hepatitis B immunoglobulin 0.5 ml (145 IU) at birth and plasma derived vaccine 20 μg at 4 to 7 days. Followed by boosters 1 and 6 months later | B: Hepatitis B immunoglobulin 0.5 ml (145 IU) and plasma derived vaccine 20 μg at 1 month. Followed by boosters 1 and 6 months later |
| Farmer 198726 | A: Plasma derived vaccine 0.25 ml (5 μg)+hepatitis B immunoglobulin 0.25 ml (25 IU/kg) at birth then plasma derived vaccine+hepatitis B immunoglobulin 0.25 ml (25 IU/kg) at 6 weeks and plasma derived vaccine at 6 months | B: Plasma derived vaccine 0.25 ml (5 μg) at birth and at 6 weeks and 6 months |
| Garcia 199227 | A: 10 μg recombinant vaccine-1 at birth and at 1 and 2 months | B: 10 μg recombinant vaccine-2 at birth and at 1 and 2 months |
| Grosheide 199329 | A: Hepatitis B immunoglobulin 0.5 ml/kg body weight at birth and plasma derived vaccine 10 μg at 2 days and at 1, 2, and 11 months | B: Hepatitis B immunoglobulin 0.5 ml/kg body weight and plasma derived vaccine 10 μg at 3, 4, 5 and 11 months (with diphtheria, pertussis, tetanus, poliomyelitis concomitantly). Hepatitis B immunoglobulin 0.5 ml/kg body weight at 3 months |
| Halliday 199230 | A: Recombinant vaccine 20 μg at birth and at 1 and 6 months. C: Hepatitis B immunoglobulin 260 IU at birth and recombinant vaccine 20 μg at birth and at 1 and 6 months | B: Plasma derived vaccine 20 μg at birth and at 1 and 6 months. D: Hepatitis B immunoglobulin 260 IU at birth and recombinant vaccine 10 μg at birth and at 1 and 6 months |
| Hieu 200231 | A: Hepatitis B immunoglobulin 100 μg and 10 μg recombinant vaccine-1 at birth and Hepavax at 30 and 180 days | B: Hepatitis B immunoglobulin 100 μg and 10 μg recombinant vaccine-2 at birth and Engerix-B at 30 and 180 days |
| Ip 198932,33,54 | A: Plasma derived vaccine 3 μg at birth and at 1, 2, and 6 months. Also, hepatitis B immunoglobulin 200 IU at birth and hepatitis B immunoglobulin 100 IU at monthly intervals during 6 months after birth. C: Plasma derived vaccine 3 μg at birth and at 1, 2, and 6 months | B: Plasma derived vaccine 3 μg at birth and at 1, 2, and 6 months+hepatitis B immunoglobulin 200 IU at birth. D: Placebo |
| Kang 199534 | A: 20 μg recombinant vaccine-1 at birth and at 1 and 6 months | B: 20 μg recombinant vaccine-2 at birth and at 1 and 6 months |
| Khukhlovich 199635 | A: Recombinant vaccine 1 ml at birth and at 1, 2, and 14 months | B: No vaccines |
| Kuru 199536 | A: Plasma derived vaccine 0.5 ml (2.5 μg) and hepatitis B immunoglobulin 200 IU at birth and plasma derived vaccine at 1, 2, and 12 months. C: Recombinant vaccine 0.5 ml (10 μg), hepatitis B immunoglobulin 200 IU at birth and recombinant vaccine at 1, 2, and 12 months | B: Plasma derived vaccine 1 ml (5 μg) and hepatitis B immunoglobulin 200 IU at birth and plasma derived vaccine at 1, 2, and 12 months |
| Lee 199537-39 | A: Hepatitis B immunoglobulin 145 IU and plasma derived vaccine 5 μg at birth and 10 μg recombinant vaccine-1 at 1, 2, and 12 months. C: Hepatitis B immunoglobulin 145 IU and plasma derived vaccine 5 μg at birth and 5 μg recombinant vaccine-2 at 1, 2, and 12 months. E: Hepatitis B immunoglobulin 145 IU at birth and plasma derived vaccine 5 μg at birth and 1 month and 5 μg recombinant vaccine-2 at 2 and 12 months | B: Hepatitis B immunoglobulin 145 IU and plasma derived vaccine 5 μg at birth and plasma derived vaccine 5 μg at 1, 2, and 12 months. D: Hepatitis B immunoglobulin 145 IU and plasma derived vaccine 5 μg at birth and plasma derived vaccine 5 μg at 1, 2, and 12 months. F: Hepatitis B immunoglobulin 145 IU at birth and plasma derived vaccine 5 μg at birth and at 1 month and 10 μg recombinant vaccine-1 at 2 and 12 months |
| Trial | Experimental group | Control group |
| Liu 198740 | A: Plasma derived vaccine 20 μg at birth and at 1, 2, and 6 months. C: Plasma derived vaccine 20 μg at birth and at 1, 2, and 6 months and hepatitis B immunoglobulin at birth | B: Placebo (normal saline) at birth and at 1, 2, and 6 months |
| Lo 198528,41 | A: Hepatitis B immunoglobulin 50 IU at birth and plasma derived vaccine 5 μg at 2, 6, and 10 weeks. C: Plasma derived vaccine 5 μg at 2, 6, and 10 weeks and hepatitis B immunoglobulin 50 IU at birth and at 1 month | B: Plasma derived vaccine 5 μg at 2, 6, and 10 weeks |
| Lolekha 200242 | A: Recombinant vaccine 5 μg at birth and at 1 and 6 months | B: Recombinant vaccine 5 μg at birth and at 1, 2, and 12 months |
| Oon 198643 | A: Plasma derived vaccine 10 μg at birth and at 1 and 2 months. C: Hepatitis B immunoglobulin 100 IU and plasma derived vaccine 10 μg at birth and plasma derived vaccine 10 μg at 1 and 2 months | B: Plasma derived vaccine 5 μg at birth and at 1 and 2 months. D: Hepatitis B immunoglobulin 100 IU and plasma derived vaccine 5 μg at birth and plasma derived vaccine 5 μg at 1 and 2 months |
| Piazza 198544 | A: Plasma derived vaccine 5 μg and hepatitis B immunoglobulin 50 IU at birth and plasma derived vaccine at 1 and 2 months | B: Plasma derived vaccine 5 μg and hepatitis B immunoglobulin 50 IU at birth and plasma derived vaccine at 2 months |
| Pongpipat 198645 | A: 200 IU hepatitis B immunoglobulin-1 at birth and 5 μg plasma derived vaccine-1 at birth and at 1 and 6 months | B: 100 IU hepatitis B immunoglobulin-2 at birth and 10 μg plasma derived vaccine-2 at birth and at 1 and 6 months |
| Pongpipat 198846 | A: Plasma derived vaccine 5 μg and hepatitis B immunoglobulin 100 IU at birth and plasma derived vaccine at 1, 2, and 12 months | B: Plasma derived vaccine 2 μg and hepatitis B immunoglobulin 100 IU at birth and plasma derived vaccine at 1, 2, and 12 months |
| Pongpipat 198947 | A: Recombinant vaccine 5 μg and hepatitis B immunoglobulin 100 IU at birth and recombinant vaccine at 1, 2, and 12 months | B: Plasma derived vaccine 10 μg and hepatitis B immunoglobulin 100 IU at birth and plasma derived vaccine at 1, 2, and 12 months |
| Poovorawan 199748,49 | A: Recombinant vaccine 10 μg and hepatitis B immunoglobulin 100 IU at birth and recombinant vaccine 10 μg at 1 and 6 months. A booster was given at 60 months | B: Recombinant vaccine 10 μg at birth and at 1 and 6 months. A booster was given at 60 months |
| Sehgal 199250,51 | A: Hepatitis B immunoglobulin 0.5 ml and plasma derived vaccine 10 μg at birth and plasma derived vaccine at 4 and 8 weeks | B: Plasma derived vaccine 10 μg at birth and at 4 and 8 weeks |
| Theppisai 198752 | A: Hepatitis B immunoglobulin 200 IU and plasma derived vaccine 10 μg at birth and plasma derived vaccine 10 μg at 1 and 6 months | B: Plasma derived vaccine 10 μg at birth and at 1 and 6 months |
| Theppisai 199053 | A: Hepatitis B immunoglobulin 200 IU at birth and plasma derived vaccine 5 μg at 2 days and 1, 2, and 12 months | B: Hepatitis B immunoglobulin 200 IU at birth and plasma derived vaccine 2 μg at 2 days and 1, 2, and 12 months |
| Xu 199555-57 | A: 16 μg plasma derived vaccine-1 at birth and at 1 and 6 months. C: Hepatitis B immunoglobulin 250 IU at birth and 20 μg plasma derived vaccine-2 at birth and at 1 and 6 months | B: 20 μg plasma derived vaccine-2 at birth and at 1 and 6 months. D: Vaccine diluent plus adjuvant at birth and at 1 and 6 months |
| Yeoh 198658 | A: Mothers positive for hepatitis B surface antigen and positive for hepatitis B e antigen (150 infants): Hepatitis B immunoglobulin 0.5 ml at birth and plasma derived vaccine 10 μg at birth and at 1 and 6 months. C: Mothers positive for hepatitis B surface antigen and negative for hepatitis B e antigen mothers (150 infants). Hepatitis B immunoglobulin 0.5 ml at birth and plasma derived vaccine 10 μg at birth and at 1 and 6 months | B: Mothers positive for hepatitis B surface antigen and positive for hepatitis B e antigen (150 infants): Hepatitis B immunoglobulin 0.5 ml at birth and recombinant vaccine 5 μg at birth and at 1 and 6 months. D: Mothers positive for hepatitis B surface antigen and negative for hepatitis B e antigen (150 infants). Hepatitis B immunoglobulin 0.5 ml at birth and recombinant vaccine 5 μg at birth and at 1 and 6 months |
| Zhu 198760 | A: 16 μg vaccine given at birth, 1 and 6 months | B: Buffer of vaccine given at birth, 1 and 6 months |
| Zhu 199459 | A: Recombinant vaccine 20 μg at birth and at 1 and 6 months | B: Plasma derived vaccine 20 μg at birth and at 1 and 6 months |
*
A-F depicts the different intervention arms used to identify comparisons in trials with more than two interventions shown in figures 2-5.