Safety and immunogenicity of indigenous recombinant hepatitis B vaccine (Shanvac-B) in comparison with commercially available vaccine.

AIM: To assess the clinical safety, reactogenicity and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac-B; Shantha Biotechnics) and to compare it with another commercially available vaccine (Engerix-B, SmithKline Beecham) in healthy adults. METHODS: 120 healthy adults randomLy received 20 micrograms of either Engerix-B (Group A; n = 61) or Shanvac-B (Group B; n = 59) in 0, 1, 2 months schedule. Anti HBs was assessed using commercially available AUSAB kits (Abbott Laboratories) one month after each dose. RESULTS: Protective seroconversion rates after first, second and third dose were 10%, 62.7% and 91.4%, respectively in Group A and 22.4%, 68.9% and 96.4% in Group B, respectively. The geometric mean titer (GMT) after the third dose was significantly high in Group B (419 mIU/mL) than in Group A (140 mIU/mL; p < 0.001). The GMT was significantly higher in women in both the groups. The indigenous vaccine was found to be clinically safe and well tolerated without significant side effects. CONCLUSION: The recombinant hepatitis B vaccine (Shanvac-B) developed in India is safe, well tolerated, and highly immunogenic, with high seroconversion and GMT response.

Hepatitis in falciparum malaria.

BACKGROUND: Hepatocellular jaundice occurring in patients with falciparum malaria has been called as malarial hepatitis. METHODS: We studied 95 consecutive patients admitted with falciparum malaria. Of these 20 had evidence of malarial hepatitis. Their clinical presentation, complications and response to treatment was compared with that of patients without evidence of malarial hepatitis. RESULTS: The clinical presentation of these patients was not different from those without hepatitis. However, the incidence of complications such as renal failure (60% vs 25%; X2 = 8.47, p < 0.01), Adult Respiratory Distress Syndrome (35% vs 3%; X2 = 18.13, p < 0.001) and septicemia (20% vs 6%; X2 = 4.01, p < 0.05) was significantly higher. The mortality also was higher in the group of patients with malarial hepatitis (40% vs 17%; X2 = 4.85, p < 0.05). CONCLUSIONS: We conclude that the presence of hepatitis in patients with falciparum malaria indicates a more severe illness with a higher incidence of complications and a poor prognosis.

Clinical safety and efficacy of first indigenous recombinant hepatitis B vaccine.

A pilot study was conducted to assess the clinical safety and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac B) in 18 healthy adults. 20 microg of vaccine was administered at 0, 1 and 2 months. Protective anti HBs titres developed in 22%, 77% and 100% one month after 1st, 2nd and 3rd dose of vaccination, respectively. The geometric mean titre after the 3rd dose was 1015.29 mIu/ml. The vaccine was well tolerated with minor local and systemic side effects in 28% and 22%, respectively. The indigenously developed recombinant hepatitis B vaccine is safe, well tolerated and highly immunogenic.

Intestinal strongyloidiasis--a rare opportunistic infection.

We describe the features of intestinal strongyloidiasis in six patients; five of them were immunosuppressed (four on corticosteroids, one with chronic renal failure). Vomiting and diarrhea were the predominant symptoms. Duodenal mucosa on endoscopy varied from normal to severe ulceration. Albendazole 400 mg/day for two weeks was effective. This condition should be considered in immunosuppressed individuals with gastrointestinal symptoms, especially since these symptoms may be mistakenly attributed to the underlying disease.

Endoscopic treatment of postoperative biliary leak.

External biliary leak is a rare complication of biliary tract surgery. We report six cases in which postoperative biliary-cutaneous fistulae were treated successfully by endoscopic sphincterotomy and endoprosthesis placement. This procedure is safe, associated with minimum morbidity and appears to be a viable alternative to surgery in the management of biliary leaks.