Evaluation of a new recombinant DNA hepatitis B vaccine (Shanvac-B).
We assessed the efficacy and safety of Shanvac-B, a new recombinant hepatitis B vaccine developed in India. Eighty-one healthy volunteers (75 women, 6 men; aged 18-40 yr), negative for markers for hepatitis B and HIV, received 20 microg of the vaccine intramuscularly at 0, 1 and 2 months. Forty-three (53%) seroconverted at one month after dose 1; of these, 26% were seroprotected (anti-HBs> 10 mIU/mL). Seroprotection at one month after doses 2 and 3 was 99% and 100%, respectively. Geometric mean titres of anti-HBs in subjects who seroconverted were 11 (range 2-366), 266 (8-7469) and 2246 (102-23680) mIU/mL, respectively. One subject developed urticarial rash after the second dose; there was no other adverse event. We conclude that this vaccine is safe and efficacious, providing significant protection even after two doses.
Abraham
P
P
Department of Gastroenterology, King Edward Memorial Hospital, Mumbai, India.
Mistry
F P
FP
Bapat
M R
MR
Sharma
G
G
Reddy
G R
GR
Prasad
K S
KS
Ramanna
V
V
D000293:Adolescent; D000328:Adult; D000595:Amino Acid Sequence; D001483:Base Sequence; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000235:genetics / Q000648:ultrastructure; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008854:Microscopy, Electron; D008969:Molecular Sequence Data; D011994:Recombinant Proteins / Q000008:administration & dosage; D019444:Vaccines, DNA / Q000008:administration & dosage
D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011994:Recombinant Proteins; C522543:Shanvac B; D019444:Vaccines, DNA