Clinical trial of the intradermal administration of hepatitis B vaccine produced at the Department of Medical Research, Myanmar.
A total of 280 apparently healthy volunteers were screened for hepatitis B (HB) markers out of which 49 subjects (17.5%) were positive for HB surface antigen (HBsAg) and 82 (29.3%) were positive for antibody to HBsAg (anti-HBs). Three doses of DMR-HB vaccine, 0.15 ml per dose were administered to 95 subjects, who were serologically negative for both HB markers. The vaccination was given by the intradermal route on the flexor surface of the left forearm, at 1 month intervals according to the 0, 1 and 2 months schedule. The subjects were carefully monitored to record any adverse reaction of the vaccine. Blood specimen was collected from each subject, 1 month after the second and third vaccinations, to determine the anti-HBs antibody response to the vaccine. The study results showed that local pain was the only side effect noted and protective antibodies (anti-HBs) were detected in 69 (72.6%) of the vaccinees after the second dose of the vaccine and 89 (93.6%) after the third dose of the vaccine. Thus the intradermal route, which would require approximately one-seventh of the standard dose, would be suitable for use in certain groups such as high risk adults, when the cost of the vaccine is the inhibiting factor for routine or mass vaccination.
Kyi
Khin Pyone
KP
Department of Medical Research (Lower Myanmar), Vaccine Production and Distribution Division, 5 Ziwaka Road, Dagon PO, Yangon 11191, Myanmar.
Oo
Khin May
KM
Htun
Moh Moh
MM
Tun
Win Maw
WM
Aye
Khin Khin
KK
Oo
San San
SS
Lwin
Khin Ohmar
KO
Nyunt
Sandar
S
D000328:Adult; D003365:Costs and Cost Analysis; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000302:isolation & purification; D006801:Humans; D007115:Immunization Schedule; D007271:Injections, Intradermal; D008297:Male; D002052:Myanmar; D010146:Pain / Q000209:etiology
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines