Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine.
A chromatographically purified Vero cell rabies vaccine, Indirab manufactured by Bharat Biotech International Limited, Hyderabad, India was subjected to safety and immunogenicity studies by both intramuscular and intradermal routes of administration in parallel with a reference vaccine, Verorab. A Pre-exposure study was undertaken in 239 subjects by intramuscular (IM) route (Study I), Post-exposure study in 188 patients by intramuscular route (Study II) and Simulated post-exposure study in 134 subjects by intradermal (ID) route (Study III). All subjects in these studies were administered with either the test or the reference vaccine as per WHO approved intramuscular and intradermal regimens. The blood samples were collected on days 0, 14 and 35 in case of Study 1, and days 0, 14, 28 and 90 in case of studies II and III. In all studies both vaccine groups had adequate antibody titers (>0.5 IU/mL) on all days tested post-vaccination and there was no significant difference in the titers observed (p>0.05). Some side effects like pain, induration, itching and fever were noted in both vaccine groups in all studies. Both vaccines were well tolerated. Hence it can be concluded that Indirab is as safe and immunogenic as Verorab when administered by both intramuscular and intradermal routes.
Sampath
Gadey
G
Institute of Preventive Medicine, Hyderabad, India.
Madhusudana
Shampur Narayan
SN
Sudarshan
Mysore Kalappa
MK
Ashwathnarayana
Doddabele Hanumanthaiah
DH
Mahendra
Bangalore Jayakrishna
BJ
Ullas
Thankappan P
TP
Mohan
Krishna
K
Madhusudhan
Santhosh Kumar
SK
Ravish
Haradanahalli Shankariah
HS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002522:Chlorocebus aethiops; D002845:Chromatography; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D011818:Rabies / Q000276:immunology / Q000517:prevention & control; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014709:Vero Cells; D055815:Young Adult
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines