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Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine.
Vaccine. 2010 May 28; 28(24):4086-90.V

Abstract

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.

Authors+Show Affiliations

Institute of Preventive Medicine, Hyderabad, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20403351

Citation

Sampath, Gadey, et al. "Immunogenicity and Safety Study of Indirab: a Vero Cell Based Chromatographically Purified Human Rabies Vaccine." Vaccine, vol. 28, no. 24, 2010, pp. 4086-90.
Sampath G, Madhusudana SN, Sudarshan MK, et al. Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine. Vaccine. 2010;28(24):4086-90.
Sampath, G., Madhusudana, S. N., Sudarshan, M. K., Ashwathnarayana, D. H., Mahendra, B. J., Ullas, T. P., Mohan, K., Madhusudhan, S. K., & Ravish, H. S. (2010). Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine. Vaccine, 28(24), 4086-90. https://doi.org/10.1016/j.vaccine.2010.03.064
Sampath G, et al. Immunogenicity and Safety Study of Indirab: a Vero Cell Based Chromatographically Purified Human Rabies Vaccine. Vaccine. 2010 May 28;28(24):4086-90. PubMed PMID: 20403351.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety study of Indirab: a Vero cell based chromatographically purified human rabies vaccine. AU - Sampath,Gadey, AU - Madhusudana,Shampur Narayan, AU - Sudarshan,Mysore Kalappa, AU - Ashwathnarayana,Doddabele Hanumanthaiah, AU - Mahendra,Bangalore Jayakrishna, AU - Ullas,Thankappan P, AU - Mohan,Krishna, AU - Madhusudhan,Santhosh Kumar, AU - Ravish,Haradanahalli Shankariah, Y1 - 2010/04/18/ PY - 2009/08/20/received PY - 2010/03/06/revised PY - 2010/03/26/accepted PY - 2010/4/21/entrez PY - 2010/4/21/pubmed PY - 2010/8/28/medline SP - 4086 EP - 90 JF - Vaccine JO - Vaccine VL - 28 IS - 24 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20403351/Immunogenicity_and_safety_study_of_Indirab:_a_Vero_cell_based_chromatographically_purified_human_rabies_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)00464-0 DB - PRIME DP - Unbound Medicine ER -