The New Drugs Advisory Committee of Vaccine, the expert committee under the Drug Controller General of India (DCGI), has recommended permission to the phase I clinical trial application of diphtheria, tetanus, acellular pertussis (DTaP) vaccine by Serum Institute of India, Pune.
“Committee recommended to give the permission to conduct the phase I clinical trial with the condition to submit the data on the age group of 4-6 years of age for satisfactory evaluation by this office, before conducting the study in lower age group,” according to official sources.
With regard to the proposal for Institutional Clinical Trial of lactobacillus brevis CD2 nasal drops by Dr Vasantha, ICMR, New Delhi, the panel said no safety and efficacy data was provided by applicant on the trial drug in animals. The committee recommended that the safety and efficacy data on animals needs to be generated before the permission is granted to carry out the study in humans.
In the case of application to manufacture and market INDIRAB (Chromatogarphically Purified, Inactivated, Lyophilized Rabies Vaccine, prepared on Vero Cells) by Bharat Biotech International Limited, Hyderabad, the expert panel reviewed the data and it was noted that in the text of report there was some discrepancy in the dose of the drug (either 3 or 4 dose given to subjects), which was explained by the firm to be typographical error so the committee recommended to again submit the report with the corrected data and table. It will be reviewed in the next NDAC (Vaccine) meeting.
Novartis Healthcare, which submitted the proposal for permission to import and market of purified chick embryo fibroblast Rabies vaccine (Rabipur), however later requested defer the proposal. The panel gave permission to conduct phase I trial; with indigenously developed Varicella Vaccine, Live, I.P. (BIOPOX) manufactured by Bio-Med (P) Ltd, Ghaziabad, subject to the condition of submission of revised informed consent Form and to submit the revised undertaking of principal investigator.
The panel also recommended permission to market for new additional indication i.e. Cervarix (HPV) vaccine for use from the age of 9 year for prevention of premalignant cervical lesions and cervical cancer casually related to certain oncogenic Human Papilloma Virus (HPV) type. Another proposal which got the approval was for manufacturing and marketing of bivalent Oral Polio Vaccine (bOPV, Type 1and Type 3) I.P. by BIBCOL, Bulandshehar.
“Committee Recommended for the Market Authorization subject to conduct and the submission of phase IV protocol on 1000 subjects and with the direction to submit the interim report on 500 subjects to this office for evaluation,” the sources said.
The panel also gave nod for granting permission to conduct phase II/III Clinical trial to Assess the Safety and Immunogenicity of SIIL’s Purified Vero Cell Rabies Vaccine (PVRV) in Patients with Potential Rabies Exposure”, subject to condition to submit the interim data of category 2 subjects on 45 subjects before going in category 3.
Another proposal was for permission to conduct a phase II clinical trial of VGX-3100 by M/a Max Neeman International Ltd, New Delhi. “Committee recommended to give the permission to conduct phase II clinical trial subject to the conditions: the blood samples of trial subjects should be collected according to ICMR guidelines; and the trial batch of vaccine should be tested from CDL, Kasauli before initiation of study.”
Another proposal was for permission to conduct a phase III clinical trial of an EGF cancer vaccine by Indipharm (India) Pvt Ltd, Mumbai. The committee recommended phase III trial with the conditions that standard of care should be given free of cost to the trial subjects; the trial batch of vaccine should be tested from CDL, Kasauli before initiation of study; and the firm is required to obtain clearance from GEAC before permission to conduct the trial is granted.
The panel also recommended grant of permission to manufacture Typhoid (Vi Capsular Polysaccharide) - Tetanus Toxoid Conjugate vaccine. “Committee recommended to grant the market authorization with the condition to follow up the subjects included in the clinical trial for up to Three years for evaluation of safety and efficacy as part of PMS study and submit the report to DCGI office,” according to the minutes of the meeting.