Zydus Lifesciences Gets CDSCO Panel nod to study Bivalent Typhoid and Paratyphoid A Conjugate Vaccine
New Delhi: Reviewing the Phase I clinical trial protocol of the vaccine Bivalent Typhoid and Paratyphoid A Conjugate Vaccine, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major Zydus Lifesciences to submit the revised protocol of the proposed vaccine.
This came after Zydus Lifesciences presented the Phase I clinical trial protocol titled “An open- label, single-treatment, single- period, single dose, clinical phase 1 study to assess the safety and tolerability of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine (BTPT) of Zydus Lifesciences, India in healthy, adult human subjects” along with pre-clinical study report of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine.
The vaccine candidate is under development for the prevention of typhoid fever and paratyphoid A fever. It is a bivalent conjugate vaccine of S.typhi and S.paratyphi A serotypes. The vaccine is administered through an intramuscular route.
The vaccine candidate is under development for the prevention of typhoid fever and paratyphoid A fever. It is a bivalent conjugate vaccine of S. typhi and S. paratyphi A serotypes.
Salmonella Typhi and Salmonella Paratyphi A, collectively known as typhoidal Salmonella, are causal agents for a serious, invasive (bacteraemic), sometimes fatal disease of humans called typhoid fever or paratyphoid fever (also called enteric fevers).
At the recent SEC meeting for Vaccine held on March 27th, 2024, the expert panel reviewed the Phase I clinical trial protocol titled “An open- label, single-treatment, single-period, single dose, clinical phase 1 study to assess the safety and tolerability of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine (BTPT) of M/s Zydus Lifesciences Ltd., India in healthy, adult human subjects” along with pre-clinical study report of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine.
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase-I clinical trial of Bivalent Typhoid and Paratyphoid A conjugate vaccine with the condition to make screening up to day -14 instead of day - 28.
Accordingly, the expert panel suggested that the firm should submit a revised protocol to CDSCO.
