Last Updated on December 31, 2023 by The Health Master
Clinical Trial
In a significant development in the world of vaccines, the Subject Expert Committee (SEC) on vaccines, responsible for evaluating proposals and advising the Drugs Controller General (India) (DCGI) on matters related to biologicals, has given its nod to Gujarat-based Cadila Pharmaceuticals for conducting a phase I clinical trial of their chickenpox vaccine.
This groundbreaking decision came after a meticulous review of Cadila’s revised clinical trial protocol for the Varicella-Zoster Virus (VZV) vaccine.
The SEC’s recommendation, made during a meeting held on September 14, 2023, paves the way for an exciting new phase in the fight against chickenpox.
The Journey to Phase I Approval of Chickenpox Vaccine
Cadila Pharmaceuticals had initially submitted their proposal for a Phase I clinical trial of the Varicella-Zoster virus (VZV) chickenpox vaccine, accompanied by preclinical data.
This submission was evaluated during a previous SEC meeting on May 16, 2023.
At that time, the SEC, following thorough deliberation, advised Cadila to provide single-dose toxicity data, as required by the New Drugs and Clinical Trials Rules of 2019.
Additionally, they suggested that Cadila revise the phase I clinical trial protocol, including modifications such as the volume of blood to be withdrawn for analysis.
Understanding the Importance of the VZV Vaccine:
Varicella, commonly known as chickenpox, is a highly contagious disease caused by the Varicella-Zoster Virus (VZV), a member of the herpesvirus family.
The World Health Organization (WHO) emphasizes the significance of understanding this virus, stating that only one serotype of VZV exists, with humans as the sole reservoir.
Following infection, the virus enters a latent state in the neural ganglia.
In approximately 10–20% of cases, it can reactivate, leading to herpes zoster, or shingles, primarily affecting individuals over 50 years of age or those with compromised immune systems.
Evolution of Varicella Vaccines:
The WHO highlights that current varicella vaccines are attenuated vaccines derived from the Oka VZV strain, which has been modified through sequential propagation in various cell cultures.
This attenuated strain is cultivated in cell culture, purified, and then lyophilized before being administered via subcutaneous injection.
Additionally, there is a combination vaccine available, which includes varicella along with measles, mumps, and rubella (MMRV).
Furthermore, a vaccine containing higher virus levels has been developed specifically for the prevention of shingles in the elderly.
Cadila Pharmaceuticals’ Impressive Track Record:
It’s worth noting that Cadila Pharmaceuticals has made significant strides in the field of vaccine development.
In April 2022, the company achieved a remarkable milestone by launching the world’s first novel three-dose rabies vaccine, known as ThRabis.
This remarkable accomplishment underscores Cadila’s commitment to advancing healthcare through innovative vaccine solutions.
Conclusion:
The SEC’s approval for Cadila Pharmaceuticals to proceed with a phase I clinical trial for their chickenpox vaccine is a testament to the company’s dedication to public health and medical innovation.
As the journey towards developing effective solutions for varicella continues, the world watches with anticipation, hopeful for a future with improved protection against this highly contagious and potentially debilitating disease.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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