Vaccines

As per the New Drugs and Clinical Trials Rules, 2019, vaccines are considered as “New drugs” and thus follow the same regulatory aspects as chemical drugs for clinical trial conduction. Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use.


GroupDiscussion

Vaccines

As per the New Drugs and Clinical Trials Rules, 2019, vaccines are considered as “New drugs” and thus follow the same regulatory aspects as chemical drugs for clinical trial conduction. Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use.

Conducting Vaccine Clinical Trials in India

Clinical trials require regulatory and ethical oversight to ensure the protection of the trial participants as well as to ensure the scientific integrity of the resulting data. In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for approval of novel vaccines and with this it ensures the safety, efficacy and quality of the marketed vaccines.

Process of Obtaining Clinical trial NOC in India

SUGAM is an online web portal where applicants can apply for No objection certificates (NOCs) to conduct clinical trials.

For any clinical trial, the study sponsor is the responsible person and has all the information. For initiating clinical trials, sponsors needs to submit the application by filling Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019. The data required will depend upon the type of application, phase of the study, stage in drug development process, and/or objective of the study.

Three Phases of Vaccine Development

A vaccine candidate should go through three phases of development in humans - Phase I, Phase II, and Phase III. After successful completion of Phase III trials and following licensure of the product, Phase IV studies or postmarketing surveillance studies (PMS) are carried out for systematic monitoring of the vaccine for safety and effectiveness in the real world.

Phase I or first-in-man studies refer to the first administration of a vaccine candidate to humans. Phase I are conducted to evaluate the safety, reactogenicity and immunogenicity aspects of the vaccines. In some instances, the dose, immunization schedule and mode of vaccine administration are also assessed in this phase.

After a vaccine candidate shows satisfactory results in Phase I, the next step is Phase II studies. The main objective of phase II study is to identify the vaccine preparation, optimal dose, and schedule to be taken up for Phase III trials or confirmatory trials. Phase II studies have the desired statistical power and a defined sample size, and hence are intended to provide a clinically meaningful outcome on the safety, immunogenicity, and efficacy end points.

Pivotal Phase III trials are designed to evaluate efficacy and safety of the proposed vaccine. Phase III trials are important for registration and approval to market of a vaccine and are required to confirm the effect of the final formulation. Phase III trials involve large scale testing and enroll thousands of subjects from the target population. Once the vaccine candidate demonstrate optimal efficacy and safety in phase III trials, the manufacturer of the vaccine can submit an application to the national regulatory authority to license and market the product.

The permission to initiate clinical trial is granted in Form CT-06 by the central licensing authority and automatic approval is granted in Form CT 4A. The approval is valid for a period of 2 years from the date of its issue, unless extended by the central licensing authority. Clinical trial shall be initiated by enrolling the first subject within a period of 2 year from the date of grant of permission, failing which the sponsor should get prior permission from CLA before initiating the trial.

Before enrolling the first subject for the trial, clinical trial needs to be registered with the Clinical Trial Registry. Clinical trial can be initiated at the site only after getting approval letter by the registered Ethics Committee.

Cliniexperts can help you in effectively navigating through the various regulations and steps involved in vaccine clinical trials. CliniExperts provide full spectrum services for local and global clinical trial- Phase I Trial,Phase II Trial,Phase III Trialand Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India). Make Cliniexperts your partner to bring novel vaccines to save lives and promote global welfare.

Summary

  • A vaccine candidate should go through three phases of development in humans - Phase I, Phase II, and Phase III.

  • For initiating the clinical trial, the sponsor needs to submit the application by filling Form CT-04. The permission to initiate clinical trial is granted in Form CT-06 by the central licensing authority and automatic approval is granted in Form CT 4A.

  • Before enrolling the first subject for the trial, clinical trial needs to be registered with the Clinical Trial Registry. Clinical trial can be initiated at the site only after getting approval letter by the registered Ethics Committee.

References

  • New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

  • Singh K, Mehta S. The clinical development process for a novel preventive vaccine: An overview. J Postgrad Med. 2016;62(1):4‐11.

Send us your Enquiry by filling the form below


*All the above fields are mandatory

Frequently Asked Questions

In which cases the extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible?

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.



Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use.

Vaccines

As per the New Drugs and Clinical Trials Rules, 2019, vaccines are considered as “New drugs” and thus follow the same regulatory aspects as chemical drugs for clinical trial conduction. Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use.

Conducting Vaccine Clinical Trials in India

Clinical trials require regulatory and ethical oversight to ensure the protection of the trial participants as well as to ensure the scientific integrity of the resulting data. In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for approval of novel vaccines and with this it ensures the safety, efficacy and quality of the marketed vaccines.

Process of Obtaining Clinical trial NOC in India

SUGAM is an online web portal where applicants can apply for No objection certificates (NOCs) to conduct clinical trials.

For any clinical trial, the study sponsor is the responsible person and has all the information. For initiating clinical trials, sponsors needs to submit the application by filling Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019. The data required will depend upon the type of application, phase of the study, stage in drug development process, and/or objective of the study.

Three Phases of Vaccine Development

A vaccine candidate should go through three phases of development in humans - Phase I, Phase II, and Phase III. After successful completion of Phase III trials and following licensure of the product, Phase IV studies or postmarketing surveillance studies (PMS) are carried out for systematic monitoring of the vaccine for safety and effectiveness in the real world.

Phase I or first-in-man studies refer to the first administration of a vaccine candidate to humans. Phase I are conducted to evaluate the safety, reactogenicity and immunogenicity aspects of the vaccines. In some instances, the dose, immunization schedule and mode of vaccine administration are also assessed in this phase.

After a vaccine candidate shows satisfactory results in Phase I, the next step is Phase II studies. The main objective of phase II study is to identify the vaccine preparation, optimal dose, and schedule to be taken up for Phase III trials or confirmatory trials. Phase II studies have the desired statistical power and a defined sample size, and hence are intended to provide a clinically meaningful outcome on the safety, immunogenicity, and efficacy end points.

Pivotal Phase III trials are designed to evaluate efficacy and safety of the proposed vaccine. Phase III trials are important for registration and approval to market of a vaccine and are required to confirm the effect of the final formulation. Phase III trials involve large scale testing and enroll thousands of subjects from the target population. Once the vaccine candidate demonstrate optimal efficacy and safety in phase III trials, the manufacturer of the vaccine can submit an application to the national regulatory authority to license and market the product.

The permission to initiate clinical trial is granted in Form CT-06 by the central licensing authority and automatic approval is granted in Form CT 4A. The approval is valid for a period of 2 years from the date of its issue, unless extended by the central licensing authority. Clinical trial shall be initiated by enrolling the first subject within a period of 2 year from the date of grant of permission, failing which the sponsor should get prior permission from CLA before initiating the trial.

Before enrolling the first subject for the trial, clinical trial needs to be registered with the Clinical Trial Registry. Clinical trial can be initiated at the site only after getting approval letter by the registered Ethics Committee.

Cliniexperts can help you in effectively navigating through the various regulations and steps involved in vaccine clinical trials. CliniExperts provide full spectrum services for local and global clinical trial- Phase I Trial,Phase II Trial,Phase III Trialand Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India). Make Cliniexperts your partner to bring novel vaccines to save lives and promote global welfare.

Summary

  • A vaccine candidate should go through three phases of development in humans - Phase I, Phase II, and Phase III.

  • For initiating the clinical trial, the sponsor needs to submit the application by filling Form CT-04. The permission to initiate clinical trial is granted in Form CT-06 by the central licensing authority and automatic approval is granted in Form CT 4A.

  • Before enrolling the first subject for the trial, clinical trial needs to be registered with the Clinical Trial Registry. Clinical trial can be initiated at the site only after getting approval letter by the registered Ethics Committee.

References

  • New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

  • Singh K, Mehta S. The clinical development process for a novel preventive vaccine: An overview. J Postgrad Med. 2016;62(1):4‐11.

Frequently Asked Questions

In which cases the extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible?

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.


*All the above fields are mandatory
Enquire now