CDE: Technical Guidelines for Immunogenicity Bridging Clinical Trials of Vaccines for Prevention (Draft for Comments) for comments

On December 21, the Center for Drug Evaluation of the State Food and Drug Administration publicly solicited comments on the "Technical Guidelines for Clinical Trials of Immunogenicity Bridging Clinical Trials of Preventive Vaccines (Draft for Comments)", and the time limit is one month
from the date of issuance.

Immunogenicity is one of the important means of vaccine evaluation for prevention, and the immune response and safety characteristics caused by vaccines under different conditions can be compared through immunogenicity bridging clinical trials (referred to as immunobridging tests), and the safety and efficacy
of vaccines can be speculated and referenced.

Prophylactic vaccines are usually assessed for benefit by means of protective efficacy tests and immunogenicity tests
.
Immunogenicity trials typically use validated immunogenicity indicators to measure the level of adaptive immunity, some of which are supported by clear scientific principles and clinical data, have been shown to directly predict clinical benefit, and can be used to support routine registration; Some immunogenicity indicators have certain mechanisms and supporting evidence, and the association with protective efficacy has not been clearly established, but it can be speculated that they have a certain correlation
with clinical benefit.
If the vaccine has obtained evidence of protective efficacy and plans to carry out extrapolated population, dose exploration, immune program changes, pharmaceutical changes, etc.
, it is considered to carry out immunogenicity bridging clinical trials based on the above immunogenicity indicators that have clearly had protective relevance or have a certain degree of protective correlation, and compare the immune response caused by the vaccine under different conditions to predict the safety and efficacy
of the vaccine.

The guidelines apply to immunization bridging trials for vaccines for which evidence of protective efficacy has been obtained, including bridging of extended age range, bridging of changes in immunization schedules, bridging between domestic and foreign populations, bridging of pharmaceutical changes, and other applicable situations
.

Notice on the public solicitation of comments on the Technical Guidelines for Clinical Trials of Immunogenicity Bridging of Vaccines for Prevention (Draft for Comments).

Immunogenicity is one of the important means of vaccine evaluation for prevention, and the immune response and safety characteristics caused by vaccines under different conditions can be compared through immunogenicity bridging clinical trials (referred to as immunobridging tests), and the safety and efficacy
of vaccines can be speculated and referenced.
Immunobridging test has specific application fields and design characteristics, in order to guide applicants to carry out standardized immunobridging test scientifically and reasonably, our center has written the "Technical Guidelines for Immunogenicity Bridging Clinical Trials of Preventive Vaccines (Draft for Comments
)".

We sincerely welcome all sectors of the community to put forward valuable comments and suggestions on the draft for comments, and feedback to us in time for subsequent improvement
.
The time limit for soliciting comments is 1 month
from the date of publication.

Your feedback should be sent to the email address of the following contact person:

Contact: Yin Xiao, Liu Bo

Contact: yinx@cde.
org.
cn, liub@cde.
org.
cn

Thank you for your participation and great support
.

Center for Drug Evaluation, State Medical Products Administration

November 21, 2022

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