Phase I / II clinical trial to evaluate the safety and immunogenicity of vaccine candidates X and Y (tp) intramuscularly. Study to boost immunity in convalescent subjects of the viral disease COVID-19

Center for Genetic Engineering and Biotechnology (CIGB)0 sites120 target enrollmentJuly 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2021

End Date

December 27, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Center for Genetic Engineering and Biotechnology (CIGB)

•1\. Subjects aged between 19 and 80 years, both inclusive.
•2\. Subjects convalescing from COVID\-19 with at least 2 months of being discharged.
•3\. Subjects who express, in writing, their consent to participate in the study.

•1\. Subjects with a current confirmed history of COVID\-19 \+.
•2\. Subjects considered contacts or suspects of COVID\-19 at the time of inclusion.
•3\. Subjects who report any of the following symptoms:
•\- cough or shortness of breath,
•\- loss of smell (anosmia),
•\- loss of taste (ageusia) or
•\- acute infection during the 15 days prior to inclusion
•4\. Subjects with decompensated chronic diseases at the time of inclusion.
•5\. Subjects with a finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow\-up (Example: chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nasal tumors such as polyposis and squamous cell carcinoma).
•6\. Subjects with tattoos in both deltoid regions that make it difficult to see the injection site, taking into account the random nature of the treatment assignment.