Evaluation of the safety and immunogenicity of the vaccine candidate CIGB-66 against SARS-CoV-2. (COVID-19)

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 sitesNovember 26, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 26, 2020

End Date

June 30, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Center for Genetic Engineering and Biotechnology (CIGB), in Havana

•1\) Individuals aged between 19 and 54 years, both inclusive (for phase I) and between 19 and 80 years old, both inclusive (for phase II).
•2\) Physical examination without significant alterations.
•3\) Hematological and blood chemistry determinations within or outside normal ranges, without clinical relevance (only for phase I).
•4\) Voluntariness of the subject by signing the informed consent.

•1\) Virological diagnosis by RT\-PCR of infection to SARS\-CoV\-2\.
•2\) Contact or suspect of COVID\-19 at the time of inclusion.
•3\) Subjects at high risk of exposure to SARS\-CoV\-2 infection (contacts of confirmed cases, health workers in the 1st line of medical care \[Emergency, ICU, other risk areas]).
•4\) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia.
•5\) Chronic, autoimmune or endocrine\-metabolic diseases decompensated at the time of inclusion.
•6\) Body mass index \=18 or \= 35 Kg / m2\.
•7\) Subjects with tattoos in both deltoid regions.
•8\) Administration of any research product in the last three months.
•9\) Subject treated in the last three months or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid or cytostatic, during the study.
•10\) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study.