COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000390-En

Francisco Hernandez Bernal

hernandez.bernal@cigb.edu.cu

2021-09-03

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

unclear

Prevention

1) Age between 3 and 18 years at the time of inclusion.2) General physical examination and by appliances without alterations at the time of inclusion.3) Nutritional assessment: weight / height ratio between 10 and 90 percentile (for children between 3 and 9 years of age). Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years old, according to the cut-off points for the Cuban pediatric population.4) Voluntariness of both parents (or legal guardian) by signing the informed consent, as well as informed consent for adolescents aged =12 years.

1) History of SARS-CoV-2 infection or with this diagnosis at the time of inclusion in the study.2) Contact or suspect of COVID-19 at the time of inclusion.3) Body temperature = 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours).4) Acute infectious disease in the three days prior to the application of the vaccine.5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.6) History of having received a vaccine against SARS-CoV-2 or against other coronaviruses.7) Have received any other vaccine, in the 14 days prior to the administration of each dose.8) Administration of any research product in the last 30 days or that its use is planned during the clinical trial.9) Having been treated in the last 30 days or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study.10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study.11) Known hypersensitivity to thiomersal and to any of the components of the vaccine under study.12) Tattoos in both deltoid regions that interfere with the injection site safety assessment.13) History or suspicion of alcoholism or drug dependence.14) Positive urine pregnancy test, before the administration of any of the three doses in women with biological capacity to have a pregnancy (history of menarche).

1

Center for Genetic Engineering and Biotechnology (CIGB); in Havana.

3

18

Cuba

Healthy volunteers

N/A

700

Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that = 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time.

Phase 2

[{"arm_notes": "", "treatment_id": 1975, "treatment_name": "Cigb-66", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]