Cuba will evaluate the safety and immunogenicity of the vaccine candidate Mambisa and the Abdala vaccine with people who suffered from COVID-19
The Cuban Center for State Control of Medicines, Equipment and Medical Devices approved the phase I/II clinical trial to evaluate the safety and immunogenicity of the vaccine candidate Mambisa -intranasal- and the Abdala vaccine -intramuscular-, a study to boost immunity in convalescents of COVID-19.
The information, published at the Cuban Public Registry of Clinical Trials, refers that the study will be carried out at the “Hermanos Ameijeiras” Surgical Clinical Hospital in Havana, the sample size will be 120 participants and there will be four groups in stage I and two in stage II.
In stage I, three groups will receive a single dose of Mambisa: one by means of a nasal spray (one spray in each nostril); another one by means of nasal drops; and a third one, with a Cuban prototype nasal spray; while the fourth group will receive Abdala intramuscularly in the deltoid region, single dose.
Likewise, in phase II, the vaccine candidate Mambisa (CIGB-669) will be used in one segment of the sample, in the selected variant, and Abdala (CIGB-66) in another, in both cases single doses.
Volunteers must be between 19 and 80 years of age, be convalescing from COVID-19, at least two months after discharge, and have expressed prior consent to the study.
Detecting and characterizing serious and unexpected adverse events associated with the administration of the vaccine candidate, as appropriate, is one of the specific objectives of the trial.
With the study, more than 55 % of patients treated with both drugs are expected to have a fourfold or greater increase in baseline IgG-specific antibody titers, the Public Registry noted.
Mambisa is the only Cuban anti-COVID-19 vaccine candidate that is administered nasally, and is based on the technological platform of recombinantly produced antigens, whose main advantages are safety and the possibility of administering multiple doses, in order to reinforce the immune response over time.