Havana, Cuba: Scientists from the Center for Genetic Engineering and Biotechnology (CIGB by its Spanish initials) have completed one of the first steps in phase I clinical trials of their anti-Covid-19 vaccine candidates, study leaders announced today, Prensa Latina publishes.
The institution carries out two studies, Mambisa, which explores the nasal route, and Abdala the intramuscular one.
The first of them uses the HBsAg protein from the hepatitis B virus, the basis of the Cuban vaccine against this pathogen: HeberNasvac, as an antigen.
Mambisa completed the so-called short study time stipulated for days zero, 14 and 28, explained Miladys Limonta, manager of the trial.
This research, which began the first immunizations on December 7 at the Carlos J. Finlay hospital in this capital, has a sample size of 88 volunteers divided into four groups in which the different routes of administration will be analyzed: intramuscular and the intranasal.
Initially, its members received an intramuscular dose of the drug and another two intra-anally, while another group received three administrations at the same site. After this first period, the processing of the samples remains and the safety of the drug could be verified as there were only mild adverse reactions, Limonta said.
Once the evaluation by the regulatory entity is completed, we will move on to the length of the study, between days zero, 28 and 56, the scientist explained.
Meanwhile, the second anti-Covid-19 candidate of the CIGB, Abdala, also finished his short cycle that evaluates the dose ranges in a period of zero, 14 and 28 days.
Developed at the Saturnino Lora hospital in the eastern province of Santiago de Cuba, it is made up of 132 volunteers, who receive two doses of the antigen and placebo intramuscularly.
The CIGB’s anti-Covid-19 vaccines complete Cuba’s quartet of proposals to achieve immunization of its population against this disease.
The first two, Soberana 01 and 02, are also making good progress, their developers from the Finlay Vaccine Institute say. (BSH)