The drug is one of the four Cuban vaccine candidates in clinical trials and the second to reach that phase.
Jan 28 (teleSUR) The anti-covid vaccine candidate CIGB 66, known as Abdala, advances to phase II of clinical trials, starting next February 1 at the Saturnino Lora provincial hospital in Santiago de Cuba, the hospital’s director told a local news agency on Thursday.
Rafael Suarez, director of the Santiago hospital (900 km southeast of Havana), where phase I of the clinical trials took place, said in an interview with the Cuban News Agency that the new stage of the study would have approximately 800 volunteers, coming from labor and student centers of the main municipality, to guarantee better control and permanence in the research.
Likewise, the doctor pointed out the extension of the participants’ age range, between 19 and 80 years old, who can be healthy or with complicated pathologies.
The next phase will start after the approval of the Center for the State Control of Medicines, Equipment, and Medical Devices (Cecmed) and independent provincial and national neutral observers, which do not belong to the Saturnino Lora hospital nor the Center for Genetic Engineering and Biotechnology (CIGB). This entity created Abdala, he specified.
A week ago, Eduardo Martínez, director of BioCubaFarma, an entity that groups the research, development, production, and commercialization institutes of biotechnological drugs, announced that the independent committee for the analysis of data from the Abdala clinical study had evaluated the first results of safety and immunogenicity of this CIGB vaccine candidate. “Progress continues to be made,” he said at the time.
“Abdala Vaccine Candidate Advances to Phase II Clinical Trial”
The decision to move forward comes after learning that there were “few adverse reactions in the 132 participants in the first test cycle and an adequate safety profile,” according to Suarez while recalling that this drug is applied intramuscularly and “exhibits a positive immunological response, although the investigations continue.”
Abdala, from CIGB, together with Soberana 02, from the Finlay Vaccine Institute, are the two of the four vaccine candidates against Covid-19 produced in Cuba that are progressing to the second stage of clinical trials, in which the safety and capacity to create antibodies in several hundred people are being explored.
Cuba has bet on its own vaccine and announced that with the most advanced one, Soberana 02, immunization of risk groups could begin at the end of the first trimester.