Resumo

POVEA MORA, Yanet; GIL DEL VALLE, Lizette; RABEIRO MARTINEZ, Carlos Luis  e  PLANAS VALDES, Caridad. COMPLIANCE WITH NURSING ACTIVITIES IN CLINICAL TRIALS OF VACCINE CANDIDATES TO CONFRONT HIV/AIDS INFECTION AT THE INSTITUTE OF TROPICAL MEDICINE. Rev. CENIC Cienc. Biol [online]. 2023, vol.54, pp. 232-239.  Epub 25-Dez-2023. ISSN 2221-2450.

The use of antiretroviral therapy to treat HIV infection may condition the long-term occurrence of various complications and pathologies, which can affect not only quality of life but also the need to modify the patient's treatment regimen. The development achieved in the field of vaccines makes them an effective option for the treatment of HIV in the future. At the Institute of Tropical Medicine, two clinical trials have been developed with the participation of nurses in the period 2010-2019: the therapeutic vaccine candidate for HIV TERAVAC HIV-1 and the immunopotentiator vaccine candidate NacGM3. The aim of the study was to describe the activities accomplishment of nursing professionals in clinical trials with therapeutic vaccine candidates. Each clinical trials had particularities defined in protocol. Sixteen nurses participated, using subcutaneous parenteral administration of the vaccine candidate products and intranasal simultaneous administration of TERAVAC HIV-1. The latter trial lasted 40 weeks, with six applications. In case of NAcGM3/ VSSP vaccine candidate, vaccination was carried out for one year, applying 15 doses. In both cases, an observance guide related to clinical symptomatology, identification and treatment of adverse reactions, observance of biosafety and good clinical practices monitored nursing activities. The nursing protocols were complied totally with the participation of the 16 nurses. The interaction in the protocols was carried out with 200 patients, with 120 patients completing the studies. The data observed integrated the final report of the studies for regulatory (CECMED) and coordinators centers (CENCEC). The administration of each candidate constituted for the nursing staff one of the major responsibilities they assumed in their interaction with the patient, as well as other clinical essential actions for the performance of the trials.

Palavras-chave : HIV; vaccine; clinical trial; nursing.