Estudios clínicos

The purpose of this study is to define the safety and immunogenicity of IHV01 and A244/AHFG with and without ALFQ at a full dose and at a fractional dose (one-fifth of a full dose) in a late boost setting for participants who had previously received a late boost of AIDSVAX®B/E with or without ALVAC in RV306. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood, lymph nodes, sigmoid tissue, and mucosal specimens/secretions will be collected to assess humoral, cell-mediated, innate, and mucosal immune responses. Healthy, HIV-uninfected participants, at a low risk for HIV infection, available for 12 months, who were randomized to receive active vaccine in RV306 and completed all vaccinations will be enrolled. A total of 120 participants will be enrolled across four vaccination groups. In each group, 25 participants will receive IHV01 and A244/ AHFG at a full or fractional dose with or without ALFQ and 5 participants will receive placebo. All injections, whether vaccine or placebo, will be a one-time intramuscular (IM) administration into the quadriceps muscle at study Day 0. Participants will be followed-up for up to 48 weeks after enrollment on days 1, 7, 14, 168 and 336. Mucosal secretion collections and endocervical cytobrush/swab procedures will be performed at Weeks 0, 2, 24, and 48 on consenting participants. Leukapheresis, sigmoid biopsy, and lymph node biopsy
procedures will be performed only at Week 2 on consenting participants.

Clinical trial to evaluate the distribution of ABX464 and its main metabolite (N-Glu) in various compartments in HIV-1 Seronegative and Seropositive adult subjects.

Cohorte prospectiva de personas voluntarias sanas, de las cuales se conozca de forma documentada su estado seronegativo por el VIH y genotipo HLA de alta resolución y al mismo tiempo se dispongan muestras biológicas (plasma y PBMC) almacenadas en el biobanco del laboratorio de retrovirología del Instituto de Investigación del Sida IrsiCaixa para su uso en el estudio de aspectos inmunológicos de la infección por el VIH y sus enfermedades relacionadas.

Older adults have been disproportionately affected by the COVID-19 pandemic. Among them, residents from long-term care facilities (LTCF), who live in a congregate setting (with increased risk of transmission and infection) showed higher mortality rates than the general population of the same age. Therefore, vaccination of residents from LTCF against SARS-CoV-2 has been a priority in most countries. Ageing is associated with an immunosenescent phenotype characterized by a progressive increase of a proinflammatory state and, a diminished immune response to pathogens and vaccines. Therefore, there is an urgent need to determine the quality and the duration of immune responses of the elderly population, which could be very useful for designing specific SARS-CoV-2 vaccination calendars adapted to their immune needs. The aim of the study is to evaluate the quality and the duration of immune response generated by SARS-CoV-2 Vaccine in institutionalized elders living on LTCF, comparing individuals recovered from SARS-CoV-2 infection with elders who never got infected by SARS-CoV-2 living in the same senior facilities. In addition, we will compare the immune responses generated by elders with a younger population.

Pooling testing combes the same type of specimen from several people and conducting one NAAT laboratory test on the combined pool of specimens to detect SARS-CoV-2. Pooled tests that return positive results will require each specimen in the pool to be retested individually to determine which individual(s) are positive. The advantages of pooling include preserving testing reagents and resources, reducing the amount of time required to test large numbers of specimens (increasing throughput), and lowering the overall cost of testing. The aim of the study is to determine if pool testing is an efficient technique that could be used to identify SARS-CoV-2 infected individuals rapidly and at lower cost. Disse

The study included 28 patients this year, reaching a total of 40 people recruited.

Assaig clínic en fase II per avaluar l’efecte del durvalumab (MEDI4736) en pacients VIH-positius amb tumors sòlids avançats. 

El ensayo clínico BCN02-Romi es un estudio de erradicación que evaluará la eficacia de una estrategia de Kick & kill usando las vacunas terapéuticas que se han demostrado más inmunogénicas hasta el momento (HIVconsv) en combinación con el fármaco reactivador de la latencia viral más potente disponible en este momento (RMD, Romidepsina). Las personas VIH positivas que han sido tratadas de forma precoz y que han sido previamente vacunadas en el ensayo clínico BCN01 representan un grupo ideal para demostrar la eficacia de esta estrategia combinada en la reducción del reservorio viral y en el control del rebote viral una vez retirado el tratamiento. En este estudio, y mediante el desarrollo de un análisis poblacional PK/PD, se investigará en profundidad la relación entre los niveles de romidepsina y los efectos in-vivo en la inducción de la expresión del VIH del reservorio, así como el impacto en el sistema inmunitario. Los resultados del estudio permitirán optimizar las dosis de RMD e identificar marcadores que ayuden a comprender la eficacia de las estrategias de erradicación actualmente en estudio.

Cohorte prospectiva de seguimiento de individuos con infección aguda/reciente del VIH-1 documentada y que inician tratamiento de forma precoz. El objetivo radica en disponer de una plataforma clínica de personas candidatas a participar en ensayos clínicos de vacuna terapéutica y estrategias de erradicación y al mismo tiempo disponer de muestras biológicas de forma prospectiva desde el inicio de la terapia antirretroviral para estudiar, en los fenómenos iniciales de la transmisión del VIH, respuesta inmunológica, establecimiento del reservorio viral y cambios en el microbioma intestinal. No se realiza ninguna intervención clínica, más allá de la obtención de muestras biológicas adicionales y la recolección de heces.