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Evaluating a Combination of Immune-based Therapies to Achieve a Functional Cure of HIV Infection


HIVACAR Phase I/IIa clinical trial protocol

HIVACAR Phase I/IIa clinical trial protocol: A document containing the description of the clinical trial, the research brochure and all other documents requested by the MEC’s for all sites of clinical intervention.

Data Management Plan

The Data Management Plan will be prepared at month 12 and an updated version will be delivered at month 30.

Final Briefing Document sent to EMA to request Scientific Advice containing information on the quality, nonclinical and clinical development program

Final Briefing Document sent to EMA to request Scientific Advice containing information on the quality, nonclinical and clinical development program

Intermediate report on dissemination activities

Intermediate report on dissemination activities: A detailed list of dissemination activities carried out halfway through the project, with assessment of their impact, the degree of compliance with the plan, and a description of foreseen dissemination activities until the end of the project.

Targeted communication tools

Targeted communication tools: This deliverable includes tools such as: 1) The review and adaption of the clinical trial synopsis and informative materials to be shared with the participants and the community; 2) Creation of leaflets and other informative materials informing on the project objectives and expected outcomes; 3) The creation of a communication tool (such as an online forum) where the patients enrolled in the clinical trial can raise questions regarding the trial development, share their concerns and expectations regarding their participation. The tool will also allow monitoring and prevent possible dropouts and to manage expectations regarding the outcomes of the project.

Communication plan

Communication plan: This document will describe in detail the project communication strategy in all of its components: objectives, audiences, actions and tools.

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Off the beaten path: Novel mRNA-nanoformulations for therapeutic vaccination against HIV

Author(s): Sigrid D’haese, Céline Lacroix, Felipe Garcia, Montserrat Plana, Simona Ruta, Guido Vanham, Bernard Verrier, Joeri L. Aerts
Published in: Journal of Controlled Release, Issue 330, 2021, Page(s) 1016-1033, ISSN 0168-3659
DOI: 10.1016/j.jconrel.2020.11.009

Antiretroviral Therapy Interruption (ATI) in HIV-1 Infected Patients Participating in Therapeutic Vaccine Trials: Surrogate Markers of Virological Response

Author(s): Lorna Leal, Csaba Fehér, Valèria Richart, Berta Torres, Felipe García
Published in: Vaccines, Issue 8/3, 2020, Page(s) 442, ISSN 2076-393X
DOI: 10.3390/vaccines8030442

A Novel MVA-Based HIV Vaccine Candidate (MVA-gp145-GPN) Co-Expressing Clade C Membrane-Bound Trimeric gp145 Env and Gag-Induced Virus-Like Particles (VLPs) Triggered Broad and Multifunctional HIV-1-Specific T Cell and Antibody Responses

Author(s): Beatriz Perdiguero, Cristina Sánchez-Corzo, Carlos Oscar S. Sorzano, Lidia Saiz, Pilar Mediavilla, Mariano Esteban, Carmen Elena Gómez
Published in: Viruses, Issue 11(2), 2019, Page(s) 160, ISSN 1999-4915
DOI: 10.3390/v11020160

Potent HIV-1-Specific CD8 T Cell Responses Induced in Mice after Priming with a Multiepitopic DNA-TMEP and Boosting with the HIV Vaccine MVA-B

Author(s): Beatriz Perdiguero; Suresh C. Raman; Cristina Sánchez-Corzo; Carlos Oscar S. Sorzano; José Ramón Valverde; Mariano Esteban; Carmen Elena Gómez
Published in: Viruses, Issue 10(8), 2018, Page(s) 424, ISSN 1999-4915
DOI: 10.3390/v10080424