個案報告表(Case Report Forms, CRF) 提供給受試者的資料(Subject-facing materials) 計畫主持人同意書(Investigator Agreement) FDA1572 (IND site適用)或ISI (Non-IND site適用) 財務揭露表(Financial Disclosure Form, FDF) 試驗協議:臨床試驗合約(Clinical Trial Agreement, CTA)、保密協議(Confidential Disclosure...
The macaque model has convincingly demonstrated the pre-clinical potential of the ALVAC/simian immunodeficiency virus (SIV) vaccine modality boosted with gp120 (ref.13) by reproducing the efficacy of the successful RV144 HIV vaccine trial testing the alum adjuvant8and predicting the failure of the ...
Rasmussen, T. A. et al. Panobinostat, a histone deacetylase inhibitor, for latent-virus reactivation in HIV-infected patients on suppressive antiretroviral therapy: a phase 1/2, single group, clinical trial.Lancet HIV1, e13–e21 (2014). ...
In parentheses we report the percentages of animals with positive responses. 3.2. SIV-specific T cell immune responses in peripheral blood and tissues A single oral immunization with mc26435 was sufficient to induce SIV Gag-specific T cell responses by 3 weeks of age (Fig. 2A), prior to MVA...
These data are consistent with the report that very low serum concentration of an antibody-like molecule, in this case, a CD4-IgG2 construct, may be sufficient for macaque protection.40 Anti-CD8 treatment resulted in transient viral rebound in the 2 animals reaching peak viremia between 28,000...
are characterized by a lack of gut microbial translocation and robust secondary lymphoid natural killer cell responses resulting in an absence of chronic inflammation and limited SIV dissemination in lymph node B-cell follicles. Here we report, using the pathogenic model of antiretroviral therapy-treated...
Following some high-profile clinical trial failures in recent years, the emphasis in HIV/AIDS vaccine research has shifted away from T-cell-based vaccines that control viral replication towards vaccines that block acquisition of infection. Hansen et al.
Details of animal welfare and steps taken to ameliorate suffering were in accordance with the recommendations of the Weatherall report, “The use of non-human primates in research”. Animals were housed in an air-conditioned facility with an ambient temperature of 21–25 °C, a relative humidity...
However, no successful phase II clinical trial targeting Tat has so far been reported [9]. This might be due to the variability of Tat variants, as Tat can tolerate up to 38% sequence variation that...
a hot spot of damage during acute HIV and SIV infection. An analogous human antibody called vedolizumab was FDA-approved for the treatment of Crohn's disease and ulcerative colitis in 2014. Based on the current findings, a pilot clinical trial, testing the safety of vedolizumab and its effect...