Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. |
A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers |
Humans |
Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN) |
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018. |
Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. |
Humans |
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |
Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015. |
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia |
Humans |
Chimeric antigen receptor against CD19 |
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. |
A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) |
Humans |
Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |
B/BE/09/BVW1 |
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 |
Humans |
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |
B/BE/08/BVW1 |
MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants |
Humans |
Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F). |
B/BE/04/BV1 |
Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats |
cats |
gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV) |
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. |
A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine |
Humans |
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |
B/BE/98/B6 |
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers |
Humans |
wild-type p53 tumor suppressor gene |
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. |
A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles |
Humans |
Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. |
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection |
Humans |
Wild-type p53 |