B/BE/21/BVW9 |
Dossier withdrawn by the notifier |
Humans |
V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30) |
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018. |
A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease |
Humans |
Modified cells expressing Hemoglobin F (HbF) |
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014. |
A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects |
Humans |
gene expressing certolizumab |
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012. |
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects |
Humans |
Human Trefoil Factor 1 |
Only notified under the "contained use" procedure. Dossier submitted on 08/07/2010. |
An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. |
Humans |
Gag, Pol, Nef genes of HIV |
B/BE/07/BVW1 |
Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis |
Humans |
Gene coding for the human interleukin-10 (hIL-10) |
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) |
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 |