Table 2 Clinical trial and compassionate use applications for therapeutics, vaccines, and diagnostics
Intervention | Product | Phase/study type | Short title | Regulatory decision |
|---|---|---|---|---|
Therapeutics | Convalescent whole blood (CWB) | 2/3 | Effectiveness of CWB in the treatment of consented EVD patients | No objection |
Convalescent plasma (CP) | 2/3 | Effectiveness of CP in the treatment of consented EVD patients | No objection | |
ZMapp® | 2/3 | Safety and efficacy of ZMapp | No objection | |
TKM-130803 | 2/3 | Safety and efficacy of TKM 130803 | No objection | |
Brincidofovir | 2 | Safety and efficacy of brincidofovir | CTA withdrew by the sponsor | |
FX-06 | Compassionate use | Compassionate use of FX-06 | No objection | |
ZMapp® | Compassionate use | Expanded access programme for ZMapp | No objection | |
Vaccines | rVSV-ZEBOV-GP | 2/3 | Safety and immunogenicity of rVSV-ZEBOV-GP | No objection |
Ad26.ZEBOV/MVA-BN-Filo | 2/3 | Safety and immunogenicity of Ad26.ZEBOV/MVA-BN-Filo | No objection | |
Ad5-EBOV | 2 | Safety and immunogenicity of Ad5-EBOV | No objection | |
Ad26.ZEBOV/MVA-BN-Filo/rVSV-ZEBOV-GP | 2 | Safety and immunogenicity of the three vaccines | No objection | |
Ad26.ZEBOV/MVA-BN-Filo | 2 | Long-term safety and immunogenicity of Ad26.ZEBOV/MVA-BN-Filo | No objection | |
Ad26.ZEBOV/MVA-BN-Filo | 2 | Safety and immunogenicity in infants 4-11 months | No objection | |
Ad26.ZEBOV | 2 | Safety and immunogenicity in children previously vaccinated with the two doses of Ad26.ZEBOV/ MVA-BN-Filo | No objection | |
rVSV-ZEBOV-GP | Compassionate use | Ring vaccination compassionate use of rVSV-ZEBOV-GP | No objection | |
Ad26.ZEBOV/MVA-BN-Filo | Compassionate use | Deployment and effectiveness of Ad26.ZEBOV/MVA-BN-Filo | No objection | |
Rapid diagnostic tests | Zalgen recombinant RDT | Validation | Evaluation of the performance of Zalgen | No objection |
Biocartis RDT | Validation | Evaluation of the performance of Biocartis | Objection | |
Cepheid RDT | Validation | A validation study of the performance of Cepheid RDT | No objection | |
Micro BB RDT | Validation | Evaluation of the performance Micro BB RDT | No objection | |
BSL-2 Assay RDT | Validation | Evaluation of the performance of BSL-2 assay RDT | No objection |