Comparando dos revisiones:
15 Junio 2021 - 6:53pm por FINLAY | 30 Octubre 2021 - 12:21pm por FINLAY | ||
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< diferencia anterior | próxima diferencia > | ||
Cambios a Authorization date | |||
- | + | 2020-12-17 00:00:00 | |
Cambios a Reference number | |||
- | In process | + | 05.019.20BA |
Cambios a Recruitment status | |||
- | Pending | + | Complete |
Cambios a Data sharing plan | |||
- | No | + | Yes |
Cambios a Description of Data Sharing Plan | |||
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+ | The immunological individual data, and other supporting clinical documents, including study protocol, statistical analysis plan, and the informed consent form will be available after publication in specialized journals. Proposals should be sent to: dagarcia@finlay.edu.cu or: vicente.verez@finlay.edu.cu. These proposals must be reviewed and approved by the sponsor and investigator. Finally, data access agreement must be signed.
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Cambios a Additional information to share | |||
- | + | The Study protocol, statistical analysis plan, and the informed consent form will be available after publication. | |
Cambios a URL for additional information | |||
- | + | https://www.finlay.edu.cu/blog/category/sala-cientifica/ | |
Cambios a Primary outcome(s) | |||
Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
| Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
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Stage IIb:
| Stage IIb:
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- | Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 28, 42 and 56. | + | Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 42, 56, 70, 84. |
Cambios a Key secondary outcomes | |||
1) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose.
| 1) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose.
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2) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose .
| 2) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose .
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- | 3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 28, 42 and 56. 4) Neutralizing antibody titer: Measurement time: Day 0 and 56. 5) % ACE2-RBD inhibition: Measurement time: Day 0, 14, 28, 42 and 56.
| + | 3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 42, 56, 70, 84. 4) Neutralizing antibody titer: Measurement time: Day 0 (only IgG positive), 56, 70, 84 (Sample subset). 5) % ACE2-RBD inhibition: Measurement time: Day 0 (only IgG positive), 14, 42, 56, 70, 84.
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Stage IIb:
| Stage IIb:
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1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
| 1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
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2) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose.
| 2) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose.
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3) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose .
| 3) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose .
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- | 4) Neutralizing antibody titer: Measurement time: Day 0 and 56.
| + | 4) Neutralizing antibody titer: Measurement time: Day 0 (only IgG positive), 56, 70, 84 (sample subset).
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- | 5) % ACE2-RBD inhibition: Measurement time: Day 0, 14, 28, 42 and 56. | + | 5) % ACE2-RBD inhibition: Measurement time: Day 0 (only IgG positive), 14, 42, 56, 70, 84 |
Cambios a Intervention(s) | |||
Stage IIa:
| Stage IIa:
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- | Group 1- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 1) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
| + | Group 1- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 1) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: 25 subjects with FINLAY-FR-2 (Experimental batch 1): high dose of conjugated RBD+adjuvant; 0,5 mL, intramuscular (IM) and 25 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
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- | Group 2- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 2) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
| + | Group 2- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 2) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: 25 subjects with FINLAY-FR-2 (Experimental batch 2): high dose of conjugated RBD+adjuvant; 0,5 mL, intramuscular (IM) and 25 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
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Stage IIb:
| Stage IIb:
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- | Group 1- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 1) + adjuvant; 0.5 mL,by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
| + | Group 1- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 1) + adjuvant; 0.5 mL,by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
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- | Group 2- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 2) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
| + | Group 2- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 2) + adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
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Group 3 Placebo (control): 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. | Group 3 Placebo (control): 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. | ||
Cambios a Record Verification Date | |||
- | 2021/06/15 | + | 2021/10/30 |
Cambios a Next update date | |||
- | 2022/06/15 | + | 2022/10/30 |
Revisión de 30 Octubre 2021 - 12:21pm