Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03590340 | Regimen Optimization Trial of PfSPZ Vaccine in Equatorial Guinea | PHASE1 | COMPLETED | 104 | — | — | Jul 30, 2018 | Mar 12, 2019 | Jan 7, 2020 | 1 | Equatorial Guinea |
1. Occurrence of solicited local AEs during priming vaccination and a 3-day surveillance period after priming and boost vaccinations. 2. Occurrence of solicited systemic AEs during priming vaccination and a 7-day surveillance period after priming and boost vaccinations. 3. Occurrence of unsolicited AEs during priming vaccination and a 14-day surveillance period after priming and boost vaccinations. 4. Occurrence of serious adverse events (SAEs) during the study.
| Arm | Type | Description |
|---|---|---|
| Group 1a (PfSPZ Vaccine) | EXPERIMENTAL | Group 1a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10\^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10\^5 PfSPZ Vaccine on Day 113. Controlled human malaria infection (CHMI) with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 2a (PfSPZ Vaccine) | EXPERIMENTAL | Group 2a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10\^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last prime dose by DVI injection. |
| Group 3a (PfSPZ Vaccine) | EXPERIMENTAL | Group 3a: subjects (n=21) will receive four doses of PfSPZ Vaccine (9.0 x 10\^5 PfSPZ/dose) on Days 1, 3, 5, and 7 as a prime, followed by a boost of 9.0x10\^5 PfSPZ Vaccine on Day 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 4a (PfSPZ Vaccine) | EXPERIMENTAL | Group 4a: subjects (n=21) will receive two doses of PfSPZ Vaccine (9.0 x 10\^5 PfSPZ/dose) on Days 1 and 8 as a prime, followed by a boost of 9.0x10\^5 PfSPZ Vaccine on Day 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last boost dose by DVI injection. |
| Group 1b (NS) | PLACEBO_COMPARATOR | Group 1b: subjects (n=5) will receive normal saline (NS) placebo on Days 1, 3, 5, 7, and 113. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 2b (NS) | PLACEBO_COMPARATOR | Group 2b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, and 7. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 3b (NS) | PLACEBO_COMPARATOR | Group 3b: subjects (n=5) will receive NS placebo on Days 1, 3, 5, 7, and 29. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Group 4b (NS) | PLACEBO_COMPARATOR | Group 4b: subjects (n=5) will receive NS placebo on Days 1 and 8. CHMI with PfSPZ Challenge (NF54) will be administered 8 weeks after the last immunization by DVI. |
| Name | Type | Description |
|---|---|---|
| PfSPZ Vaccine | BIOLOGICAL | Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine) |
| Normal saline | OTHER | Normal saline is 0.9% sodium chloride |
| PfSPZ Challenge (for CHMI) | BIOLOGICAL | Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54 |
Inclusion Criteria: 1. Healthy males and non-pregnant/non-lactating females, age 18 to 45 years at time of enrollment. 2. Provision of signed and dated informed consent form. 3. Demonstrate understanding of the study by responding correctly to 10 out of 10 true/false statements about the trial (a m...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |