Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PfSPZ Vaccine · 1 trial · 1 indication
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 | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
PfSPZ Vaccine is an investigational vaccine being studied for the prevention of malaria. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is being evaluated in healthy adult volunteers to assess its safety and immunogenicity.
PfSPZ Vaccine is being developed by Atlantic International Corp., a company listed on the stock exchange under the ticker ATLN. The company is conducting clinical research to evaluate the vaccine's potential for preventing malaria.
PfSPZ Vaccine is currently in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 1 trial has been completed, and the vaccine remains under evaluation for its safety and efficacy in preventing malaria.
PfSPZ Vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT03590340. This trial was a randomized, double-blind, placebo-controlled study conducted in Equatorial Guinea, enrolling 104 healthy adult volunteers aged 18 years and older to evaluate the vaccine for malaria prevention.
PfSPZ Vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine for malaria prevention. It is currently in Phase 1 clinical trials and is not yet approved for use. The vaccine is being studied for its ability to protect against malaria infection.