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GSK257049 Dosage 1 · 1 trial · 1 indication
The definition of malaria for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.
| Arm | Type | Description |
|---|---|---|
| GSK257049-0,1,7M Group | EXPERIMENTAL | Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by another dose of GSK257049 vaccine. |
| GSK257049-0,1,2M Group | EXPERIMENTAL | Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months). |
| Infectivity Control Group | EXPERIMENTAL | Volunteers who did not receive any immunization but underwent sporozoite challenge |
| Name | Type | Description |
|---|---|---|
| GSK257049 Dosage 1 | BIOLOGICAL | RTS,S/AS01B administered as 0.5 mL dose at 0 and 1 months and 0.1 mL dose at 7 months for 0,1,7 M Group (delayed fractional dose group). In subjects unprotected in the first challenge, to receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. In subjects protected in the first challenge, randomization to receive or not receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. |
| GSK257049 Dosage 2 | BIOLOGICAL | RTS,S/AS01B administered as three doses of 0.5mL given one month apart (0, 1, 2 M group) in the challenge model. In subjects unprotected in the first challenge, to receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. In subjects protected in the first challenge, randomization to receive or not receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. |
| Sporozoite-infected mosquitoes challenge | PROCEDURE | Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the volunteers. For each volunteer, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. The challenge is scheduled to occur approximately 21 days (3 weeks) after the last vaccination visit (Study Day 196). Volunteers who reconsent for the boost/rechallenge phase will be rechallenged with sporozoite-infected mosquitoes, scheduled to occur approximately 21 days (3 weeks) after the booster dose (Booster Phase Study Day 21). |
Inclusion Criteria: Inclusion criteria for enrolment to the primary phase: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or non-pregnant female 18 to 50 years of age at the time of first vaccination. * Written informed conse...
| 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 |
GSK257049 Dosage 1 is an investigational monoclonal antibody being developed for the prevention of malaria. It is being studied in healthy, malaria-naive adults using a sporozoite challenge model to evaluate its efficacy, safety, and immunogenicity. The drug is currently in Phase 2 clinical development.
GSK257049 Dosage 1 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate this monoclonal antibody candidate for malaria prevention.
GSK257049 Dosage 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under clinical investigation for the prevention of malaria.
GSK257049 Dosage 1 has been studied in one completed Phase 2 clinical trial, registered as NCT01857869. This trial evaluated the efficacy, safety, and immunogenicity of the candidate malaria vaccine in healthy malaria-naive adults using a sporozoite challenge model. The study enrolled 64 participants in the United States.
GSK257049 Dosage 1 is a specific dosage form of the investigational malaria vaccine candidate GSK257049. The clinical trial NCT01857869 evaluates GSK257049 in a defined dosage regimen. GSK257049 is a monoclonal antibody being developed by GSK plc for the prevention of malaria.