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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01857869 | Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults | PHASE2 | COMPLETED | 64 | — | — | May 20, 2013 | Dec 16, 2014 | Jun 26, 2019 | 1 | United States |
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 | 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 |