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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05644067 | Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country | PHASE1 | COMPLETED | 40 | — | — | Aug 25, 2023 | Apr 2, 2024 | Apr 15, 2024 | 1 | Tanzania |
Local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 7 days later to evaluate safety and reactogenicity of SumayaVac-1 (SUM-101)
Local and systemic unsolicited reactogenicity recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 28 days later to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Any serious adverse events (SAE) occurring after the 1st vaccination until the participant's last visit to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Changes in laboratory safety parameters as defined in the protocol for every participant between baseline (Day 0 before 1st vaccination) to 28 days after each of the vaccinations to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Changes in laboratory safety parameters as defined in the protocol for every participant between values recorded just prior to each vaccination (on Day 0, Day 28 and Day 56) and values found 28 days after proceeding with vaccination to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Longevity of antibody responses to SumayaVac-1 (SUM-101) by ELISA for all participants at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
Fold change of antibody responses to SumayaVac-1 (SUM-101) by ELISA in comparison to baseline (Day 0 pre-vaccination) for all participants to Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
| Arm | Type | Description |
|---|---|---|
| SumayaVac-1(SUM-101) | EXPERIMENTAL | Candidate malaria Vaccine (Investigational Medicinal Product (IMP)). 20 participants will be randomised to receive three monthly inoculations of the IMP |
| Verorab | PLACEBO_COMPARATOR | Comparator used as a control. 20 participants will be randomised to receive three monthly inoculations of the comparator. |
| Name | Type | Description |
|---|---|---|
| SumayaVac-1(SUM-101) | BIOLOGICAL | One immunization every 4 weeks for 3 months (total 3 immunizations) |
| Verorab | BIOLOGICAL | One immunization every 4 weeks for 3 months (total 3 immunizations) |
Inclusion Criteria: 1. Written informed consent obtained before any study procedure. 2. Literate participants aged 18-45 years of African origin. 3. Female participants practicing contraception from 4 weeks before 1st immunization and both female and male participants willing to practice contracept...
| 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 |