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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04862416 | Safety and Efficacy of R0.6C Vaccine | PHASE1 | COMPLETED | 32 | — | — | May 17, 2021 | Jun 29, 2022 | Mar 5, 2025 | 1 | Netherlands |
The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
The functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
| Arm | Type | Description |
|---|---|---|
| 1A 30μg R0.6C Alhydrogel | EXPERIMENTAL | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 1B 30μg R0.6C Alhydrogel + Matrix M1 | EXPERIMENTAL | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 2A 30μg R0.6C Alhydrogel | EXPERIMENTAL | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 2B 30μg R0.6C Alhydrogel + Matrix M1 | EXPERIMENTAL | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 3A 100μg R0.6C Alhydrogel | EXPERIMENTAL | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 3B 100μg R0.6C Alhydrogel + Matrix M1 | EXPERIMENTAL | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 4A 100μg R0.6C Alhydrogel | EXPERIMENTAL | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 4B 100μg R0.6C Alhydrogel + Matrix M1 | EXPERIMENTAL | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| Name | Type | Description |
|---|---|---|
| R0.6C transmission blocking vaccine | BIOLOGICAL | Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
Inclusion Criteria: 1. Subject must sign written informed consent to participate in the trial. 2. Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health. 3. Subject is able to understand planned study procedures and demonstrate comprehension of the pro...
| 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 |