drugset / Trial / NCT03816137
Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens
RandomizedSequentialDouble-blindPrevention
Summary
The objective of this experimental medicine study is to determine the extent to which different prime-boost combinations influence serum neutralising antibody breadth and associated B and T cells responses. The investigators hypothesise that the different prime-boost model immunogen combinations will have differential impact on: the magnitude and breadth of induced serum neutralising antibodies; and the induced B- and T-cell responses in peripheral blood. The investigators will investigate this by challenging the immune system of healthy adults with various model immunogens based on HIV-1 Env (ConM and ConS, with and without EDC stabilisation; Mos3.1, Mos3.2 and Mos3.3, and AMC011 and 763 SOSIP) in different prime-boost combinations.
Timeline
- Start
- 2019-03-19
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 763 SOSIP | Unknown | 20 ug | Intramuscular |
| Comparator | 763 SOSIP | Unknown | 50 ug | Intramuscular |
| Comparator | 763 SOSIP | Unknown | 100 ug | Intramuscular |
| Comparator | AMC011 SOSIP | Unknown | 20 ug | Intramuscular |
| Comparator | AMC011 SOSIP | Unknown | 50 ug | Intramuscular |
| Comparator | AMC011 SOSIP | Unknown | 100 ug | Intramuscular |
| Comparator | ConM SOSIP | Protein / enzyme biologic | 20 ug | Intramuscular |
| Comparator | ConM SOSIP | Protein / enzyme biologic | 50 ug | Intramuscular |
| Comparator | ConM SOSIP | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | ConS UFO | Protein / enzyme biologic | 50 ug | Intramuscular |
| Comparator | ConS UFO | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | EDC ConM SOSIP | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | EDC ConS UFO | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | Mos3.1 | Protein / enzyme biologic | 20 ug | Intramuscular |
| Comparator | Mos3.1 | Protein / enzyme biologic | 33 ug | Intramuscular |
| Comparator | Mos3.1 | Protein / enzyme biologic | 50 ug | Intramuscular |
| Comparator | Mos3.1 | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | Mos3.2 | Protein / enzyme biologic | 20 ug | Intramuscular |
| Comparator | Mos3.2 | Protein / enzyme biologic | 33 ug | Intramuscular |
| Comparator | Mos3.2 | Protein / enzyme biologic | 50 ug | Intramuscular |
| Comparator | Mos3.2 | Protein / enzyme biologic | 100 ug | Intramuscular |
| Comparator | Mos3.3 | Protein / enzyme biologic | 20 ug | Intramuscular |
| Comparator | Mos3.3 | Protein / enzyme biologic | 33 ug | Intramuscular |
| Comparator | Mos3.3 | Protein / enzyme biologic | 50 ug | Intramuscular |
| Comparator | Mos3.3 | Protein / enzyme biologic | 100 ug | Intramuscular |