drugset / Trial / NCT03816137

Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens

NCT03816137 ↗

Phase 1 Completed 117 enrolled Imperial College London
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

EvaluationDrugModalityDoseRoute
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