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

PHASE1CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
HIV-1-infection
Interventions
BIOLOGICAL

ConM SOSIP

Recombinant HIV-1 trimeric gp140 Env protein: ConM SOSIP gp140. Model immunogens will be used at the dosage of 20 mcg or 50 mcg or 100 mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

BIOLOGICAL

EDC ConM SOSIP

Chemically fixed version of recombinant HIV-1 trimeric gp140 Env: EDC ConM SOSIP. Model immunogens will be used at the dosage of 100 mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

BIOLOGICAL

ConS UFO

Recombinant HIV-1 trimeric gp140 Env protein: ConS UFO gp140. Model immunogens will be used at the dosage of 50 mcg or 100 mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle

BIOLOGICAL

EDC ConS UFO

Chemically fixed version of recombinant HIV-1 trimeric gp140 Env : EDC-ConS UFO. Model immunogens will be used at the dosage of 100 mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

BIOLOGICAL

Mosaic SOSIPs

Mosaic gp140 Env trimers (Mos3.1, Mos3.2, Mos3.3) designed to overcome the immunodominance of hypervariable regions of Env. The immunogen will be used at the dosage of 100 mcg (100mcg or 2 x 50 mcg or 3 x 33 mcg) or at 40 mcg (2 x 20mcg) and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

BIOLOGICAL

763 SOSIP

HIV-1 envelope sequence, identified from two HIV infected individuals that displayed HIV neutralisation breadth early in infection (less than 12 months). The immunogen will be used at the dosage of 20 mcg or 50mcg or 100mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

BIOLOGICAL

AMC011 SOSIP

HIV-1 envelope sequence, identified from two HIV infected individuals that displayed HIV neutralisation breadth early in infection (less than 12 months). The immunogen will be used at the dosage of 20 mcg or 50mcg or 100mcg and will be admixed with 500 mcg MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.

Trial Locations (1)

W12 0HS

NIHR Imperial Clinical Resarch Facility, London

All Listed Sponsors
lead

Imperial College London

OTHER

NCT03816137 - Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens | Biotech Hunter | Biotech Hunter