EAVI2020 – 01

Status:Ongoing
Phase:I
Principal Investigator(s):Katrina Pollock
Objective:An Experimental Medicine Study Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens and the Breadth of the Induced B and T Cell Repertoires.Our research will investigate the effect of a second immunisation challenge with a combination of three model mosaic envelope proteins designed to increase the breadth of induced antibody neutralisation. The primary outcome will be measurement of specific viral neutralisation activity of serum antibodies. Exploratory outcomes will include characterisation of blood B and T cell responses to these model immunogens. Last updated September 16, 2022
Prevention Option(s):Antibody Related Research
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionBiological: ConM SOSIP Recombinant HIV-1 trimeric gp140 Env protein: ConM SOSIP gp140. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle. Biological: Mosaic SOSIPs Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
Mode of DeliveryIntramuscular
ARMsActive Comparator
DescriptionBiological: 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 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle. Biological: Mosaic SOSIPs Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
Mode of DeliveryIntramuscular
ARMsActive Comparator
DescriptionBiological: ConS UFO Recombinant HIV-1 trimeric gp140 Env protein: ConS UFO gp140. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle Biological: Mosaic SOSIPs Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
Mode of DeliveryIntramuscular
ARMsActive Comparator
DescriptionBiological: 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 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle. Biological: Mosaic SOSIPs Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
Mode of DeliveryIntramuscular
ARMsActive Comparator
DescriptionBiological: 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 ug and will be admixed with 500 ug 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 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle Biological: Mosaic SOSIPs Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
Mode of DeliveryIntramuscular
ARMsActive Comparator
Official Code: NCT03816137
Related Publications:
Towards a prophylactic HIV vaccine: fine needle aspiration reveals cellular features of human lymph nodes compared with blood in the EAVI2020_01 study (Abstract P027).
Structure and immunogenicity of a stabilized HIV-1 envelope trimer based on a group-M consensus sequence
EAVI2020 Announces Start of New HIV Vaccine Trial
Trial Sponsors: Imperial College London
Start Date
End Date
March 19, 2019
December 31, 2022
Enrollment:50
Age range: 18 Years ↔ 55 Years
Population:Cisgender Men