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

NCT03816137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Katrina Pollock · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816137 on ClinicalTrials.gov