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Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

NCT01827397 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-05-21

No results posted yet for this study

Summary

The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the virus on the mucosal surface and neutralise the viral particles that may eventually succeed in crossing the mucosal barrier.

This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in humans.

Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but its ability to induce meaningful protection against HIV will not be known before Phase 3 efficacy trials are completed, as correlates of protection against HIV are not yet clearly defined.

Consequently, there is no direct benefit to volunteers. They will be reimbursed for their time and travel.

Conditions

  • - HIV

Interventions

BIOLOGICAL

EN41-UGR7C HIV vaccine

BIOLOGICAL

NaCl

Sponsors & Collaborators

Principal Investigators

  • Margaret Johnson, Pr · Royal Free Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT01827397 on ClinicalTrials.gov