Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase 1 Randomised, Single-centre, Observer-blind, Placebo-controlled Trial of Safety and Immunogenicity of EN41-UGR7C HIV Vaccine Candidate Administered Intramuscularly in Healthy Female Volunteers|
- Safety of 3 EN41-UGR7C administrations [ Time Frame: Up to 3 months after the last administration ] [ Designated as safety issue: Yes ]1. Safety assessed at any time from the first dose until 3 months after last administration by:Proportion of subjects developing Grade 3 or 4 adverse event
- Assessment of EN41-UGR7C immunogenicity [ Time Frame: Up to 3 months after the final administration ] [ Designated as safety issue: No ]
Immunogenicity: to assess the EN41-UGR7C specific serum IgG responses measured by ELISA induced by the vaccine candidate up to 3 months after the final administration with a 3-fold increase from pre-administration baseline sample taken at visit 2, week 0.
If no serum sample is available from this time point, serum taken at visit 1, screening, may be substituted.
- EN41-UGR7C specific ELISA IgA responses [ Time Frame: Up to 3 months after the final administration ] [ Designated as safety issue: No ]-To measure the EN41-UGR7C specific ELISA IgA responses in serum and EN41-UGR7C IgA and IgG responses in vaginal samples up to 3 months after the final administration
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: EN41-UGR7C HIV vaccine
Group 1: IM injection of 210 µg UGR7-C in 560 µg of Alum at month 0, 1 and 4
Biological: EN41-UGR7C HIV vaccine
Other Name: EN41-UGR7C adjuvanted with Alum
Placebo Comparator: NaCl
Group 2: IM injection of 700 µL of 0.9% sodium chloride (NaCl) at month 0, 1 and 4
Other Name: NaCl placebo vaccine
|Contact: Margaret Johnson, Pr||+44 (0)20 7 830 email@example.com|
|Contact: Sabine Kinloch, Dr||+44 (0)20 7830 firstname.lastname@example.org|
|Royal Free Hospital; Royal Free London NHS Foundation Trust Pond Street||Not yet recruiting|
|London, United Kingdom, NW3 2QG|
|Principal Investigator: Margaret Johnson, Pr|
|Sub-Investigator: Sabine Kinloch, Dr|
|Principal Investigator:||Margaret Johnson, Pr||Royal Free Hospital NHS Foundation Trust|