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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
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.
Details
| Lead sponsor | PX'Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2013-04 |
| Completion | 2014-02 |
Conditions
- - HIV
Interventions
- EN41-UGR7C HIV vaccine
- NaCl
Primary outcomes
- Safety of 3 EN41-UGR7C administrations — Up to 3 months after the last administration
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 — Up to 3 months after the final administration
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.
Countries
United Kingdom