Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

NCT01827397 | Completed Phase 1 DMC

• 1 other identifier: EN41CT1.1.2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Safety of this HIV vaccine

Outcome Measures

Primary Outcomes (2)

• Safety of 3 EN41-UGR7C administrations

  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

  Up to 3 months after the last administration

• Assessment of EN41-UGR7C immunogenicity

  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.

  Up to 3 months after the final administration

Secondary Outcomes (1)

• EN41-UGR7C specific ELISA IgA responses

  Up to 3 months after the final administration

Study Arms (2)

EN41-UGR7C HIV vaccine

EXPERIMENTAL

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

NaCl

PLACEBO COMPARATOR

Group 2: IM injection of 700 µL of 0.9% sodium chloride (NaCl) at month 0, 1 and 4

Biological: NaCl

Interventions

EN41-UGR7C HIV vaccine BIOLOGICAL

Also known as: EN41-UGR7C adjuvanted with Alum

EN41-UGR7C HIV vaccine

NaCl BIOLOGICAL

Also known as: NaCl placebo vaccine

NaCl

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 55 years on the day of screening
• Available for a maximal study duration of 8 months from screening
• Willing and able to give written informed consent
• At low risk of HIV infection and willing to remain so for the duration of the study defined as:
• no history of injecting drug use in the previous ten years
• no gonorrhoea or syphilis in the last six months
• no high risk partner (e.g. injecting drug use, HIV infected sexual partner) either currently or within the past six months
• no unprotected vaginal or anal intercourse in the last six months outside a relationship with a regular partner known to be HIV negative
• no unprotected sex with someone from a high HIV prevalence region where HIV is more common than in the UK (e.g. Sub-Saharan Africa, Caribbean, South-East Asia)
• Negative HIV1/2 antibody/antigen test result at screening
• If heterosexually active female, using an effective method of contraception using a double barrier method of contraception (combined oral contraceptive pill, injectable or implanted contraceptive and use of condoms incorporating spermicide; physiological or anatomical sterility) from 14 days prior to the first vaccine administration until 3 months after the last administration, and willing to undergo urine pregnancy tests prior to each vaccine administration and blood pregnancy test at screening and final follow-up visits. Heterosexual females who become sexually active during the trial should also follow the same guidance
• Agree to abstain from donating blood during their participation in the trial
• Registered with a General Practitioner and medical history available for 12 months before dosing
• Satisfactory response received from General Practitioner relating to medical history before randomization

You may not qualify if:

• Pregnant or lactating or planning to get pregnant within the next year
• Clinically relevant abnormality on history or examination:
• central nervous system disorder or disease, including history of grand-mal epilepsy
• severe eczema
• clinically significant haematological, cardio-pulmonary, metabolic, gastrointestinal, renal, psychiatric or ophthalmological disorders
• acute infection or illness
• autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
• Known hypersensitivity to any component of the vaccine formulation used in this trial, or have severe or multiple allergies
• History of severe local or general reaction to previous vaccination defined as:
• local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
• general: fever \>39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
• Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of schedules study vaccine dosing
• Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
• Receipt of blood products or immunoglobulin within 4 months of screening
• Participation in another trial of a medicinal product, completed less than 90 days prior to Visit 2 and planned participation in another clinical trial during the present trial

Sponsors & Collaborators

• PX'Therapeutics: lead
• European Commission: collaborator

Study Sites (1)

Royal Free Hospital; Royal Free London NHS Foundation Trust Pond Street

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Interventions

aluminum sulfate

Study Officials

• Margaret Johnson, Pr

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

GB (1)