EuroNeut41: Safety & Immunogenicity of Immunisations With HIV Vaccine

NCT01509144 | Completed Phase 1 DMC

• 1 other identifier: 2010-023693-39
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

• To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route
• To assess immunogenicity responses induced by the vaccine.

Conditions

HIV

Keywords

Safety of this HIV vaccine

Outcome Measures

Primary Outcomes (1)

• • Safety of 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2

  •Safety - Grade 3 or above adverse event. Any grade of adverse event that results in a clinical decision to discontinue further immunisations - Any grade of adverse event that occurs in a volunteer that has received at least one immunisation • Immunogenicity: Proportion of individuals mounting a serum IgG response to EN41-FPA2 at any time point up to 28 days after the final immunisation with 3 fold increase from pre-immunisation baseline sample taken at visit 2, week 0, priming #1. If no serum sample is available at this time point, serum taken at visit 1, screening may be substituted."

  up to 28 days after the final immunisation

Study Arms (5)

nasal active low dose + IM active

ACTIVE COMPARATOR

Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL)

Biological: EN41-FPA2 HIV vaccine

nasal active mid dose + IM active

ACTIVE COMPARATOR

Group 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL)

Biological: EN41-FPA2 HIV vaccine

nasal active full dose + IM active

ACTIVE COMPARATOR

Group 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL)

Biological: EN41-FPA2 HIV vaccine

nasal placebo + IM active

ACTIVE COMPARATOR

Group 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL)

Biological: EN41-FPA2 HIV vaccine

nasal placebo + IM placebo

PLACEBO COMPARATOR

Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)

Biological: Na Cl Placebo vaccine

Interventions

EN41-FPA2 HIV vaccine BIOLOGICAL

Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL)

nasal active low dose + IM active

Na Cl Placebo vaccine BIOLOGICAL

Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)

nasal placebo + IM placebo

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
• 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 positive partner) either currently or within the past six months
• no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
• no unprotected vaginal intercourse in the last six months outside a relationship with a regular known HIV negative partner
• not had unprotected sex with someone from a region where HIV is more common (e.g Sub-Saharan African, Caribbean, South East Asia) outside a relationship with a regular known HIV negative partner
• Negative HIV 1/2 antibody/antigen test at screening
• If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; use of condoms incorporating spermicide if using these; physiological or anatomical sterility) from 14 days prior to the first vaccination until 6 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination and blood pregnancy test at screening and final follow up.
• Agree, to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal vaccine dosing through to the safety assessment 1week later
• Agree to abstain from donating blood during their participation in the trial
• Registered with GP 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
• Positive alcohol test
• Positive drugs of abuse test
• Clinically relevant abnormality on history or examination:
• central nervous system disorder or disease, including
• history of grand-mal epilepsy
• cranial nerve palsies
• severe eczema
• severe epistaxis requiring surgical intervention or blood transfusion
• clinically significant liver disease
• clinically significant haematological, metabolic, gastrointestinal, renal, psychiatric or cardio-pulmonary disorders
• ongoing infection;
• autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
• using inhaled cortico-steroids and intranasal medications
• Known or suspected history of clinically relevant nasal surgery, injury, nasal polyps or cleft palate, or a condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with intranasal vaccine administration

Sponsors & Collaborators

• PX'Therapeutics: lead
• European Commission: collaborator

Study Sites (1)

Surrey Clinical Research Centre University of Surrey

Guildford, Surrey, GU2 7XP, United Kingdom

Location

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: January 4, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

GB (1)