MedTrace Logo

EuroNeut41: Safety & Immunogenicity of Immunisations With HIV Vaccine

NCT01509144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-05-21

No results posted yet for this study

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

Interventions

BIOLOGICAL

EN41-FPA2 HIV vaccine

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

BIOLOGICAL

EN41-FPA2 HIV vaccine

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

BIOLOGICAL

EN41-FPA2 HIV vaccine

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

BIOLOGICAL

EN41-FPA2 HIV vaccine

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

BIOLOGICAL

Na Cl Placebo vaccine

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

Sponsors & Collaborators

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
2012-01-31
Primary Completion
2013-06-30
Completion
2013-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT01509144 on ClinicalTrials.gov