CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
VRC-AVIDNA036-00-VP +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01086657
NCT01086657Phase 1Completed

VRC 310: An Open-Label, Randomized Ph I: Healthy Adults of Prime-Boost Intervals w/Monovalent Influenza Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant H5 DNA Vaccine

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 15, 2010·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating VRC-AVIDNA036-00-VP and Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccine for Influenza A Virus, H5N1 Subtype. Completed, enrolled 64 participants across 1 site.

Detailed Summary

Background: \- New vaccines against avian influenza, also known as "bird flu," are being developed and require testing to determine if they are safe and effective and whether they have any side effects. Researchers are interested in testing two experimental avian influenza vaccines to see whether they are safe, if there are any side effects from the vaccines, and how the body's immune response differs in response to different vaccination schedules. One vaccine is an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that allows the body to use vaccine to make an immune system response to a specific part of an avian influenza protein. Objectives: * To determine the safety and potential side effects of two experimental vaccines against avian influenza. * To evaluate whether the time between the two experimental vaccine injections affects the immune response to the vaccine. Eligibility: \- Healthy individuals between 18 and 60 years of age. Design: * Participants will be randomly divided (by chance) into six groups to receive two injections of vaccine at different intervals. One group will receive only the inactivated vaccine, while the other groups will receive the DNA vaccine followed by the inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks or 24 weeks later). * Participants will remain at the clinical center for at least 30 minutes after each vaccination. A few days after each injection, participants will contact staff by telephone or have a clinic visit. Participants will also be asked to complete a diary card at home for 5 days to keep track of temperature changes, injection site skin changes, and other effects. * Four weeks after the first injection, participants will return for a clinic visit and to provide blood samples for testing. * Two weeks after the second injection, participants will return for a clinic visit and provide blood samples (collected through apheresis) to provide information on immune response to the vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2010
Enrollment StartFeb 25, 2010
Primary CompletionDec 12, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

VRC-AVIDNA036-00-VPbiological

H5 DNA Vaccine

Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccinebiological

Inactive H5N1 Vaccine