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Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years

NCT01676402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2022-08-25

No results posted yet for this study

Summary

This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The hypothesis is that evaluation of these investigational schedules will inform development of novel influenza vaccine strategies that may offer improved and cross-protective immunity against antigenically diverse influenza strains.

Conditions

Interventions

BIOLOGICAL

Seasonal Influenza DNA vaccine

VRC-FLUDNA063-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1); A/Victoria/361/2011 (H3), and B/Wisconsin/2010. DNA vaccine vials will be supplied at 4 mg/mL in single use vials. The 4 mg dosage is administered as a 1 mL volume.

BIOLOGICAL

TIV

2012/13, 2013/14 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Barney S Graham, M.D., Ph.D. · Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIH

  • Julie Ledgerwood, DO · Deputy Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01676402 on ClinicalTrials.gov