CompletedPhase 1

Vaccine for Prevention of Bird Flu

United States60 participantsStarted 2008-10-16

Plain-language summary

Study Design: This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens. Product Description: The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine. Subjects: A total of 60 healthy adults, ages 18-60 years will be enrolled. Study Plan: Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 18 to 60 years old.
✓. Available for clinical follow-up through Week 48.
✓. If enrolling from study opening (November 2008) through June 30, 2009, immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval \[14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist (Registered Trademark))\]; subjects enrolling after July 1, 2009 are not required to have prior vaccination with the most recent seasonal influenza vaccine.
✓. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
✓. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
✓. Able and willing to complete the informed consent process.
✓. Willing to donate blood for sample storage to be used for future research.
✓. In good general health without clinically significant medical history.

Exclusion criteria

What they're measuring

Safety (local and systemic reactogenicity, lab tests, AEs)

Trial details

NCT IDNCT00776711

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-01-14

View on ClinicalTrials.gov More Influenza, Human trials