NCT00408109

Safety Study of Avian Flu Vaccine

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing VRC-AVIDNA036-00-VP in Influenza A Virus, H5N1 Subtype in 45 participants. Completed in 28 August 2008.

Timeline

4 December 2006

28 August 2008

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	45
Start date	4 December 2006
Estimated completion	28 August 2008
Sites	1 location across United States

Drugs / interventions tested

• VRC-AVIDNA036-00-VP — full drug profile →

Conditions studied

• Influenza A Virus, H5N1 Subtype — all drugs for Influenza A Virus, H5N1 Subtype →
• Influenza A Virus — all drugs for Influenza A Virus →
• Influenzavirus A — all drugs for Influenzavirus A →
• Orthomyxoviridae — all drugs for Orthomyxoviridae →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 60, any sex, with Influenza A Virus, H5N1 Subtype or Influenza A Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine if an experimental avian flu (bird flu) vaccine is safe, whether it has side effects and if it can stimulate an immune response in people. The vaccine being tested in this study is made from DNA (genetic material) that codes for an influenza protein called hemagglutinin 5 (H5), which is based on the protein from the bird flu virus. The study will determine if the body creates resistance or immunity to the H5 protein. The hope is that an immune response to this protein may protect against bird flu virus infection.

Healthy people between 18 and 60 years old who have been vaccinated with the current season's influenza vaccine may be eligible for this study.

Participants are randomly assigned to receive injections of one of the following: 1) study vaccine at 1 mg dose, 2) study vaccine at 4 mg dose, or 3) placebo (salt-water solution). They receive three injections about 4 weeks apart in the upper arm muscle. Participants record their temperature and symptoms at home for 5 days after each injection, either on a diary card or electronically using the Internet, and report any side effects to a study physician or nurse as soon as possible. They return to NIH for clinic visits every 2 weeks for the first 12 weeks, then at week 26 and at week 42 to check for health changes or problems. Blood is drawn at all visits and urine samples are collected through week 10.

If a participant develops serious side effects, the study physician may decide that he or she should not receive any further injections. However, all participants are asked to continue the follow-up visits even if they do not get the full set of three injections.

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Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next-generation influenza vaccines: opportunities and challenges.
   Wei CJ, Crank MC, Shiver J, Graham BS, et al · · 2020 · cited 256× · PMID 32060419 · DOI 10.1038/s41573-019-0056-x
2. Influenza virus h5 DNA vaccination is immunogenic by intramuscular and intradermal routes in humans.
   Ledgerwood JE, Hu Z, Gordon IJ, Yamshchikov G, et al · · 2012 · cited 40× · PMID 22956656 · DOI 10.1128/cvi.05663-11
3. Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases.
   Xu Z, Patel A, Tursi NJ, Zhu X, et al · · 2020 · cited 32× · PMID 35047878 · DOI 10.3389/fmedt.2020.571030
4. The need for novel influenza vaccines in low- and middle-income countries: A narrative review.
   Spinardi JR, Thakkar KB, Welch VL, Jagun O, et al · · 2025 · cited 6× · PMID 39642677 · DOI 10.1016/j.bjid.2024.104465