CompletedPhase 1

An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...

United States64 participantsStarted 2010-02-25

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: A subject must meet all of the following criteria: 18 to 60 years old. Available for clinical follow-up for up to 32 weeks after enrollment. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. Complete an Assessment of Understanding (AoU) questionnaire 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. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \< 40 within the 56 days prior to enrollment. Laboratory Criteria within 56 days prior to enrollment: Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to13.5 g/dL for men White blood cells (WBC) = 3,300-12,000 cells/mm(3) Differential either within institutional normal range or accompanied by site physician approval Total lymphocyte count greater than or equal to 800 cells/mm3 Platelets = 125,000 - 500,000/mm(3) Alanine aminotransferase (ALT) \< 1.25 x upper limit of normal (ULN) Serum creatinine less than or equal to 1 x ULN (less than or equal to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males) Negative FDA-approved HIV blood test. \[Note: Results of HIV enzyme-linked immunosorbent assay…

What they're measuring

Safety: adverse events, including clinical, laboratory and local and systemic reactogenicity

Trial details

NCT IDNCT01086657

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-12-12