Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

Completed · Phase 1/Phase 2

Conditions studied: Influenza

In brief

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.

Key facts

Study ID

NCT01612000

Run by

Protein Sciences Corporation

People needed

341

Starts

2012-05-01

Expected to finish

2013-12-01

Last updated by the study team

2015-11-25

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Young adults aged 18-49 years
• Able to give written informed consent to participate.
• Vital signs within normal limits.
• The subject must be in good health as determined by targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc., or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.
• Comprehensive Metabolic Panel and other tests for the following must fall within normal limits or not exceed a Grade 1 abnormality at screening. Any Grade 1 abnormality must be clinically acceptable to the investigator in the context of other parameters such the subject's medical history. However, this will not apply to an above the upper limit of the normal range for ALT. Subjects with values above the upper limit of the normal range for ALT at the screening visit will not be enrolled.
• Complete Blood Count with Cell Differential and urinalysis must fall within normal limits at screening except when clinically acceptable to the investigator in the context of other parameters such the subject's medical history.
• Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
• WOCBP must use medically acceptable contraception.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

You may not qualify if…

• Previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
• An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses
• Medications or treatments that may adversely affect the immune system
• An active neoplastic disease or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
• A long-term use of supraphysiologic doses of oral or parenteral steroids, or high-dose inhaled steroids within the preceding 6 months.
• A history of documented autoimmune disease.
• Pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization
• Prior serious reaction to any influenza vaccine
• History of Guillain-Barré Syndrome
• History of anaphylactic-type reaction to injected vaccines
• History of illicit drug use or alcohol abuse in the year preceding the study
• Received a seasonal influenza vaccine six months prior to enrollment
• Received any licensed inactivated or recombinant vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment.
• Acute illness or fever within three days prior to study enrollment
• Participating in a study that involves an experimental agent or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
• Received or expect to receive immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
• An elevated liver function enzyme of ALT at baseline, regardless of the appraisal of clinical significance.

Where it is running

• Meridian Clinical Research — Omaha, Nebraska, United States
• University of Rochester Center for Vaccine Studies — Rochester, New York, United States
• Benchmark Reseach — Austin, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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