Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older

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/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.

Key facts

Study ID

NCT02464163

Run by

Protein Sciences Corporation

People needed

407

Starts

2015-07-01

Expected to finish

2016-08-01

Last updated by the study team

2017-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults, regardless of gender, aged 18 years and above
• Able to give written informed consent to participate.
• Body temperature <100.0ºF.
• The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on 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.
• Women are considered not of child-bearing potential if they are:
• Surgically sterile
• Menopausal, defined as no natural menses for ≥12 months
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.

You may not qualify if…

• Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.
• Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.
• Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.
• Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
• Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
• Persons with a history of documented autoimmune disease.
• Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.
• Persons who have had a prior serious reaction to any influenza vaccine.
• Persons with a known history of Guillain-Barré Syndrome (GBS).
• Persons with a history of anaphylactic-type reaction to injected vaccines.
• Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.
• Persons who received a seasonal influenza vaccine < 6 months prior to enrollment (may delay enrollment).
• Persons who received any licensed inactivated or recombinant (non-live) vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment (may delay enrollment) (See separate exclusion criteria #1 and #12 for seasonal and H5N1 influenza vaccines.)
• Persons who have had an acute illness or fever (>38º C or >100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).
• Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) 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.
• Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.

Where it is running

• Coastal Clinical Research — Mobile, Alabama, United States
• Avail Clinical Research — DeLand, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Regional Clinical Research, Inc. — Endwell, New York, United States
• Rapid Medical Research, Inc. — Cleveland, Ohio, United States
• Benchmark Reseach — Austin, Texas, United States
• Benchmark Research - Fort Worth — Fort Worth, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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