Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older (PSC26)
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Coastal Clinical Research
- Avail Clinical Research
- Meridian Clinical Research
- Meridian Clinical Research
- Regional Clinical Research, Inc.
- Rapid Medical Research, Inc.
- Benchmark Reseach
- Benchmark Research - Fort Worth
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Panblok 30µg in 2% SE
Panblok 15µg in 2% SE
Panblok 7.5µg in 2% SE
Panblok 30µg (No Adjuvant)
30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle