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CompletedNCT02464163PSC26Updated Oct 26, 2017Results posted

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

A Phase 1/2 interventional study of Panblok and rHA adjuvant in Influenza, sponsored by Protein Sciences Corporation. Completed at 9 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Protein Sciences Corporation · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
407
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.

One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 407 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Protein Sciences Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adults, regardless of gender, aged 18 years and above
  2. Able to give written informed consent to participate.
  3. Body temperature \<100.0ºF.
  4. The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history.
  5. Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
  6. Women are considered not of child-bearing potential if they are:

    • Surgically sterile
    • Menopausal, defined as no natural menses for ≥12 months
  7. Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
  5. 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.
  6. Persons with a history of documented autoimmune disease.
  7. Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.
  8. Persons who have had a prior serious reaction to any influenza vaccine.
  9. Persons with a known history of Guillain-Barré Syndrome (GBS).
  10. Persons with a history of anaphylactic-type reaction to injected vaccines.
  11. Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.
  12. Persons who received a seasonal influenza vaccine \< 6 months prior to enrollment (may delay enrollment).
  13. 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.)
  14. 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).
  15. 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.
  16. 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
407 participants (actual)

Study arms

  • Experimental
    Panblok 30µg in 2% SE

    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

    Biological: Panblok · Biological: rHA adjuvant

  • Experimental
    Panblok 15µg in 2% SE

    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

    Biological: Panblok · Biological: rHA adjuvant

  • Experimental
    Panblok 7.5µg in 2% SE

    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

    Biological: Panblok · Biological: rHA adjuvant

  • Experimental
    Panblok 30µg (No Adjuvant)

    30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle

    Biological: Panblok

Interventions

  • BiologicalPanblok

    Intramuscular injection

    Also known as: recombinant hemagglutinin, rHA

  • BiologicalrHA adjuvant

    Intramuscular injection

    Also known as: SE

06

What researchers measure

Primary outcomes

  1. Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.

    The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.

    Time frame: 42 Days

Secondary outcomes

  1. Reactogenicity Immediately After Each Injection, Extending to Day 7

    Solicited events of local and systemic reactogenicity Days 0-7

    Time frame: 7 Days

  2. Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination

    Time frame: 13 months

  3. Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine

    Unsolicited adverse events (UAEs) Days 0-42.

    Time frame: 42 Days

07

Results

Posted Oct 26, 2017

Participant flow

Participant flow — Overall Study
MilestonePanblok 30µg in 2% SEPanblok 15µg in 2% SEPanblok 7.5µg in 2% SEPanblok 30µg (No Adjuvant)
Started102102102101
Completed99949796
Not completed3855

Outcome measures

PrimaryDemonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.

The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.

Time frame:
42 Days
Reported as:
Count of participants · Participants
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
ParticipantsPanblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.119151
SecondaryReactogenicity Immediately After Each Injection, Extending to Day 7

Solicited events of local and systemic reactogenicity Days 0-7

Time frame:
7 Days
Reported as:
Count of participants · Participants
Reactogenicity Immediately After Each Injection, Extending to Day 7
ParticipantsPanblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)
7 Days After First Vaccination37333327
7 Days After Second Vaccination30302618
SecondaryLong-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time frame:
13 months
Reported as:
Count of participants · Participants
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
ParticipantsPanblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)
Angina unstable0010
Myocardial infarction0001
Sinus bradycardia0010
Chest pain0010
Appendicitis1000
Cellulitis0100
Rib fracture1000
Upper limb fracture0001
Arthralgia1000
Fracture malunion0100
Musculoskeletal pain1000
Osteoarthritis2000
Osteolysis0100
Cervicobrachial syndrome1000
Syncope0010
VIIth nerve paralysis1000
Suicide attempt0100
Peripheral arterial occlusive disease0010
SecondaryUnsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine

Unsolicited adverse events (UAEs) Days 0-42.

Time frame:
42 Days
Reported as:
Count of participants · Participants
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
ParticipantsPanblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)
Cardiac disorders0010
Ear and labyrinth disorders1000
Endocrine disorders0200
Eye disorders0010
Gastrointestinal disorders5224
General disorders4212
Immune system disorders1000
Infections and infestations6640
Injury, poisoning and procedural complications3320
Investigations0200
Metabolism and nutrition disorders1100
Musculoskeletal and connective tissue disorders4251
Neoplasms benign, malignant and unspecified1200
Nervous system disorders3251
Psychiatric disorders0001
Reproductive system and breast disorders0100
Respiratory, thoracic and mediastinal disorders6211
Skin and subcutaneous tissue disorders1021
Vascular disorders0101

Adverse events

Collected over Day 0 to Week 55. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Panblok 7.5µg in 2% SE0/100 (0%)4/100 (4%)0/100 (0%)
Panblok 15µg in 2% SE0/101 (0%)4/101 (4%)0/101 (0%)
Panblok 30µg in 2% SE0/102 (0%)3/102 (2.9%)0/102 (0%)
Panblok 30µg (No Adjuvant)1/97 (1%)2/97 (2.1%)0/97 (0%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventPanblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)
OsteoarthritisMusculoskeletal and connective tissue disorders2/1000/1010/1020/97
Myocardial infarctionCardiac disorders0/1000/1010/1021/97
Upper limb fractureInjury, poisoning and procedural complications0/1000/1010/1021/97
AppendicitisInfections and infestations1/1000/1010/1020/97
Rib fractureInjury, poisoning and procedural complications1/1000/1010/1020/97
ArthralgiaMusculoskeletal and connective tissue disorders1/1000/1010/1020/97
Musculoskeletal painMusculoskeletal and connective tissue disorders1/1000/1010/1020/97
Cervicobrachial syndromeNervous system disorders1/1000/1010/1020/97
VIIth nerve paralysisNervous system disorders1/1000/1010/1020/97
CellulitisInfections and infestations0/1001/1010/1020/97

Baseline characteristics

Modified Per Protocol Population

Age, Customized
Age, Customized(Participants)Panblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)Total
Age, Categorical — <65 Years45454942181
Age, Categorical — >=65 Years50495052201
Sex: Female, Male
Sex: Female, Male(Participants)Panblok 7.5µg in 2% SEPanblok 15µg in 2% SEPanblok 30µg in 2% SEPanblok 30µg (No Adjuvant)Total
Female62545661233
Male33404333149
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Study locations

9 sites
  • Coastal Clinical Research
    Mobile, Alabama 36608, United States
  • Avail Clinical Research
    DeLand, Florida 32720, United States
  • Meridian Clinical Research
    Savannah, Georgia 31406, United States
  • Meridian Clinical Research
    Omaha, Nebraska 68164, United States
  • Regional Clinical Research, Inc.
    Endwell, New York 13760, United States
  • Rapid Medical Research, Inc.
    Cleveland, Ohio 44122, United States
  • Benchmark Reseach
    Austin, Texas 78705, United States
  • Benchmark Research - Fort Worth
    Fort Worth, Texas 76135, United States
  • Jean Brown Research
    Salt Lake City, Utah 84124, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02464163
Lead sponsor
Protein Sciences Corporation
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Jul 2015
Primary completion
Aug 2016
Completion
Aug 2016
Results posted
Oct 26, 2017
Last update
Oct 26, 2017

Study contacts

John J Treanor, MD
principal investigator · University of Rochester Center for Vaccine Studies

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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