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

NCT02464163 | Completed Phase 1 Results DMC

• 1 other identifier: PSC26
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

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.

  42 Days

Secondary Outcomes (3)

• Reactogenicity Immediately After Each Injection, Extending to Day 7

  7 Days

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

  13 months

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

  42 Days

Study Arms (4)

Panblok 30µg in 2% SE

EXPERIMENTAL

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

Panblok 15µg in 2% SE

EXPERIMENTAL

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

Panblok 7.5µg in 2% SE

EXPERIMENTAL

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

Panblok 30µg (No Adjuvant)

EXPERIMENTAL

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

Biological: Panblok

Interventions

Panblok BIOLOGICAL

Intramuscular injection

Also known as: recombinant hemagglutinin, rHA

Panblok 15µg in 2% SE; Panblok 30µg (No Adjuvant); Panblok 30µg in 2% SE; Panblok 7.5µg in 2% SE

rHA adjuvant BIOLOGICAL

Intramuscular injection

Also known as: SE

Panblok 15µg in 2% SE; Panblok 30µg in 2% SE; Panblok 7.5µg in 2% SE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Protein Sciences Corporation: lead

Study Sites (9)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68164, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Benchmark Reseach

Austin, Texas, 78705, United States

Location

Benchmark Research - Fort Worth

Fort Worth, Texas, 76135, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Lisa M. Dunkle, M.D., Chief Medical Officer
• Organization: Protein Sciences Corporation

ldunkle@proteinsciences.com

203-599-6064

Study Officials

• John J Treanor, MD

  University of Rochester Center for Vaccine Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 26, 2017
• Results First Posted: October 26, 2017

Record last verified: 2017-09

Locations

US (9)