Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults (PSC25)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01612000
First received: May 7, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: PanBlok
Biological: rHA adjuvant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Observer-Blind, Randomized Trial to Evaluate the Immunogenicity and Safety of PanBlok at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With PanBlok Without Adjuvant in Healthy Adults Aged 18 to 49 Years

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • The difference in immunogenicity between rHA formulated in an oil-in- water adjuvant (SE) compared to a rHA antigen alone. [ Time Frame: 42 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of each study vaccine formulation immediately after each injection, extending to Day 42. [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]
  • Long-term safety as determined by SAEs, New Onset of Chronic Illnesses (NOCIs) or Adverse Events of Special Interest (AESI) during the period of time extending to one year following the final immunization. [ Time Frame: 13 Months ] [ Designated as safety issue: Yes ]

Enrollment: 341
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Intramuscular injection
Other Names:
  • rHA
  • recombinant hemagglutinin
Biological: rHA adjuvant
Intramuscular injection
Other Name: SE
Experimental: PanBlok 3.8µg in 2% SE
3.8µg 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
Intramuscular injection
Other Names:
  • rHA
  • recombinant hemagglutinin
Biological: rHA adjuvant
Intramuscular injection
Other Name: SE
Experimental: PanBlok 7.5µg No Adjuvant
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Biological: PanBlok
Intramuscular injection
Other Names:
  • rHA
  • recombinant hemagglutinin
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
Intramuscular injection
Other Names:
  • rHA
  • recombinant hemagglutinin
Biological: rHA adjuvant
Intramuscular injection
Other Name: SE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612000

Locations
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
University of Rochester Center for Vaccine Studies
Rochester, New York, United States, 14627
United States, Texas
Benchmark Reseach
Austin, Texas, United States, 78705
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: John J Treanor, MD University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT01612000     History of Changes
Other Study ID Numbers: PSC25
Study First Received: May 7, 2012
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014