Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manon M.J. Cox, Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01147068
First received: June 16, 2010
Last updated: October 24, 2012
Last verified: October 2012
  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 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.


Condition Intervention Phase
Influenza
Biological: 0.5mL Intramuscular Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age. [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]
    Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.


Secondary Outcome Measures:
  • Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age. [ Time Frame: Day 0, and Day 42 ] [ Designated as safety issue: No ]
    Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.

  • Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults


Enrollment: 392
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PanBlok 135µg No Adjuvant
135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Experimental: PanBlok 45µg No Adjuvant
45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Experimental: PanBlok 45µg and GLA 1.0µg, SE 2%
45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Experimental: PanBlok 15µg and GLA 1.0µg, SE 2%
15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Experimental: PanBlok 7.5µg and GLA 1.0µg, SE 2%
7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Experimental: PanBlok 3.8µg and GLA 1.0µg, SE 2%
3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok
Placebo Comparator: Placebo
0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
Biological: 0.5mL Intramuscular Injection
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
  • rHA
  • recombinant hemagglutinin
  • PanBlok

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:

  • Male or female aged 18-49 years.
  • Give written informed consent to participate.
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory evaluation
  • Females should fulfill one of the following criteria:

    • At least one year post-menopausal;
    • Surgically sterile;
    • Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after the booster vaccination; or
    • Willing to use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination and until 28 days after the booster vaccination.
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of first and booster vaccinations
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Exclusion Criteria:

  • Persons under 18 years old or 50 years or older
  • Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease
  • Persons taking medications or treatments that may adversely affect the immune system
  • Persons with known allergy to eggs or other vaccine or adjuvant components
  • Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination
  • Persons who have had a prior serious reaction to any influenza vaccine
  • Persons with a known history of Guillain-Barré Syndrome
  • Persons with a history of anaphylactic-type reaction to injected vaccines
  • Persons with a history of drug or chemical abuse in the year preceding the study
  • Persons who previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
  • Persons who received a seasonal influenza vaccine six months prior to enrollment (may delay enrollment)
  • Persons who received any other vaccine within one week prior to enrollment (may delay enrollment)
  • Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment)
  • Persons currently participating in another research study involving any study medications (investigational drugs or vaccines).
  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: NCT01147068

Locations
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66210
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Benchmark Research
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: John Treanor, MD University of Rochester
  More Information

Additional Information:
No publications provided by Protein Sciences Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manon M.J. Cox, CEO, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT01147068     History of Changes
Other Study ID Numbers: PSC22 GLA-SE
Study First Received: June 16, 2010
Results First Received: October 24, 2012
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

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

ClinicalTrials.gov processed this record on October 23, 2014