Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza

Keywords

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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0.5mL Intramuscular Injection

0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

Intervention Type BIOLOGICAL

Other Intervention Names

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rHA recombinant hemagglutinin PanBlok

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Manon M.J. Cox

CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Treanor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

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Treanor JJ, Essink B, Hull S, Reed S, Izikson R, Patriarca P, Goldenthal KL, Kohberger R, Dunkle LM. Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant. Vaccine. 2013 Nov 19;31(48):5760-5. doi: 10.1016/j.vaccine.2013.08.064. Epub 2013 Sep 27.

Reference Type DERIVED

PMID: 24075920 (View on PubMed)

Other Identifiers

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PSC22 GLA-SE

Identifier Type: -

Identifier Source: org_study_id

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

PanBlok 135µg No Adjuvant

0.5mL Intramuscular Injection

PanBlok 45µg No Adjuvant

0.5mL Intramuscular Injection

PanBlok 45µg and GLA 1.0µg, SE 2%

0.5mL Intramuscular Injection

PanBlok 15µg and GLA 1.0µg, SE 2%

0.5mL Intramuscular Injection

PanBlok 7.5µg and GLA 1.0µg, SE 2%

0.5mL Intramuscular Injection

PanBlok 3.8µg and GLA 1.0µg, SE 2%

0.5mL Intramuscular Injection

Placebo

0.5mL Intramuscular Injection

Interventions

0.5mL Intramuscular Injection

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Protein Sciences Corporation

Responsible Party

Manon M.J. Cox

Principal Investigators

John Treanor, MD

Locations

Vince and Associates Clinical Research

Meridian Clinical Research

University of Rochester

Benchmark Research

Countries

References

Related Links

Other Identifiers

PSC22 GLA-SE