Clinical trial NCT01147068: Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza
Lead sponsor: Protein Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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 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).

Primary outcomes:
measure: Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.
timeFrame: 42 Days
Secondary outcomes:
measure: 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.
timeFrame: Day 0, and Day 42
measure: Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age
timeFrame: 21 Days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
Study officials:
affiliation: University of Rochester
name: John Treanor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.