Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
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
1 other identifier
interventional
392
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
November 26, 2012
CompletedNovember 26, 2012
October 1, 2012
1.3 years
June 16, 2010
October 24, 2012
October 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.
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.
42 Days
Secondary Outcomes (2)
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.
Day 0, and Day 42
Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age
21 Days
Study Arms (7)
PanBlok 135µg No Adjuvant
EXPERIMENTAL135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
PanBlok 45µg No Adjuvant
EXPERIMENTAL45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
PanBlok 45µg and GLA 1.0µg, SE 2%
EXPERIMENTAL45µg 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
PanBlok 15µg and GLA 1.0µg, SE 2%
EXPERIMENTAL15µg 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
PanBlok 7.5µg and GLA 1.0µg, SE 2%
EXPERIMENTAL7.5µg 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
PanBlok 3.8µg and GLA 1.0µg, SE 2%
EXPERIMENTAL3.8µg 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
Placebo
PLACEBO COMPARATOR0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
Interventions
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Vince and Associates Clinical Research
Overland Park, Kansas, 66210, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
University of Rochester
Rochester, New York, 14642, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Related Publications (1)
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.
PMID: 24075920DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The absence of a treatment group receiving a SE- or GLA-alone adjuvanted vaccine formulation is a limitation to the study conclusion.
Results Point of Contact
- Title
- Dr. Ruvim Izikson, M.D.
- Organization
- Protein Sciences Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
John Treanor, MD
University of Rochester
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CEO
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 22, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 26, 2012
Results First Posted
November 26, 2012
Record last verified: 2012-10