Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
PSC25
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
1 other identifier
interventional
341
1 country
5
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 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2012
5 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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
November 25, 2015
CompletedNovember 25, 2015
October 1, 2015
1.3 years
May 7, 2012
December 19, 2014
October 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
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 a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
42 Days
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
42 Days
Secondary Outcomes (2)
Reactogenicity Immediately After Each Injection, Extending to Day 7.
7 Days
Long-term Safety
13 Months
Study Arms (4)
PanBlok 15µg in 2% SE
EXPERIMENTAL15µg 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
PanBlok 3.8µg in 2% SE
EXPERIMENTAL3.8µg 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
PanBlok 7.5µg No Adjuvant
EXPERIMENTAL7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
PanBlok 7.5µg in 2% SE
EXPERIMENTAL7.5µg 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
Interventions
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- Young adults aged 18-49 years
- Able to give written informed consent to participate.
- Vital signs within normal limits.
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
University of Rochester Center for Vaccine Studies
Rochester, New York, 14627, United States
Benchmark Reseach
Austin, Texas, 78705, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
Treanor JJ, Chu L, Essink B, Muse D, El Sahly HM, Izikson R, Goldenthal KL, Patriarca P, Dunkle LM. Stable emulsion (SE) alone is an effective adjuvant for a recombinant, baculovirus-expressed H5 influenza vaccine in healthy adults: A Phase 2 trial. Vaccine. 2017 Feb 7;35(6):923-928. doi: 10.1016/j.vaccine.2016.12.053. Epub 2017 Jan 11.
PMID: 28089141DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa M. Dunkle, M.D., Chief Medical Officer
- Organization
- Protein Sciences Corproation
Study Officials
- PRINCIPAL INVESTIGATOR
John J Treanor, MD
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2012
First Posted
June 5, 2012
Study Start
May 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
November 25, 2015
Results First Posted
November 25, 2015
Record last verified: 2015-10