- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147068
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66210
- Vince and Associates Clinical Research
-
-
Nebraska
-
Omaha, Nebraska, United States, 68134
- Meridian Clinical Research
-
-
New York
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Rochester, New York, United States, 14642
- University of Rochester
-
-
Texas
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Fort Worth, Texas, United States, 76135
- Benchmark Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PanBlok 135µg No Adjuvant
135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
Experimental: PanBlok 45µg No Adjuvant
45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
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
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
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
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
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
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
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
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
Placebo Comparator: Placebo
0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart
|
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
Time Frame: 21 Days
|
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
|
21 Days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSC22 GLA-SE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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