Safety and Immunogenicity of PanBlok Influenza Vaccine in... | NCT01147068

NCT01147068

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PanBlok 135µg No Adjuvant	Experimental	135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart	Biological: 0.5mL Intramuscular Injection
PanBlok 45µg No Adjuvant	Experimental	45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart	Biological: 0.5mL Intramuscular Injection
PanBlok 45µg and GLA 1.0µg, SE 2%	Experimental	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	Biological: 0.5mL Intramuscular Injection
PanBlok 15µg and GLA 1.0µg, SE 2%	Experimental	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	Biological: 0.5mL Intramuscular Injection
PanBlok 7.5µg and GLA 1.0µg, SE 2%	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5mL Intramuscular Injection	Biological	0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle	PanBlok 135µg No Adjuvant PanBlok 15µg and GLA 1.0µg, SE 2%

Outcomes Module

Primary Outcomes

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.	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

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.	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.

Eligibility Module

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).

Name	Affiliation	Role
John Treanor, MD	University of Rochester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vince and Associates Clinical Research		Overland Park	Kansas	66210	United States
Meridian Clinical Research

PubMed Identifier	Type	Citation	Retractions
24075920	Derived	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.

Label	URL
Related Info	View source

Arm/Group Information

ID	Title	Description
FG000	Placebo	0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG001	PanBlok 135µg No Adjuvant	135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG002	PanBlok 45µg No Adjuvant	45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG003	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 : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG004	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 : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG005	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 : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
FG006	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 : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

Periods

Title

Milestones

Reasons Not Completed

Subjects That Received 1st Dose

Type	Comment	Milestone Data
STARTED		FG00060 subjects FG00157 subjects FG00255 subjects FG00356 subjects FG004
COMPLETED		FG00060 subjects FG00157 subjects FG00255 subjects FG00356 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Subjects That Received 2nd Dose

Type	Comment	Milestone Data
STARTED		FG00060 subjects FG00157 subjects FG00255 subjects FG003

Subjects That Completed Safety Follow-up

Type	Comment	Milestone Data
STARTED		FG00060 subjectsParticipants were eligible for follow-up regardless of number of doses received. FG00157 subjectsOne subject was ineligible, one subject did not complete the study, and the other data is unknown. FG00255 subjectsData on three subjects is unknown. FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
BG001	PanBlok 135µg No Adjuvant

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous	The median was measured based on the total population of each arm.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.

Posted

Number

95% Confidence Interval

percentage of participants

42 Days

ID	Title	Description
OG000	Placebo	0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart 0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics