Back to results

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

0.5mL Intramuscular Injection

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Vince and Associates Clinical Research
Meridian Clinical Research
University of Rochester
Benchmark Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Arm Label

PanBlok 135µg No Adjuvant

PanBlok 45µg No Adjuvant

PanBlok 45µg and GLA 1.0µg, SE 2%

PanBlok 15µg and GLA 1.0µg, SE 2%

PanBlok 7.5µg and GLA 1.0µg, SE 2%

PanBlok 3.8µg and GLA 1.0µg, SE 2%

Placebo

Arm Description

135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart

45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart

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

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

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

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

0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age

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

Full Information

NCT ID

NCT01147068

First Posted

June 16, 2010

Last Updated

October 24, 2012

Sponsor

Protein Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01147068

Brief Title

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Protein Sciences Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PanBlok 135µg No Adjuvant

Arm Type

Experimental

Arm Description

135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart

Arm Title

PanBlok 45µg No Adjuvant

Arm Type

Experimental

Arm Description

45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart

Arm Title

PanBlok 45µg and GLA 1.0µg, SE 2%

Arm Type

Experimental

Arm Description

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

Arm Title

PanBlok 15µg and GLA 1.0µg, SE 2%

Arm Type

Experimental

Arm Description

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

Arm Title

PanBlok 7.5µg and GLA 1.0µg, SE 2%

Arm Type

Experimental

Arm Description

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

Arm Title

PanBlok 3.8µg and GLA 1.0µg, SE 2%

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart

Intervention Type

Biological

Intervention Name(s)

0.5mL Intramuscular Injection

Other Intervention Name(s)

rHA, recombinant hemagglutinin, PanBlok

Intervention Description

0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

Primary Outcome Measure Information:

Title

Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.

Description

Time Frame

42 Days

Secondary Outcome Measure Information:

Title

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.

Description

Time Frame

Day 0, and Day 42

Title

Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age

Description

Time Frame

21 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Treanor, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Meridian Clinical Research

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Benchmark Research

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24075920

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.

Results Reference

derived

Links:

URL

http://proteinsciences.com

Description

Related Info

Learn more about this trial

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

We'll reach out to this number within 24 hrs