Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

Influenza Clinical Trial

Official title:

Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395174
• Other study ID #: PSC03
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2006
• Last updated: December 16, 2009
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2009
• Source: Protein Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.

Description:

Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.

Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Ambulatory adults aged 65 and older

• Medically stable, as determined by oral temperature <100.0°F, medical history, and targeted physical examination based on medical history

• Able to understand and comply with planned study procedures

• Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

• Known allergy to eggs or other vaccine components.

• Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.

• Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.

• Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed).

• Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia

• History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.

• Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.

• History of severe reactions following immunization with influenza virus vaccines.

• Moderate to severe acute illness or febrile illness (oral temperature greater than 100*F) within 1 week prior to vaccination.

• Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.

• Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.

• History of alcohol or drug abuse in the last 5 years.

• History of Guillain-Barré Syndrome.

• Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza Vaccination
0.5mL dose for intramuscular injection

Locations

Country	Name	City	State
United States	Center of Vaccine Development, Univ. of Maryland	Baltimore	Maryland
United States	Passport Health Maryland	Baltimore	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	Primary Physicians Research	Pittsburg	Pennsylvania
United States	Mayo Clinic College of Medicine	Rochester	Minnesota
United States	Rochester Medical Center	Rochester	New York
United States	Passport Health New Jersey	Shrewsbury	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Protein Sciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Keitel WA, Treanor JJ, El Sahly HM, Gilbert A, Meyer AL, Patriarca PA, Cox MM. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or =65 years old. Vaccine. 2009 Dec 11;28(2):379 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older.		influenza season	Yes
Secondary	Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older.		influenza season	No
Secondary	Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older.		influenza season	No

External Links

•   Link