High Dose Influenza in Immunosuppressed Subjects

NCT00766285 | Withdrawn Phase 2

• 1 other identifier: 06-0069
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza is a common infection of the upper airways and lungs, and is caused by viruses. Cancer patients may need a stronger influenza vaccine than the general population to protect against influenza. The experimental vaccine is designed to be 9 times stronger than the standard vaccine, which may cause a stronger immune response against influenza in patients with a weakened immune system. The goal of this study is to compare the effects of a new experimental influenza vaccine to the effects of the standard influenza vaccine. One hundred bone marrow recipients, adult volunteers from the MD Anderson Cancer Center, 18 years of age or older, will participate in this study. They will be randomly (by chance) assigned to receive 2 doses of either the standard licensed influenza vaccine or the experimental influenza vaccine. Participants will be asked to complete 5 study visits and 3 telephone contacts. Study procedures include blood draws. The duration of participation is about 6 months.

Conditions

Influenza

Keywords

Baculovirus, influenza, stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Frequency of four-fold or greater serum hemagglutination inhibition (HAI) and/or neutralization antibody rises in the 2 groups to the 3 hemagglutinin (HA) types (H1, H3, and B) contained within the vaccine.

  At Days 28 and 56 after the first vaccine dose.

Secondary Outcomes (4)

• The frequencies and severity of solicited local and systemic adverse events in each vaccine dosage group.

  Day 0 through Day 7 following all vaccinations.

• The geometric mean titer (GMT) of serum HAI and serum neutralizing antibody against the influenza A/H3N2, H1N1, and B virus.

  1 month after each vaccination.

• The proportion of subjects in each vaccine dose group that achieves a HAI titer of at least 1:32.

  28 days after the first and second dose of vaccine.

• Adverse events (AE) or serious adverse events (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessment).

  Duration of study.

Study Arms (2)

TIV

ACTIVE COMPARATOR

50 subjects to receive 45 mcg of TIV administered on Day 0 and Day 28.

Biological: Trivalent inactivated influenza vaccine

rHAO

EXPERIMENTAL

50 subjects to receive 405 mcg of rHAO administered on Day 0 and Day 28.

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

Interventions

Trivalent inactivated influenza vaccine BIOLOGICAL

Standard trivalent influenza vaccine consisting of 15 mcg per antigen (45 mcg total) by intramuscular deltoid injection.

TIV

Trivalent Baculovirus-expressed Influenza HA vaccine BIOLOGICAL

Influenza virus hemagglutinin proteins expressed in insect (SF+) cells under serum free conditions by recombinant baculovirus.

rHAO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age, between 6 and 12 months after undergoing their last allogeneic donor hematopoietic stem cell transplantation with no or stable chronic graft versus host disease (score 0-1).
• Underlying cancer is stable or in complete remission within 3 months prior to enrollment as determined by the treating oncologist in written documentation stating such fact.
• Ambulatory; community dwelling. Subjects will be considered ambulatory if they are not institutionalized, bedridden or homebound.
• Able to return to the clinical site for reactogenicity examinations for at least 7 days after each injection.
• Patients with stable chronic viral infection \[(other than Hepatitis B or C and human immunodeficiency virus (HIV)\]; any bacterial, mycobacterial or invasive fungal infections that are on maintenance antimicrobial therapy are eligible. Antimicrobial therapy includes: any antiviral, antibacterial or antifungal therapy use under the standard guidelines for treatment or maintenance treatment of viral, bacterial or invasive fungal infections.
• Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods as recommended by her primary care provider) from at least 30 days prior to enrollment and for at least 3 months after receipt of dose 2.
• Able to understand and comply with planned study procedures.
• Provides informed consent prior to initiation of any study procedures and is available for all study visits.

You may not qualify if:

• Has moderate or severe chronic graft versus host disease (score 2-3) or uncontrolled chronic graft-versus-host disease (GvHD).
• Has required high-dose corticosteroids: \>16 mg prednisone or equivalent daily dose (high-dose methylprednisolone, high-dose dexamethasone), or receiving immunosuppressive agents such as tacrolimus, antithymocyte globulins, cyclosporine, or methotrexate in past 4 weeks.
• Has long-term use (greater than 4 weeks) of moderate to high-dose inhaled steroids (e.g., more than the equivalent of 264 mcg fluticasone; 600 mcg budesonide; 240 mcg beclomethasone; 1000 mcg flunisolide, 750 mcg triamcinolone or 200 mcg mometasone, as a daily dose) within 1 month prior to enrollment.
• Has received chemotherapy within the past 3 months for a refractory or relapsed cancer.
• Was given rituximab or ibritumomab tiuxetan in the past 6 months.
• Splenectomized individuals.
• Has a known allergy to eggs or other components of the vaccine (i.e., thimerosal) or a severe reaction to influenza vaccine in the past.
• Has an acute or chronic condition or an acute change in a chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses including but not limited to the following: acute febrile illness, known chronic liver disease \[history of increased alanine transaminase (ALT) and aspartate aminotransferase (AST) levels in the past 4 weeks\]; significant renal disease on dialysis; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV; unstable or progressive neurologic disorder; or uncontrolled diabetes mellitus. Medically unstable patients with systolic blood pressure \< 90 mmHg, pulse \> 100 beats per minutes, or respiratory rate of \> 24 per minutes will not be included in this study.
• Has received immunoglobulin within 3 months or monoclonal antibodies within 4 weeks prior to enrollment into the study.
• Has a history of Guillian-Barré Syndrome, vasovagal syncope, clinically symptomatic pericardial effusion or cardiac tamponade, or Bell's palsy.
• Has an acute illness including an oral temperature greater than or equal to 100.0 degrees Fahrenheit, within one week prior to vaccination.
• Has a known history of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C. Screening for HIV will not be performed for this study.
• Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is breast-feeding, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
• Has received the current licensed trivalent influenza vaccine within the past 4 weeks.
• Has received an investigational agent (drug, vaccine, biologic agent or a device) within 4 weeks before vaccination, or expects to receive an experimental agent prior to completing study visit 5.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

The University of Texas - MD Anderson Cancer Center - Infectious Diseases

Houston, Texas, 77030-4000, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 3, 2015

Record last verified: 2009-12

Locations

US (1)