Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults

NCT00546585 | Completed Phase 1

• 1 other identifier: 07-0023
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine \[Inactivated Influenza A/H7N7 Vaccine\] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.

Conditions

Influenza

Keywords

influenza, inactivated influenza A/H7N7 vaccine, parent protocol

Outcome Measures

Primary Outcomes (3)

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

  Duration of study.

• Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus.

  28 days after receipt of the second dose of vaccine (approximately Day 56).

• Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group.

  1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.

Study Arms (5)

90 mcg of Influenza A/H7N7

EXPERIMENTAL

25 subjects to receive 90 mcg of Influenza A/H7N7.

Biological: Influenza A/H7N7 Vaccine

15 mcg of Influenza A/H7N7

EXPERIMENTAL

25 subjects to receive 15 mcg of Influenza A/H7N7.

Biological: Influenza A/H7N7 Vaccine

7.5 mcg of Influenza A/H7N7

EXPERIMENTAL

25 subjects to receive 7.5 mcg of Influenza A/H7N7.

Biological: Influenza A/H7N7 Vaccine

45 mcg of Influenza A/H7N7

EXPERIMENTAL

25 subjects to receive 45 mcg of Influenza A/H7N7.

Biological: Influenza A/H7N7 Vaccine

Saline placebo

PLACEBO COMPARATOR

25 subjects to receive placebo.

Drug: Placebo

Interventions

Influenza A/H7N7 Vaccine BIOLOGICAL

Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.

15 mcg of Influenza A/H7N7; 45 mcg of Influenza A/H7N7; 7.5 mcg of Influenza A/H7N7; 90 mcg of Influenza A/H7N7

Placebo DRUG

Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.

Saline placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
• 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, intrauterine devices, and licensed hormonal methods) for the entire study period.
• Able to understand and comply with planned study procedures.
• Provide informed consent prior to initiation of any study procedures and are available for all study visits.

You may not qualify if:

• Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, aluminum hydroxide, and chicken protein).
• Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
• Have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Have an active neoplastic disease or a history of any hematologic malignancy.
• Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed.)
• Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
• Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. (This includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
• Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
• Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expect to receive an experimental agent during the 7-month study period.
• Plan to enroll in another clinical trial at any time during the study period.
• Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
• Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.

Sponsors & Collaborators

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

Study Sites (1)

Baylor College of Medicine - Department of Molecular Virology and Microbiology

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Couch RB, Patel SM, Wade-Bowers CL, Nino D. A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine. PLoS One. 2012;7(12):e49704. doi: 10.1371/journal.pone.0049704. Epub 2012 Dec 11.

  PMID: 23239968 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 18, 2007
• First Posted: October 19, 2007
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 23, 2013

Record last verified: 2010-01

Locations

US (1)