H5N1 (Clade 2) Vaccination of Adults and Elderly

NCT00680069 | Completed Phase 1

• 1 other identifier: 07-0022
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.

Conditions

Influenza

Keywords

avian influenza,H5N1,Influenza,parent protocol

Outcome Measures

Primary Outcomes (1)

• Immune responses approximately 28 days after one dose of an H5N1 clade 2 vaccine.

  Approximately Day 28.

Secondary Outcomes (2)

• Immunologic outcomes include antibodies generated against strains other than A/Indonesia/05/05.

  Blood samples taken prior to vaccination on Day 0, and 28 days and 6 months after receipt of last vaccination testing.

• Safety outcomes include frequencies and severities of adverse events (AEs) in the high- and low-dose groups in aggregate, and in other strata previously identified.

  Duration of Study

Study Arms (2)

High Dose Group

EXPERIMENTAL

Volunteers will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart

Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005

Low Dose Group

EXPERIMENTAL

Volunteers will receive 15 mcg intramuscularly (IM). Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart.

Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005

Interventions

Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 BIOLOGICAL

Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart.

High Dose Group; Low Dose Group

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must have previously received at least 2 doses via the intramuscular route of placebo or vaccine derived from A/H5N1/VN/1203/04 as part of one of the following DMID Protocol Nos.: 04-062, 04-063 (and 05-0090), 04-076, 05-0015, 05-0127, 05-0141, or 06-0089; or the subject must have received placebo intramuscularly as part of DMID Protocol No. 06-0052. -The subject must be 19 years old or older. -Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception, including, but not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -For a female subject of childbearing potential, she must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination. -The subject is in good health, as determined by vital signs (heart rate less than 100 bpm; blood pressure: systolic greater than or equal to 90 mm Hg and less than or equal to 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature less than 100.0 degrees Fahrenheit), medical history to ensure stable medical condition, and a targeted physical examination, when necessary, based on medical history. A systolic blood pressure of less than or equal to 160 and a diastolic blood pressure of less than or equal to 90 is acceptable in subjects greater than 65 years of age. -The subject is able to understand and comply with the planned study procedures, including being available for all study visits. -The subject has provided informed consent prior to any study procedures.

You may not qualify if:

• The subject is allergic to eggs, egg products, chicken or egg proteins or other components of the vaccine (including gelatin, formaldehyde, octoxinol and thimerosal). -The subject is a woman who is breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -The subject is immunosuppressed 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. -The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. An active neoplastic disease is defined as treatment for neoplastic disease within the past 5 years. -The subject has long-term (greater than 2 weeks) use of oral or parenteral glucocorticoids, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). -The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. -The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for prior placebo recipients). -The subject has an acute or chronic medical condition that would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: solicited reactogenicity symptoms, 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 as there has been no dose adjustment with the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York 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). -The subject has a history of a severe reaction following receipt of an influenza virus vaccine. -The subject has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. -The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. -The subject has 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. -The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. -The subject has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others. -The subject is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study. -The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment. -The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection. -The subject has a history of Guillain-Barré syndrome. -The subject has any condition that the investigator believes may interfere with successful completion of the study. The subject plans to enroll in another clinical trial that has a study intervention such as a drug, biologic, or device that could interfere with safety assessment of the investigational product at any time during the study period.

Sponsors & Collaborators

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

Study Sites (8)

Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases

Stanford, California, 94305-2200, United States

Location

University of Iowa - Vaccine Research and Education Unit

Iowa City, Iowa, 52242-2600, United States

Location

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Baltimore, Maryland, 21201-1509, United States

Location

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104-1015, United States

Location

Duke Translational Medicine Institute - Clinical Vaccine Unit

Durham, North Carolina, 27704-2120, United States

Location

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45229-3039, United States

Location

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, 37232-2573, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Related Publications (2)

• Winokur PL, Patel SM, Brady R, Chen WH, El-Kamary SS, Edwards K, Creech CB, Frey S, Keitel WA, Belshe R, Walter E, Bellamy A, Hill H. Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine. J Infect Dis. 2015 Aug 15;212(4):525-30. doi: 10.1093/infdis/jiv087. Epub 2015 Feb 23.

  PMID: 25712967 RESULT

• Belshe RB, Frey SE, Graham IL, Anderson EL, Jackson LA, Spearman P, Edupuganti S, Mulligan MJ, Rouphael N, Winokur P, Dolor RJ, Woods CW, Walter EB, Chen WH, Turley C, Edwards KM, Creech CB, Hill H, Bellamy AR; National Institute of Allergy and Infectious Diseases-Funded Vaccine and Treatment Evaluation Units. Immunogenicity of avian influenza A/Anhui/01/2005(H5N1) vaccine with MF59 adjuvant: a randomized clinical trial. JAMA. 2014 Oct 8;312(14):1420-8. doi: 10.1001/jama.2014.12609.

  PMID: 25291578 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 30, 2016

Record last verified: 2015-08

Locations

US (8)