Higher Dose Intradermal H5 Vaccine

NCT00439335 | Completed Phase 1 Results

• 1 other identifier: 06-0089
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.

Conditions

Influenza

Keywords

Influenza, vaccine, A/H5N1

Outcome Measures

Primary Outcomes (5)

• Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2

  Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine

  Approximately Day 56.

• Number of Participants Spontaneously Reporting Any Serious Adverse Event.

  Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.

  Through Day 208.

• Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.

  The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.

  Through approximately Day 56

• Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.

  The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.

  7 days after each vaccination

• Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.

  The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.

  7 days after each vaccination

Secondary Outcomes (8)

• HAI Geometric Mean Titer (GMT) After Dose 2

  Approximately Day 56.

• Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2

  Approximately Day 56

• Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.

  Approximately Day 28

• HAI GMT After Dose 1

  Approximately Day 28

• Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.

  Approximately Day 28

Study Arms (2)

H5 HA IM

EXPERIMENTAL

Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.

Biological: Inactivated Influenza A Vaccine A/H5N1; Drug: Placebo (ID)

H5 HA ID

EXPERIMENTAL

Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.

Biological: Inactivated Influenza A Vaccine A/H5N1; Drug: Placebo (IM)

Interventions

Inactivated Influenza A Vaccine A/H5N1 BIOLOGICAL

Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection. Vaccine will be administered to each subject at Days 0 and 28.

H5 HA IM

Placebo (IM) DRUG

The placebo will be 0.1 mL of saline administered by the IM route.

H5 HA ID

Placebo (ID) DRUG

The placebo will be 0.1 mL of saline administered by the ID route.

H5 HA IM

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female between the ages of 18 and 49 years, inclusive.
• Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to 1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, or licensed hormonal methods) for the entire study period.
• Is in good health, as determined by vital signs (heart rate less than 100 beats per minute; blood pressure: systolic less than or equal to 140 mm Hg and greater than or equal to 90 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 (see definition below) and a 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 procedures.

You may not qualify if:

• Has a known allergy to eggs or other components of the vaccine.
• Has a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential), is breastfeeding, or has the intention to become pregnant during the study period.
• Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• Has an active neoplastic disease or a history of any hematologic malignancy.
• Long term use of oral or parenteral steroids, high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
• Has a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
• Has a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
• Has been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
• Is receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
• Has 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).
• Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
• Has a moderate to severe acute illness and/or an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
• Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
• History of alcohol or drug abuse in the 5 years prior to enrollment.

Sponsors & Collaborators

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

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Patel SM, Atmar RL, El Sahly HM, Guo K, Hill H, Keitel WA. Direct comparison of an inactivated subvirion influenza A virus subtype H5N1 vaccine administered by the intradermal and intramuscular routes. J Infect Dis. 2012 Oct 1;206(7):1069-77. doi: 10.1093/infdis/jis402. Epub 2012 Aug 13.

  PMID: 22891287 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shital Patel, MD
• Organization: Baylor College of Medicine

shitalp@bcm.tmc.edu

713-798-3793

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: February 22, 2007
• First Posted: February 23, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 9, 2013
• Results First Posted: May 8, 2009

Record last verified: 2009-08

Locations

US (1)