Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum Hydroxide; Vaccines

Criteria

Inclusion Criteria:

Stage 1 Cohort

• Healthy males and females aged 18 to 40 years, inclusive;

• Females of childbearing potential must agree to practice adequate contraception for the duration of the study (not surgically sterile or Aftermenopausal for at least 1 year);

• Good health as determined by screening medical history and physical examination;

• On no medications with the exception of licensed hormonal contraceptives and vitamins;

• Willingness to comply with study procedures;

• Ability to provide informed consent;

• Availability for follow-up for 6 months after second vaccination;

• Normal screening laboratory values for total WBC, platelet count, hemoglobin, creatinine, and alanine aminotransferase (Stage 1 only).

Stage 2 Cohort

• Healthy males and non-pregnant females aged 18 to 40 years, inclusive.

• Females of childbearing potential must agree to practice adequate contraception for the duration of the study.

• Good health as determined by screening medical history and physical examination.

• Willingness to comply with study procedures.

• Ability to provide informed consent.

• Availability for follow-up for 6 months after second vaccination.

Exclusion Criteria:

Stage 1 Cohort

• Have a positive urine or serum pregnancy test in the 24 hours prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.

• Have immunosuppression as a result of an underlying illness or treatment, 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 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)

• 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.

• Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination 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 F, 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.

• Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.

• Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).

• Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.

• Have a history of alcohol or drug abuse in the last 5 years.

• Have a history of Guillain Barre Syndrome.

• Have any condition that the investigator believes may interfere with successful completion of the study.

Stage 2 Cohort

• Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.

• Have immunosuppression as a result of an underlying illness or treatment, 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 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed.)

• 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.

• Are receiving psychiatric drugs*. Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.

• aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate.

• Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination 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 F, 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.

• Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.

• Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).

• Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.

• Have a history of alcohol or drug abuse in the last 5 years.

• Have a history of Guillain Barre Syndrome.

• Have any condition that the investigator believes may interfere with successful completion of the study.