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Completed

NCT Number: NCT01910519

Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)

This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

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Key information

Conditions

Influenza A Virus, H5N1 Subtype Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hope Clinic - Emory Vaccine Center

Decatur, Georgia, 30030, United States

About this study

The influenza virus (a germ) causes influenza or "flu." The flu is an infection of the breathing tubes and the lungs. In recent years, flu viruses that at first only infected birds have begun to infect humans. One of these strains is called avian influenza (A/H5N1 subtype) or "bird flu". Although no human cases of bird flu have been diagnosed in the United States, this strain has caused severe illness and death in several hundred people since late 2003. .

Vaccination is the most effective way of controlling flu and preventing its illness and complications. Vaccines help prevent illness by causing the body to make antibodies that fight infection. One way to improve the effectiveness of a vaccine is to include a substance that can stimulate the immune system to make more antibodies. This type of substance is called an adjuvant; one type of adjuvant is called AS03 (Adjuvant System 03).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals in good health (as determined by vital signs, medical history, physical examination and laboratory tests);
  • Able to understand and give informed consent;
  • Women of childbearing potential must agree to practice adequate contraception 1 month prior to study entry and until day 100 of the study.

Exclusion criteria

  • Personal or family history of sleeping disorders including any of the following: Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations (hypnagogic or hypnopompic hallucinations);
  • Human leukocyte antigen (HLA)-DQB1*06:02 positivity (or DQB1*06 positivity if high resolution HLA testing cannot be performed);
  • An abnormal erythrocyte sedimentation rate at baseline;
  • Receipt of blood products 3 months prior to study entry and until day 100 of the study;
  • Volunteers who donated blood 56 days before screening and have plans to donate on or before day 100 of the study;
  • Hemoglobin value of less than 12 mg/dL for females and less than 13 mg/dL for males;
  • A positive result in the Narcolepsy Mini Screen questionnaire;
  • A score of ≥11 on the Epworth sleepiness scale questionnaire;
  • Receipt of any experimental agents within 6 weeks prior to first vaccination and until the completion of the study;
  • Receipt of any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first study vaccination or planned receipt of any vaccine within 42 days after study entry;
  • Receipt of a H5 vaccine or AS03-adjuvanted vaccine at any time in the past prior to current study or have a history of A/H5N1 infection;
  • Influenza-like illness (ILI) or documented influenza infection during the 2013-2014 influenza season. [Not excluded from the study, volunteers with prior upper respiratory infections other than ILI];
  • Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, autoimmune disease, severe gastrointestinal disease;
  • Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data;
  • Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy, radiation therapy (past 36 months) or any other potentially immunosuppressive therapy [i.e. Systemic steroids at any dose and intra-articular administration of steroids in the past 3 months; (Nasal and topical steroids are allowed)], congenital immunodeficiency, anatomical or functional asplenia;
  • Heart rate less than 40 bpm or greater than 100 bpm. Systolic blood pressure is less than 90 mm Hg or equal or greater than 160 mm Hg. Diastolic blood pressure is less than 60 mm Hg or equal or greater than 100 mg Hg;
  • Pregnancy or postpartum (less than 1 year after delivery) or breast feeding;
  • Severe reactions to prior vaccination with influenza virus vaccines, including anaphylaxis;
  • History of Guillain-Barré syndrome;
  • A previous sudden life-threatening allergic reaction to any ingredient of Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant or to any of the substances that may be present in trace amounts such as thiomersal, egg residues including ovalbumin as well as residual amounts of sodium deoxycholate detergent, formaldehyde and sucrose;
  • Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0 C], regardless of the route) within 3 days prior to study entry;
  • Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.

Treatment and study plan

H5N1 vaccine plus AS03 adjuvant

Biological

Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.

Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.

Other names: Q-Pan H5N1, adjuvanted Q-Pan H5N1

H5N1 vaccine without adjuvant

Biological

Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant.

Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.

Other names: unadjuvanted H5N1 vaccine

Primary outcomes

  1. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 1

    To identify innate immune signatures; 1 day post first vaccination

  2. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 3

    To identify innate immune signatures; 3 days post first vaccination

  3. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 7

    To identify innate immune signatures; 7 days post first vaccination

  4. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 22

    To identify innate immune signatures; 1 day post second vaccination

  5. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 24

    To identify innate immune signatures; 3 days post second vaccination

  6. Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 28

    To identify innate immune signatures; 7 days post second vaccination

  7. Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 21

    To measure selective adaptive immune response; 21 days post first vaccination

  8. Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 21

    To measure selective adaptive immune response; 21 days post first vaccination

  9. Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 42

    To measure selective adaptive immune response; 21 days post second vaccination

  10. Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant

    Time frame: Day 42

    To measure selective adaptive immune response; 21 days post second vaccination

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Emory University

Registry information

Official study title

Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2013
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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