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

NCT01910519 | Completed Phase 2 Results DMC

• 2 other identifiers: DAIT HIPC: VAX-0101U19AI090023-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza A Virus, H5N1 Subtype

Keywords

influenza A (H5N1) virus; H5N1 influenza; influenza A/H5/N1; monovalent H5N1 influenza vaccine; systems biology; AS03 adjuvant; unadjuvanted

Outcome Measures

Primary Outcomes (10)

• 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

  To identify innate immune signatures; 1 day post first vaccination

  Day 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

  To identify innate immune signatures; 3 days post first vaccination

  Day 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

  To identify innate immune signatures; 7 days post first vaccination

  Day 7

• 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

  To identify innate immune signatures; 1 day post second vaccination

  Day 22

• 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

  To identify innate immune signatures; 3 days post second vaccination

  Day 24

• 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

  To identify innate immune signatures; 7 days post second vaccination

  Day 28

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

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

  Day 21

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

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

  Day 21

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

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

  Day 42

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

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

  Day 42

Study Arms (2)

H5N1 vaccine plus AS03 adjuvant

EXPERIMENTAL

H5N1 vaccine plus AS03 adjuvant: Influenza A Vaccine with AS03 adjuvant Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21).

Biological: H5N1 vaccine plus AS03 adjuvant

H5N1 vaccine without adjuvant

EXPERIMENTAL

H5N1 vaccine without adjuvant: Influenza A Vaccine without AS03 adjuvant Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21).

Biological: H5N1 vaccine without adjuvant

Interventions

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.

Also known as: Q-Pan H5N1, adjuvanted Q-Pan H5N1

H5N1 vaccine plus AS03 adjuvant

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.

Also known as: unadjuvanted H5N1 vaccine

H5N1 vaccine without adjuvant

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The Hope Clinic - Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

Related Publications (1)

• Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.

  PMID: 34174187 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)

MeSH Terms

Conditions

Influenza in Birds; Virus Diseases

Interventions

AS03 adjuvant; Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Infections; Bird Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Results Point of Contact

• Title: Nadine Rouphael MD
• Organization: Emory University

nroupha@emory.edu

404-712-1435

Study Officials

• Nadine Rouphael, MD

  Hope Clinic, Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 29, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01

Locations

US (1)