Influenza Clinical Trial
Official title:
Characterization of Innate Immune Responses to AS03 Adjuvanted H5N1 Vaccine Compared to Non-adjuvanted H5N1 Vaccine
Verified date | September 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Adjuvants are substances included in vaccines that stimulate the immune system and increase
the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in
Europe. However, it has not been fully tested in the United States. Researchers want to test
the immune responses of people who receive a bird flu vaccine with or without AS03 to better
understand how the adjuvant works. This information may help develop better flu vaccines.
Objectives:
- To compare the healthy immune system responses to bird flu vaccine with or without the AS03
adjuvant.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will be assigned to one of two groups. Each group will have an initial
vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the
same type of vaccine. One group will have the vaccine with AS03; the other group will
have the vaccine without it.
- All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay
will involve the vaccination, followed by regular and frequent blood draws. Participants
will be monitored for any signs or symptoms that may be caused by the vaccine.
- Additional blood samples will be collected 7, 28, 42, and 100 days after the initial
vaccination.
Status | Completed |
Enrollment | 43 |
Est. completion date | January 31, 2016 |
Est. primary completion date | January 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
- INCLUSION CRITERIA: 1. Healthy status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol. 2. Age 21 years to 45 years 3. Able to comprehend the investigational nature of the protocol and provide informed consent 4. Must be willing to use effective birth control for one month before, during and for two months after the last vaccination. EXCLUSION CRITERIA: 1. Severe allergies to eggs or their products, chicken proteins or to any component of the influenza antigen preparation. 2. Recipient of AS03 vaccine at any time in the past 3. Recipient of the seasonal influenza vaccine within the past 3 months. 4. Prior severe reactions to vaccines, including influenza vaccines (e.g. anaphylaxis, angioedema or urticaria) 5. Participation on any blood collection or blood donation procedure during study that will bring the total blood draw >550ml over 8 weeks 6. Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual) 7. Currently breast-feeding 8. History of Guillain Barre syndrome 9. Acute illness with patient reported temperature of 38 (Infinite)C or greater within 3 days prior to the proposed time of administration. 10. Any history or presence of serious illness, bleeding disorders or autoimmune disorders, or planned surgeries. 11. Weight less than 50 kg (110 pounds) 12. History of hepatitis or liver disease. 13. Subjects receiving immunosuppressive therapy. 14. Presence of HLA DQB1*06:02, the narcolepsy risk associated allele. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. Epub 2006 Sep 25. — View Citation
Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. Erratum in: PLoS ONE. 2009;4(3). doi: 10.1371/annotation/5f2ae0fb-53f1-48c2-aa19-9114765ba029. Capecchi, Pamela [corrected to Capecchi, Pier Leopoldo]. — View Citation
Khurana S, Coyle EM, Manischewitz J, King LR, Gao J, Germain RN, Schwartzberg PL, Tsang JS, Golding H; and the CHI Consortium. AS03-adjuvanted H5N1 vaccine promotes antibody diversity and affinity maturation, NAI titers, cross-clade H5N1 neutralization, b — View Citation
Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flu Antibody Titers | Flu Antibody titers at days 0, 21, 42, 100. Antibody-neutralization titers by microneutralization were measured against five different H5N1 virus strains (i.e., A/Vietnam/1194/2004 (clade 1), A/Indonesia/5/2005 (clade 2.1), A/Turkey/15/2006 (clade 2.2), A/Egypt/3072/2010 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4)) at day 0 (prevaccination), day 21 (post first vaccination), day 42 (post second vaccination) and day 100 postvaccination for AS03-adjuvanted group and unadjuvanted group. Sera were tested at an initial dilution of 1:20, and those that were negative (<1:20) were assigned a titer of 10. | Days 0, 21, 42, and 100 |
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