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Protocol Details

Characterization of Innate Immune Responses to AS03 Adjuvanted H5N1 Vaccine Compared to Non-adjuvanted H5N1 Vaccine

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 21 Years
Max Age: 45 Years

Referral Letter Required


Population Exclusion(s)



H5N1 Vaccine;
H5N1 Immunization;
AS03 Adjuvant;
Biologic Sample Collection;
Laboratory Research Specimens

Recruitment Keyword(s)

Healthy Volunteer;



Investigational Drug(s)

H5N1 vaccine with AS03 adjuvant
H5N1 vaccine without adjuvanted

Investigational Device(s)



Biological/Vaccine: H5N1 vaccine plus AS03 adjuvant
Biological/Vaccine: H5N1 vaccine without adjuvant

Supporting Site

National Institute of Allergy and Infectious Diseases


- 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.


- To compare the healthy immune system responses to bird flu vaccine with or without the AS03 adjuvant.


- Healthy volunteers between 18 and 45 years of age.


- 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.

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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.


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.

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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.

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. 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].

Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80.

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Principal Investigator

Referral Contact

For more information:

Pamela L. Schwartzberg, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 4
Room RM 228
4 Memorial Drive
Bethesda, Maryland 20892
(240) 669-5598

Laura E. Failla, C.R.N.P.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM 134
(240) 669-5323

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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