This study is NOT currently recruiting participants.
Number
12-I-0103
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
No
Population Exclusion(s)
Children
Keywords
H5N1 Vaccine; H5N1 Immunization; AS03 Adjuvant; Biologic Sample Collection; Laboratory Research Specimens
Recruitment Keyword(s)
Healthy Volunteer; HV
Condition(s)
Influenza
Investigational Drug(s)
H5N1 vaccine with AS03 adjuvant H5N1 vaccine without adjuvanted
Investigational Device(s)
None
Intervention(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.
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.
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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.
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.
Principal Investigator
Referral Contact
For more information: