Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04
NCT ID: NCT00814385
Last Updated: 2014-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
606 participants
INTERVENTIONAL
2008-11-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
NCT00943358
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
NCT01776541
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines
NCT00478816
Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
NCT00349141
Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59
NCT00912496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Immunogenicity objectives
1. To evaluate the magnitude of the antibody responses to one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine, each dose containing 7.5μg of H5N1 haemagglutinin, in immunologically naïve subjects;
2. To examine the kinetics of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
3. To evaluate the magnitude of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75μg or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
4. To evaluate the breadth of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above), with respect to a representative range of antigenically distinct H5N1 viruses (wild-type and attenuated); and
5. To evaluate the persistence of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above).
Safety objective
1\. To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine, or non-adjuvanted antigenically drifted H5N1 vaccine.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vaccine arm 1
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks
Aflunov (Single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Vaccine arm 2
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks
Aflunov (Single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Vaccine arm 3
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks
Aflunov (single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Vaccine arm 4
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks
Aflunov (single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Vaccine arm 5
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks
Aflunov (Double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
vaccine arm 6
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Vaccine arm 7
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Vaccine arm 8
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Vaccine arm 9
No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks
Aflunov (No prime, single boost)
No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aflunov (Single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (Single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (single prime, single boost)
Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (Double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (double prime, single boost)
Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Aflunov (No prime, single boost)
No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Are in good health or have one or more stable (See footnote) medical conditions, as determined by:
1. Medical history,
2. Physical examination,
3. Clinical judgment of the medical investigator;
3. Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
4. Subjects who experienced fever (defined as axillary temperature \>38oC) within 3 days prior to Visit 1;
5. Subjects who are pregnant or breastfeeding;
6. Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject's study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse);
7. Subjects with any serious disease, including:
1. cancer,
2. acute or progressive hepatic disease,
3. acute or progressive renal disease,
4. chronic pulmonary disease requiring home oxygen therapy,
5. active neurological disorder,
6. autoimmune disease (including rheumatoid arthritis);
8. Subjects for whom surgery is planned during the study period;
9. Subjects with a bleeding diathesis;
10. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin, or any other component of the study vaccine;
11. Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine;
12. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
1. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or cancer chemotherapy) (long-term, inhaled steroids for asthma management is acceptable),
2. receipt of immunostimulants or interferon,
3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5 (Day 382), or planned during the full length of the study,
4. high risk from developing an immunocompromising disease;
13. Actual or planned receipt of another vaccine during the period 3 weeks before to 3 weeks after vaccination on Days 1, 22, and 382;
14. Subjects with a history of (or current) drug or alcohol abuse (20g/day for females; 30g/day for males) that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
15. Subjects who are unable to lead an independent life either physically or mentally;
16. Have participated in a previous study of H5 avian influenza vaccine;
17. Have been previously vaccinated with a vaccine containing MF59 or similar adjuvant;
18. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Novartis
INDUSTRY
Public Health England
OTHER_GOV
National Institute of Biological Standards and Control
OTHER_GOV
University Hospitals, Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl G Nicholson, FRCP, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals Leicester
Leicester, Leicestershire, United Kingdom
Clincal Trials Unit Leicester Royal Infirmary
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UHL10492
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.