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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00703053 |
Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this virus may result in a widespread outbreak of bird flu. The purpose of this study is to evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants will be randomly assigned to 1 of 9 possible vaccine groups. All participants will receive 2 doses of Clade 1, Clade 2, or combination Clade 1 and 2 on Day 0. All participants will receive a second dose of the same vaccine or a different vaccine type on study day 7, 14, 28 or 180. Study participants will include about 500 healthy adult subjects, ages 18-49 years old, who have no history of prior H5 flu exposure or vaccination. Study procedures may include medical history, physical exam, and blood sampling. Subject participation may last up to 372 days. Several DMID studies have recently evaluated H5N1 vaccines in healthy adults, 04-063, 05-0090, 05-0015, and 05-0043.
Condition | Intervention | Phase |
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Influenza |
Biological: A/Indonesia/05/05 Biological: A/Vietnam/1203/04 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized Study of the Safety and Immunogenicity of Vaccination Strategies Using One or Two Clades and Different Schedules of H5N1 Unadjuvanted, Inactivated Subvirion Influenza Vaccines in H5 Naïve Healthy Adults |
Enrollment: | 505 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
25 subjects: Day 0, A/Vietnam/04 90 mcg; Day 7, A/Vietnam/04 90 mcg.
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Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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2: Experimental
25 subjects: Day 0, A/Vietnam/04 90 mcg; Day 14, A/Vietnam/04 90 mcg.
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Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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3: Experimental
50 subjects: Day 0, A/Indonesia/05 90 mcg; Day 28, A/Indonesia/05 90 mcg.
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Biological: A/Indonesia/05/05
Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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7: Experimental
50 subjects: Day 0: A/Indonesia/05 90 mcg; Day 180, A/Indonesia/05 90 mcg.
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Biological: A/Indonesia/05/05
Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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9: Experimental
100 subjects: Day 0, A/Vietnam/04 90 mcg; Day 28, A/Vietnam/04 90 mcg.
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Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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8: Experimental
100 subjects: Day 0, A/Vietnam/04 90 mcg.
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Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
|
6: Experimental
50 subjects: Day 0, A/Vietnam/04 90 mcg; Day 180, A/Indonesia/05 90 mcg.
|
Biological: A/Indonesia/05/05
Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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5: Experimental
50 subjects: Day 0, A/Vietnam/04 45 mcg + A/Indonesia/05 45 mcg; Day 28, A/Vietnam/04 45 mcg + A/Indonesia/05 45 mcg.
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Biological: A/Indonesia/05/05
Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
|
4: Experimental
50 subjects: Day 0, A/Vietnam/04 90 mcg; Day 28, A/Indonesia/05 90 mcg.
|
Biological: A/Indonesia/05/05
Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
Biological: A/Vietnam/1203/04
Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine; dosages 45 mcg and 90 mcg.
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Severe disease in humans due to avian influenza viruses of the H5N1 subtype has raised concern regarding the potential emergence of these viruses in pandemic form. Results of earlier studies suggest that previous priming can significantly affect the responses to subsequent booster doses, even if these booster doses represent an antigenic variant. Both the length of time between priming and revaccination, as well as the antigenic relatedness of the priming and revaccination antigens, may impact the response. Each of these issues could have an important impact on pre-vaccination strategies prior to the emergence of a pandemic. This study will evaluate immunogenicity with the same or with different H5 variants. In this study, "different" will be defined as clade 1 followed by clade 1, clade 1 followed by clade 2, clade 2 followed by clade 2, or a combination of clades 1 and 2 followed by a combination of clades 1 and 2. In addition, the study will evaluate the effect of the interval between doses on the subsequent response, with "ultra-short" intervals defined as 7 or 14 days, a "short" interval defined as 28 days and a "long" interval defined as 180 days. The study will evaluate whether the use of a longer duration between doses or cross-clade priming will result in enhanced immunogenicity. Primary objectives of the study are to: evaluate the dose and schedules of unadjuvanted inactivated subvirion H5N1 vaccines belonging to the same or different clades in H5-naïve, healthy adults; determine if boosting of subjects given the inactivated influenza rg A/Vietnam/1203/04 vaccine with a heterologous antigen inactivated influenza rg A/Indonesia/05/05 results in broader or higher immune responses compared with boosting with the homologous antigen; and evaluate the immune response to 2 doses of H5 vaccine given at times less than 1 month apart. Secondary objectives of the study are to: determine the safety of 2 doses of inactivated H5 vaccines in healthy adults given at different schedules and antigen combinations; obtain additional information regarding the antibody response to a single dose and to ultra-short immunization schedules; and evaluate the effect on antibody levels after receiving an antigenic variant to the priming virus given as a booster or simultaneously. The study will be conducted as a randomized, prospective controlled, multi-center trial. Approximately 500 healthy adult subjects, aged 18 through 49, who have no history of prior H5 influenza exposure or vaccination will be enrolled in this study. Subjects will be randomized to receive varying schedules, (2 doses separated by 7, 14, 28 or 180 days), and clades of unadjuvanted inactivated subvirion H5N1 vaccine. The primary endpoint is the geometric mean titer (GMT), frequency of 4-fold or greater antibody titer increases, and proportion of subjects achieving a serum hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against the 2 antigens being evaluated, 1 month post dose 2 vaccination. The secondary endpoints include: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments); GMT, frequency of 4-fold or greater increases and proportion of subjects achieving a titer of 1:40 or greater in neutralizing antibody titers against the 2 antigens being evaluated, 1 month post dose 2 vaccination; development of serum HAI and neutralizing antibody responses against the A/Vietnam/1203/04 virus after 2 vaccinations of A/Indonesia/05/05 vaccine; GMT of antibody at 6 months post dose 2; kinetics and magnitude of antibody development by HAI and neutralizing antibody after the ultra-short immunization schedules versus standard 2 dose schedule; and explore the antibody responses by HAI and neutralizing antibody to other H5 hemagglutinin variants after vaccination with various schedules and combination of A/Vietnam/1203/04 and/or A/Indonesia/05/05.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
The Hope Clinic of the Emory Vaccine Center | |
Decatur, Georgia, United States, 30030 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Saint Louis University | |
St. Louis, Missouri, United States, 63104 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98122 | |
Group Health Cooperative Center for Health Studies | |
Seattle, Washington, United States, 98101 |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 07-0019 |
Study First Received: | June 19, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00703053 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
Influenza, H5N1, vaccine, avian influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
RNA Virus Infections |