Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants
Study Details
Study Description
Brief Summary
The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Health adults
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Health children
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Pregnants
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Elderly over 65 years old
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| HIV patients
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Kidney transplant
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Oncologic patients
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Rheumatologic adult patients
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
| Rheumatologic children patients
|
Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
|
Outcome Measures
Primary Outcome Measures
- Antibody titers of 1:40 or more for influenza A pandemic (H1N1) [21 days after vaccination]
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
Secondary Outcome Measures
- Safety of the vaccine [21 days after vaccination]
Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
- Volunteers able to understand and agree to participate in the study.
Exclusion Criteria:
-
Have egg allergy
-
Have past history of allergy to seasonal influenza vaccine
-
Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
-
Acute infectious disease during seven days prior vaccination
-
Confirmed prior infection by pandemic influenza A (H1N1)
-
Have participated in another clinical trial in the last 6 months
-
Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Avenida Vital Brasil 1500 | Sao Paulo | Brazil | 05503-900 |
Sponsors and Collaborators
- Butantan Institute
- University of Sao Paulo
- Insituto Adolfo Lutz
- Centro de Referencia e Treinamento em DST/AIDS
Investigators
- Study Chair: Alexander Roberto Precioso, MD, PhD, Butantan Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BUTVAC-Influenza A (H1N1) 2.0