Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants - Full Text View

Purpose

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	Intervention
Immunocompromised Patients Safety of Pandemic Influenza A (H1N1)Vaccine Immunogenicity of Pandemic Influenza A (H1N1)Vaccine	Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by Butantan Institute:

Primary Outcome Measures:

Antibody titers of 1:40 or more for influenza A pandemic (H1N1) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay

Secondary Outcome Measures:

Safety of the vaccine [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: Yes ]
Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination

Enrollment:	1152
Study Start Date:	April 2010
Study Completion Date:	April 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	6 Months to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Volunteers with chronic and or immunocompromised disease, elderly and pregnant in follow - up at the institutions participants in the study will be recruited.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218685

Locations

Brazil
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

More Information

No publications provided by Butantan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miraglia JL, Abdala E, Hoff PM, Luiz AM, Oliveira DS, Saad CG, Laurindo IM, Viso AT, Tayra A, Pierrotti LC, Azevedo LS, Campos LM, Aikawa NE, Timenetsky Mdo C, Luna E, Cardoso MR, Guedes Jda S, Raw I, Kalil J, Precioso AR. Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients. PLoS One. 2011;6(11):e27214. Epub 2011 Nov 8.

Responsible Party:	Butantan Institute
ClinicalTrials.gov Identifier:	NCT01218685 History of Changes
Other Study ID Numbers:	BUTVAC-Influenza A (H1N1) 2.0
Study First Received:	October 8, 2010
Last Updated:	February 5, 2013
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Butantan Institute:

Immunocompromised patients
Safety of pandemic influenza A (H1N1)vaccine
Immunogenicity of pandemic influenza A (H1N1)vaccine

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013