Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
This study has been completed.
Sponsor:
Butantan Institute
Collaborators:
Hospital Universitario da USP
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT01111968
First received: April 14, 2010
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: pandemic vaccine 1 Biological: pandemic vaccine 2 Biological: pandemic vaccine 5 Biological: pandemic vaccine 6 Biological: pandemic vaccine 9 Biological: pandemic vaccine 10 Biological: pandmeic vaccine 11 Biological: pandmeic vaccine 12 Biological: pandmic vaccine 13 Biological: placebo group 14 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1) |
Resource links provided by NLM:
Further study details as provided by Butantan Institute:
Primary Outcome Measures:
- the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]Volunteers will receive two doses of vaccine,21 days apart.
Secondary Outcome Measures:
- Safety and tolerability [ Time Frame: 30 minutes and 72 hours after vaccination ] [ Designated as safety issue: Yes ]Evaluation of local and systemic adverse effects throught the study period
| Enrollment: | 266 |
| Study Start Date: | January 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
|
Biological: pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Other Name: vaccine group C
|
|
Experimental: pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
|
Biological: pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
Other Name: vaccine group I
|
|
Experimental: pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
|
Biological: pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Other Name: vaccine group N
|
|
Experimental: pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
|
Biological: pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group A
|
|
Experimental: pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
|
Biological: pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group F
|
|
Experimental: pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
|
Biological: pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
Other Name: vaccine group L
|
|
Experimental: pandemic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
|
Biological: pandmeic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
Other Name: vaccine group E
|
|
Experimental: pandemic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
|
Biological: pandmeic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
Other Name: vaccine group K
|
|
Experimental: pandemic vaccine 13
15µg of A/H1N1 with no adjuvant
|
Biological: pandmic vaccine 13
15µg of A/H1N1 with no adjuvant
Other Name: vaccine group H
|
|
Placebo Comparator: placebo group 14
placebo
|
Biological: placebo group 14
All elements of the vaccine but antigen and adjuvant
Other Name: vaccine group B
|
Detailed Description:
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Health adults of both genders
- Age ≥ 18 ≤ 50 years
- Able to understand every required study procedure
- Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
- Normal values for pre-stablished laboratory assays
- Accpetance to participate and sign the consent form
Exclusion Criteria:
- Any chronic condition
- Be on immunossupressive or stimulant therapy
- Have egg alergy
- Have past history of alergy to sazonal influenza vaccine
- Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
- Acute infectious disease during seven days prior vaccination
- Female on breasthfeeding
- Confirmed prior infection by pandemic influenza A
- Participation in another clinical trial in the last 6 months
- Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111968
Locations
| Brazil | |
| Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP | |
| Sao Paulo, Brazil, 05403-900 | |
| Centro de Pesquisa Clínica do Hospital Universitário da USP | |
| Sao Paulo, Brazil, 05508000 | |
Sponsors and Collaborators
Butantan Institute
Hospital Universitario da USP
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da USP
Investigators
| Principal Investigator: | Lucia MA Campos, MD. PhD | Children´s Institute - School of Medicine of University of Sao Paulo |
More Information
No publications provided by Butantan Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Butantan Institute |
| ClinicalTrials.gov Identifier: | NCT01111968 History of Changes |
| Other Study ID Numbers: | BUTVAC - Influenza A (H1N1) |
| Study First Received: | April 14, 2010 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Butantan Institute:
|
vaccine pandemic influenza A adjuvant safety |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013