Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiltern Pesquisa Clinica Ltda
ClinicalTrials.gov Identifier:
NCT01031719
First received: December 14, 2009
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.

Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.


Condition Intervention Phase
H1N1 Influenza Virus
Invasive Solid Tumors
Biological: adjuvanted A(H1N1) influenza vaccine
Biological: non-adjuvanted A(H1N1) influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors

Resource links provided by NLM:


Further study details as provided by Chiltern Pesquisa Clinica Ltda:

Primary Outcome Measures:
  • The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Assess the persistence of antibody levels in the two vaccine groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: High Risk Population
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Biological: adjuvanted A(H1N1) influenza vaccine
7.5 ug of HA antigen; adjuvanted; monovalent
Experimental: Group B: High Risk Subjects
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Biological: non-adjuvanted A(H1N1) influenza vaccine
15ug of HA antigen, non-adjuvanted; trivalent
Experimental: Group C: Healthy Subjects
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Biological: adjuvanted A(H1N1) influenza vaccine
7.5 ug of HA antigen; adjuvanted; monovalent
Experimental: Group D: Healthy Subjects
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
Biological: non-adjuvanted A(H1N1) influenza vaccine
15 mcg of antigen; non-adjuvanted; trivalent

  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Invasive Solid Tumor Subjects:

  • Subjects between 2 and 70 years of age (inclusive)
  • Any sex or ethnicity
  • Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete remission for at least 3 months and not more than 18 months after the last neo-adjuvant and/or adjuvant chemotherapy cycle according to investigators assessment and the subjects medical records
  • Previous use of neo-adjuvant and/or adjuvant chemotherapy for the treatment on an invasive solid tumor
  • Life expectancy of at least 12 months
  • Karnofsky Performance Scale > 40%
  • Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:

    1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
    2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
    3. Intra-uterine device (IUD)
    4. Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study).
  • Subjects capable of following all the study procedures and available for all visits scheduled to the investigation site
  • Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
  • In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form
  • The study subjects may have other underlying chronic diseases that do not involve immunosuppression (e.g. osteoarticular diseases, cardiorespiratory diseases, metabolic diseases, stable, non progressive, non-severe neurologic disorders without cognitive impairment, ophthalmologic diseases, etc.), but their symptoms/signs must be under control through medical follow-ups and drug therapy

For Healthy Subjects:

  • Subjects between 2 and 70 years of age (inclusive)
  • Any sex and ethnicity
  • Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
  • Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:

    1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
    2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole sexual intercourse
    3. Intra-uterine device (IUD)
    4. Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study).
  • Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
  • Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
  • In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form

Exclusion Criteria:

For Invasive Solid Tumor Subjects:

  • Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
  • Administration of other vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
  • Any recent vaccine given within the last 21 days (inclusive)
  • History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
  • Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
  • Presence of other diseases, not related to cancer with confirmed immunosuppression
  • Chemotherapy, biologic therapy or radiation within 3 months prior to inclusion in the study
  • History of chronic hepatic or renal disease
  • History of cognitive disorders
  • History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
  • Pregnancy or breast-feeding
  • Use of immunomodulatory therapy, including cyclosporin, interleukins, and interferons, within 3 months prior to inclusion in the study
  • Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
  • Receipt of any investigational product within 12 months prior to inclusion in the study

For Healthy Subjects:

  • Previous laboratory confirmed diagnosis of an infection by the new virus H1N1
  • Receipt of another vaccine against the new virus H1N1 within 3 months prior to inclusion in the study
  • Any recent vaccine given within the last 21 days (inclusive)
  • History of allergic reaction to influenza vaccine in the past, or a current or previous allergy to egg or egg protein, kanamycin, and neomycin sulfate;
  • Acute febrile disease (the vaccination may be delayed up to 3 days after symptoms resolution)
  • Pregnancy or breast-feeding
  • Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study;
  • Receipt of any investigational product within 12 months prior to inclusion in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031719

Locations
Brazil
BIOCANCER Clinical Research
Belo Horizonte, MG, Brazil
Centro de Estudos e Pesquisas de Oncologia e Hematologia da Faculdade de Medicina da Fundação do ABC
Santo André, SP, Brazil
Universidade Federal de São Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
Chiltern Pesquisa Clinica Ltda
  More Information

Publications:
Responsible Party: Chiltern Pesquisa Clinica Ltda
ClinicalTrials.gov Identifier: NCT01031719     History of Changes
Other Study ID Numbers: V111_15TP
Study First Received: December 14, 2009
Last Updated: September 12, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Chiltern Pesquisa Clinica Ltda:
Influenza A Virus
Virus Diseases
Influenza, Human
H1N1
Immunogenicity
safety
tolerability
tumors
oncology

Additional relevant MeSH terms:
Influenza, Human
Neoplasms
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014