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

NCT01031719 | Completed Phase 3

• 1 other identifier: V111_15TP
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

H1N1 Influenza Virus; Invasive Solid Tumors

Keywords

Influenza A Virus; Virus Diseases; Influenza, Human; H1N1; Immunogenicity; safety; tolerability; tumors; oncology

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors

  3 months

Secondary Outcomes (4)

• Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population

  3 months

• Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose

  3 months

• Assess the persistence of antibody levels in the two vaccine groups

  3 months

• Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population

  3 months

Study Arms (4)

Group A: High Risk Population

EXPERIMENTAL

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

Group B: High Risk Subjects

EXPERIMENTAL

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

Group C: Healthy Subjects

EXPERIMENTAL

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

Group D: Healthy Subjects

EXPERIMENTAL

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

Interventions

adjuvanted A(H1N1) influenza vaccine BIOLOGICAL

7.5 ug of HA antigen; adjuvanted; monovalent

Group A: High Risk Population; Group C: Healthy Subjects

non-adjuvanted A(H1N1) influenza vaccine BIOLOGICAL

15ug of HA antigen, non-adjuvanted; trivalent

Group B: High Risk Subjects

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
• Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
• Intra-uterine device (IUD)
• 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

You may not qualify if:

• For Invasive Solid Tumor Subjects:
• Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
• 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
• 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
• For Healthy Subjects:
• Previous laboratory confirmed diagnosis of an infection by the new virus H1N1
• 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)

Sponsors & Collaborators

• Chiltern Pesquisa Clinica Ltda: lead

Study Sites (3)

BIOCANCER Clinical Research

Belo Horizonte, Minas Gerais, Brazil

Location

Centro de Estudos e Pesquisas de Oncologia e Hematologia da Faculdade de Medicina da Fundação do ABC

Santo André, São Paulo, Brazil

Location

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (4)

• Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.

  PMID: 19745215 BACKGROUND

• Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.

  PMID: 19423869 BACKGROUND

• Gross PA, Gould AL, Brown AE. Effect of cancer chemotherapy on the immune response to influenza virus vaccine: review of published studies. Rev Infect Dis. 1985 Sep-Oct;7(5):613-8. doi: 10.1093/clinids/7.5.613.

  PMID: 3903940 BACKGROUND

• Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.

  PMID: 19628174 BACKGROUND

MeSH Terms

Conditions

Virus Diseases; Influenza, Human; Neoplasms

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

BR (3)