Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd
ClinicalTrials.gov Identifier:
NCT00915187
First received: June 3, 2009
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).


Condition Intervention Phase
Influenza
Drug: CCS/C
Biological: Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study

Resource links provided by NLM:


Further study details as provided by NasVax Ltd:

Primary Outcome Measures:
  • Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate [ Time Frame: Day 28 following vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate [ Time Frame: Day 90 following vaccination ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Biological: Influenza Vaccine
Influenza vaccine
Experimental: CCS/C (Adjuvant Formulation) Drug: CCS/C
Adjuvant to influenza vaccine

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
  • able to comply with all the study requirements;
  • in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
  • Have adequate renal function (renal clearance of at > 30ml/min)
  • Have normal liver function (hepatic transaminases [ALT and AST] < 43 U/L)
  • Have hemoglobin > 11.5 g/L

Exclusion Criteria:

  • Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
  • Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at < 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
  • Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
  • History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
  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: NCT00915187

Locations
Israel
Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
NasVax Ltd
Investigators
Principal Investigator: Yoseph Caraco, MD Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel
  More Information

No publications provided

Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT00915187     History of Changes
Other Study ID Numbers: NX09-4
Study First Received: June 3, 2009
Last Updated: October 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NasVax Ltd:
Vaccination, influenza prevention

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 October 02, 2014