Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine

This study has been completed.
Sponsor:
Collaborators:
Institute of Vaccines and Medical Biologicals (IVAC)
Pasteur Institute, Ho Chi Minh City
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01507779
First received: January 6, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)-—each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus-—will be safe and immunogenic in healthy adults.


Condition Intervention Phase
Influenza
Biological: IVACFLU
Other: PBS (Phosphate buffered saline)
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 The Safety and Immunogenicity of an Influenza A/H1N1 Vaccine (IVACFLU), Produced by IVAC, in Healthy Adults in Vietnam

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Safety Profile [ Time Frame: within three weeks after each dose ] [ Designated as safety issue: Yes ]
    Immediate reactions occurring within 60 minutes of administration; solicited and unsolicited adverse events occurring through 7 days following any dose; all serious adverse events (SAEs) occurring within 3 weeks of receipt of any dose

  • Long terms SAEs [ Time Frame: from 3 weeks to 6 months post-dose 2 ] [ Designated as safety issue: Yes ]
    Serious adverse events


Secondary Outcome Measures:
  • Immunogenicity measure 1 [ Time Frame: three weeks after each dose ] [ Designated as safety issue: No ]
    serum hemagglutination-inhibition antibodies

  • Immunogenicity measure 2 [ Time Frame: three weeks after each dose ] [ Designated as safety issue: No ]
    serum neutralizing antibodies using microneutralization assay


Enrollment: 48
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine Biological: IVACFLU
IVACFLU is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose
Other Name: whole virion monovalent A/H1N1 influenza vaccine
Placebo Comparator: Placebo Other: PBS (Phosphate buffered saline)
Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female adult 18 (age of legal consent in Vietnam) through 40 years of age at the enrollment visit.
  • Literate and willing to provide written informed consent.
  • Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
  • Capable and willing to complete diary cards and willing to return for all follow-up visits
  • For females, willing to utilize reliable birth control measures (intrauterine device, birth control pills, condoms) through the Day 42 visit.

Exclusion Criteria:

  • Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
  • Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 42 visit.
  • Current or recent (within two weeks of enrollment) acute illness with or without fever.
  • Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 42 visit.
  • Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, >=0.5 mg per kg per day; topical steroids are allowed.)
  • History of asthma.
  • Hypersensitivity after previous administration of any vaccine.
  • Other AE following immunization, at least possibly related to previous receipt of any vaccine.
  • Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
  • Known hypersensitivities (allergies) to food or the natural environment.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives..
  • History of leukemia or any other blood or solid organ cancer.
  • History of thrombocytopenic purpura or known bleeding disorder.
  • History of seizures.
  • Known or suspected immunosuppressed or immunodeficient condition of any kind, including HIV infection.
  • Known chronic HBV or HCV infection.
  • Known active tuberculosis or symptoms of active tuberculosis, regardless of cause.
  • History of chronic alcohol abuse and/or illegal drug use.
  • Pregnancy or lactation. (A negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential.)
  • History of Guillain-Barre' Syndrome
  • Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
  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: NCT01507779

Locations
Vietnam
Ben Luc Health Center
Ben Luc, Long An, Vietnam
Sponsors and Collaborators
PATH
Institute of Vaccines and Medical Biologicals (IVAC)
Pasteur Institute, Ho Chi Minh City
Investigators
Study Director: Kathleen M Neuzil, MD, MPH PATH
Study Director: Le V Be, MD, PhD Institute of Vaccines and Medical Biologicals (IVAC)
Principal Investigator: Ho V Thang, MD, MSc Pasteur Institute
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01507779     History of Changes
Other Study ID Numbers: IVAC-mH1N1-01
Study First Received: January 6, 2012
Last Updated: September 19, 2013
Health Authority: Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014