Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Rochester.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01023711
First received: December 1, 2009
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.


Condition Intervention
Influenza
Biological: Inactivated H1N1 vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Effect of Age and Priming on the Immunological Response to an Inactivated Vaccine for Novel H1N1 Virus.

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • determination of immune response to vaccination will be the development of the serum antibody assessed by hemagglutination-inhibition (HAI) and neutralization tests [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assessment of the safety of vaccination will be the rate and severity of solicited adverse events within seven days of vaccine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
H1N1 Vaccine
0.5 mL IM
Biological: Inactivated H1N1 vaccine
0.5 ml IM into Deltoid region of arm
Other Name: Influenza A (H1 N1) 2009 Monovalent Vaccine
Biological: Inactivated H1N1 vaccine
0.5 mL IM X 1 dose
Other Name: Swine Flu Vaccine

Detailed Description:

Studies have now determined that only a single dose of inactivated vaccine is needed for immunization against novel H1N1, but the reasons why adults appear to be ready to respond to a single dose are not known.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18-32 years, or 60 years and older
  • No history of Novel H1N1 virus or vaccine
  • Female not able to bear children or not pregnant and agrees to practice effective birth control
  • Female negative pregnancy test
  • Good Health
  • Ability to understand and comply with protocol
  • Provided Informed Consent

Exclusion Criteria:

  • Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
  • Previous history of vaccination with A/New Jersey/76 vaccine (for subjects 60 & older
  • History of egg allergy or is allergic to other components of the vaccine
  • Women who are pregnant or breastfeeding or intends to get pregnant during the study period between enrollment & 30 days following vaccination
  • Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy/radiation therapy in the preceding 36 months
  • Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. "Active" is defined as treatment within the past 5 years.
  • Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal & topical steroids allowed)
  • Received immunoglobulin or other blood product within 3 months prior to enrollment in this study
  • Subject has received an inactivated vaccine within 2 weeks or a live vaccine within 4 weeks prior to enrollment or plans to receive another vaccine within the next 28 days
  • Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. Those conditions include chronic conditions recognized as risk factors for influenza complications or as contraindicated for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment
  • Subject has an acute illness or an oral temperature greater then 99.9 F(37.7 C)within 3 days of enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete & symptoms resolved > 3 days prior to enrollment.
  • Subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month of enrollment in this study, or intends to donate blood during this period.
  • Subject has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  • Subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or are receiving psychiatric drugs. Subjects who are receiving a single anti-depressant drug & are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
  • Subject has a history of alcohol or drug abuse in the 5 years of enrollment.
  • Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt of influenza vaccine
  • Subject has any condition that the principal investigator (PI) believes may interfere with the successful completion of 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: NCT01023711

Locations
United States, New York
Vaccine Research Unit Room 3-5000
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: John J. Treanor, M.D. University of Rochester
  More Information

No publications provided

Responsible Party: John Treanor, M.D., University of Rochester
ClinicalTrials.gov Identifier: NCT01023711     History of Changes
Other Study ID Numbers: URMC 09-005
Study First Received: December 1, 2009
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Influenza

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 July 22, 2014