Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

Assessment of the Effect of Age and Priming on the Immunological Response to an Inactivated Vaccine for Novel H1N1 Virus.

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Inactivated H1N1 vaccine; Biological: Inactivated H1N1 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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Vaccine Research Unit Room 3-5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inactivated H1N1 Vaccine; Subject will recieve 0.5 mL IM injection of Inactivated H1N1 vaccine	Biological: Inactivated H1N1 vaccine; 0.5 ml IM into Deltoid region of arm; Other Names: Influenza A (H1 N1) 2009 Monovalent Vaccine; Biological: Inactivated H1N1 vaccine; 0.5 mL IM X 1 dose; Other Names: Swine Flu Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Immune Response to Vaccination.	Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Reactogenicity Events Post Vaccination.	Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination	7 days

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: John J. Treanor, M.D., University of Rochester

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: URMC 09-005