Full Text View
Tabular View
No Study Results Posted
Related Studies
CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
This study is ongoing, but not recruiting participants.
First Received: July 21, 2009   Last Updated: September 3, 2009   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943488
  Purpose

The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle.

Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection.

Participants will be involved in study related procedures for approximately 7 months.


Condition Intervention Phase
Influenza
Biological: Inactivated H1N1 Vaccine
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of an Unadjuvanted CSL H1N1 Influenza Vaccine Administered at Two Dose Levels

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety: occurrence of solicited local and systemic adverse events (AEs). [ Time Frame: Within 8 days post vaccination (Day 0-7). ] [ Designated as safety issue: Yes ]
  • Safety: occurrence of vaccine-associated serious adverse events (SAEs). [ Time Frame: Throughout the course of the study. ] [ Designated as safety issue: Yes ]
  • Proportion of subjects, stratified by age, with 4-fold or greater HAI antibody titer increases against influenza H1N1 2009 virus following 1 dose of vaccine. [ Time Frame: Day 8-10 after vaccination and Day 21. ] [ Designated as safety issue: No ]
  • Proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater against influenza H1N1 2009 virus following 1 dose of H1N1 vaccine. [ Time Frame: Day 8-10 after vaccination and Day 21. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater against influenza H1N1 2009 virus following 2 doses of H1N1 vaccine. [ Time Frame: Day 30 and Day 42. ] [ Designated as safety issue: No ]
  • Proportion of subjects, stratified by age, with 4-fold or greater HAI antibody titer increases against influenza H1N1 2009 virus following 2 doses of H1N1 vaccine. [ Time Frame: Day 30 and Day 42. ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: August 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: H1N1 Vaccine 15 mcg: Experimental
200 subjects (100 subjects ages 18-64 and 100 subjects greater than or equal to age 65) to receive 15 mcg of H1N1 vaccine on Days 0 and 21.
Biological: Inactivated H1N1 Vaccine
Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.
Group 2: H1N1 Vaccine 30 mcg: Experimental
200 subjects (100 subjects ages 18-64 and 100 subjects greater than or equal to age 65) to receive 30 mcg of H1N1 vaccine on Days 0 and 21.
Biological: Inactivated H1N1 Vaccine
Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.

Detailed Description:

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Data from several cohorts in different age groups that received licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide protection against the new virus. In addition, adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. These data indicate the need to develop vaccines against the new H1N1 strain and suggest that different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate for persons in different age groups. The primary safety objective of this study is to assess the safety of the unadjuvanted, inactivated H1N1 vaccine when administered at the 15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following a single dose of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose. The secondary immunogenicity objective is to assess the antibody response following 2 doses of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose. Participants will include up to 450 healthy adults age 18 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine at 2 dose levels. Subjects will be randomized into 2 dose groups, stratified by age (200 subjects per dose group with 100 subjects per age stratum, 18-64 or greater than or equal to 65 years of age) to receive intramuscular inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). The H1N1 vaccine will be administered at Day 0 and Day 21.

Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses and Day 21 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination (Day 201), and reactogenicity to the vaccine for 8 days following each vaccination (Day 0-7). Immunogenicity testing will include HAI and neutralizing antibody testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 8-10 after each vaccination, and 21 days following the second vaccination (Day 42).

  Eligibility

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

Inclusion Criteria:

  • Are males or non-pregnant females age 18 and older, inclusive.
  • Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
  • Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. (A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion).
  • Are able to understand and comply with planned study procedures.
  • Provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  • Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).
  • Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
  • Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
  • Have an active neoplastic disease or a history of any hematologic malignancy.
  • Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
  • Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
  • Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
  • Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
  • Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
  • Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).
  • Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.

This is inclusive of seasonal influenza vaccines.

  • Have 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.
  • Have a history of severe reactions following previous immunization with influenza virus vaccines.
  • Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
  • Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
  • Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have history of novel influenza H1N1 2009 infection or treatment.
  • Have a known active Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection.
  • Have a history of alcohol or drug abuse in the last 5 years.
  • Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination.
  • Have a history of Guillain-Barré Syndrome.
  • Have any condition that the investigator believes may interfere with successful completion of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943488

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Washington
Group Health Cooperative Center for Health Studies
Seattle, Washington, United States, 98101
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: HHS/NIAID/DMID ( Robert Johnson )
Study ID Numbers: 09-0043
Study First Received: July 21, 2009
Last Updated: September 3, 2009
ClinicalTrials.gov Identifier: NCT00943488     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
influenza A viruses, H1N1, elderly

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on September 11, 2009