H5N1 Vaccine Intramuscular Versus Intradermal in Healthy Adults

May 30, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized, Open-Label, Phase I Clinical Trial Comparing the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults

The purpose of this research study is to compare how the body reacts to different strengths of an H5N1 flu vaccine when given by different routes of injection (injection into the skin or into the muscle). It will also compare how antibodies (proteins produced by the body's immune system that recognize and help fight infections and other foreign substances in the body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid documenting daily oral temperature and side effects for 7 days following each vaccination. Participants may be involved in the study for up to 13 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, randomized, open-label, dose-ranging, phase I comparative trial of intradermal (ID) and intramuscular (IM) injection with subvirion inactivated influenza A/H5N1 vaccine in healthy adults, 18 to 40 years old, inclusive. This study is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine given by ID injection compared to IM injection. The primary objectives of this study are to: compare dose-related safety and reactogenicity profiles of ID and IM injection with subvirion inactivated influenza A/H5N1 vaccine among healthy young adults; compare the dose-related immunogenicity of subvirion inactivated influenza A/H5N1 vaccine given by ID with vaccine given by IM injection among healthy young adults 1 month after receipt of the second dose of vaccine; and provide information for the selection of the best dose levels for further studies. The secondary objectives of this study are to: evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination; and evaluate the dose-related safety, reactogenicity and immunogenicity following receipt of a third dose of vaccine administered 6-7 months after the second dose of vaccine. The study will have 2 comparison arms (IM and ID), and 2 dosage levels will be evaluated in each arm (4 vaccine groups total). Subjects will be randomized 1:1:1:1 (25 subjects in each group) to receive 2 doses 1 month apart of an inactivated influenza A/H5N1 vaccine containing 15 mcg or 45 mcg of H5 HA by the IM route; or one-fifth of the IM dose (3 mcg or 9 mcg) by the ID route. Subjects will maintain a memory aid recording oral temperature, and systemic and local adverse events for 7 days after each inoculation. Serum for immunogenicity evaluations will be obtained prior to first vaccination, at Day 0, prior to second vaccination, at Day 28, and on Day 56 and approximately Day 215 (7 months) after dose 1. This study is linked to DMID protocol 07-0022.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive.
  • Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for at least 3 months after receipt of dose 2 (or dose 3, if applicable).
  • Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
  • Able to understand and comply with planned study procedures.
  • Provides informed consent prior to any study procedures and is available for all study visits.
  • Is not receiving any regular medications with the exceptions of birth control pills and vitamins.
  • Meets all other inclusion criteria and must have received two doses of inactivated influenza A/H5N1 vaccine in the present study to be eligible for a third dose.

Exclusion Criteria:

  • Has a known allergy to eggs or other components of the vaccine.
  • Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is lactating, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
  • Is undergoing immunosuppression as a result of an underlying illness or treatment.
  • Has an active neoplastic disease or a history of any hematologic malignancy.
  • Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
  • Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  • Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • 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 (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
  • Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
  • Has an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
  • Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to each vaccination in the study, or expects to receive an experimental agent within 1 month after each vaccination in the study.
  • Prior receipt of influenza A/H5N1 vaccine, other than the present study.
  • Is enrolled or planning to enroll in another interventional trial at any time between receipt of the third dose of vaccine and the end of the study (approximately 6 months after receipt of the third dose).
  • Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ID injection-9 mcg
25 subjects to receive 9 mcg of inactivated influenza A/H5N1 vaccine intradermally on Days 0 and 28.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
Experimental: IM injection-15 mcg
25 subjects to receive 15 mcg of inactivated influenza A/H5N1 vaccine intramuscularly on Days 0 and 28.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
Experimental: IM injection-45 mcg
25 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine intramuscularly on Days 0 and 28.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
Experimental: ID injection-3 mcg
25 subjects to receive 3 mcg of inactivated influenza A/H5N1 vaccine intradermally on Days 0 and 28.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
Biological: Inactivated Influenza A Vaccine A/H5N1
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects in each vaccine group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Time Frame: Day 56.
Day 56.
Geometric mean titer (GMT) and proportion of subjects achieving a 4-fold or greater increase in serum neutralizing or hemagglutination inhibition (HAI) antibody titer in each group.
Time Frame: Day 56.
Day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessments).
Time Frame: Duration of study.
Duration of study.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Geometric mean titer (GMT) and proportion of subjects achieving a 4-fold or greater increase in neutralizing antibody titers in each group 1 and 7 months after receipt of dose 1.
Time Frame: Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
GMT and the proportion of subjects achieving a 4-fold or greater increase in HAI and neutralizing antibody titers in each group 1 month after receipt of a 3rd dose of vaccine administered approximately 6-7 months after the 2nd dose of vaccine.
Time Frame: Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Development of serum antibody responses against antigenically drifted variants of H5 influenza virus.
Time Frame: Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Geometric mean titer (GMT) and proportion of subjects achieving a 4-fold or greater increase in HAI and neutralizing antibody titers in each group 1 and 7 months after receipt of dose 1.
Time Frame: Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.
Blood samples for serum assays will be collected prior to first dose on day 0, prior to second dose on day 28, and on days 56 and 215 after the first immunization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05-0015

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