Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults (VAX128-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172054
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : July 31, 2012
Information provided by (Responsible Party):
VaxInnate Corporation

Brief Summary:
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.

Condition or disease Intervention/treatment Phase
Influenza Biological: VAX128 Biological: Placebo Phase 1

Detailed Description:
VAX128-01 is a first in human study of three inactivated recombinant novel H1N1 influenza vaccines, designated VAX128 A, B and C. The purpose of the study is to compare the safety and immunogenicity of the three vaccines through a range of doses and to select one of the vaccines for further testing in phase II studies. We plan to assess the safety and immunogenicity in a dose escalating study. The study will enroll up to 100 healthy young adults (18-49 years) and 100 healthy adults than age 65 years. We are including the older adults in this phase 1 study because we have found that the elderly tolerated a vaccine similar to one of the candidates, VAX128A, better than young adults, but required a higher vaccine dose to achieve a similar antibody response. Nevertheless, because we are testing two other constructs (VAX128B and C), we will be making the conservative assumptions that the safety and immunogenicity data coming from the young adults will not predict the results in the elderly. Therefore, we will begin the study in the young adults and after the first three dose levels have been tested we will begin testing in the older adults. In this study we plan to enroll up to 100 young adults and up to 100 adults 65 years and older. The young adults will be most likely enrolled at one clinical site and the older adults will be enrolled at another clinical site. We plan to enroll a cohort of 10 young adults and 10 older adults every week. Each cohort will consist of 3 subjects to receive one of the three vaccines (9 subjects total) and one subject in each cohort will receive placebo. Dosing for the next cohort will be based on a two day assessment period after vaccination. The main part of the study will be conducted over 28 days and there will be two follow up phone calls at 6 months and one year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I Escalating Dose Ranging Study to Evaluate the Safety and Immunogenicity of the VAX128 A, B, and C Novel H1N1 Influenza Vaccine Constructs in Healthy Adults 18-49 Years of Age and in Community Living Adults ≥65 Years of Age
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: VAX128
Novel H1N1 Influenza vaccine
Biological: VAX128
one IM injection
Other Name: STF2.HA1 CA07

Placebo Comparator: Placebo
one IM injection
Biological: Placebo
One IM injection

Primary Outcome Measures :
  1. Safety [ Time Frame: 28 days ]
    Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising etc) or systemic (headache, muscle aches, fatigue, etc) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine construct or placebo.

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 28 days ]
    To assess serm immune response, sera collected at Day 0 (pre-vaccination), 7, 14 and 28 will be analyzed for HAI, serum IgG anti-HA by ELISA and serum IgG anti-flagellin by ELISA. The geometric mean, seroconversion and seroprotection rates will be determined.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or female aged 18 - 49 years or >= 65 years
  • Give written informed consent
  • Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
  • Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
  • Willing to provide multiple blood specimens collected by venipuncture

Exclusion Criteria:

  • Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
  • Impaired immune responsiveness
  • Received drugs effecting the immunity
  • Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
  • History of anaphylactic type reaction to injected vaccines.
  • History of drug abuse in the year prior to screening.
  • History of Guillain-Barré Syndrome.
  • Receipt or donation of blood products
  • Acute disease within 72 hours prior to vaccination
  • History of heart or lung disease
  • Has other conditions that might interfere with study objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01172054

United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
VaxInnate Corporation
Study Director: David N Taylor, MD VaxInnate Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VaxInnate Corporation Identifier: NCT01172054     History of Changes
Other Study ID Numbers: VAX128-01
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by VaxInnate Corporation:
influenza vaccine recombinant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs