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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: VAX128; Biological: Placebo

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
• Enrollment (Actual): 292
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Miami Research Associates
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VAX128; Novel H1N1 Influenza vaccine	Biological: VAX128; one IM injection; Other Names: STF2.HA1 CA07
PLACEBO_COMPARATOR: Placebo; one IM injection	Biological: Placebo; One IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	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.	28 days

Collaborators and Investigators

• Sponsor: VaxInnate Corporation

Publications and helpful links

General Publications

• Taylor DN, Treanor JJ, Sheldon EA, Johnson C, Umlauf S, Song L, Kavita U, Liu G, Tussey L, Ozer K, Hofstaetter T, Shaw A. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine. 2012 Aug 24;30(39):5761-9. doi: 10.1016/j.vaccine.2012.06.086. Epub 2012 Jul 11.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (ESTIMATE): July 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: influenza vaccine recombinant
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VAX128-01