Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults

NCT00921206 | Completed Phase 1

• 1 other identifier: VAX102-05
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.

Conditions

Influenza

Keywords

influenza; influenza vaccine; universal influenza vaccine; Matrix 2e protein; M2e; Immune response

Outcome Measures

Primary Outcomes (1)

• To assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.

  2 months

Secondary Outcomes (1)

• To assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.

  2 months

Study Arms (2)

VAX102 given i.m.

ACTIVE COMPARATOR

Universal influenza candidate vaccine

Biological: VAX102

VAX102 given s.c.

ACTIVE COMPARATOR

Universal influenza candidate vaccine

Biological: VAX102

Interventions

VAX102 BIOLOGICAL

1 ug i.m. compared to 2 ug s.c.

Also known as: STF2.4xM2e

VAX102 given i.m.; VAX102 given s.c.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18 - 49 years inclusive
• Give written informed consent to participate.
• Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
• Females willing to practice birth control to avoid pregnancy during the study
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

You may not qualify if:

• Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
• Cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible
• Impaired immune responsiveness (of any cause), including diabetes mellitus.
• Documented influenza infection in the 6 months prior to study entry.
• Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed.
• Receipt or planned administration of a nonstudy vaccine within 30 days before and during the study and through the Day 42 evaluation.
• History of anaphylactic type reaction to injected vaccines.
• History of drug or chemical abuse in the year before the study.
• Use of new prescription medications started within 7 days before study entry.
• Receipt of blood or blood products 8 weeks before study entry or planned administration during the study period.
• Donation of blood or blood products within 8 weeks before study entry or at any time during the study.
• Acute disease within 72 hours prior to vaccinations, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever, or a fever \>37.9ºC orally. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered.
• Any condition that, in the opinion of the investigator, might interfere with study objectives

Sponsors & Collaborators

• VaxInnate Corporation: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Universite of Colorado, Denver

Denver, Colorado, 80045, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Influenza, Human

Interventions

VAX102 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Edward Janoff, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 23, 2014

Record last verified: 2014-09

Locations

US (1)