A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza

NCT00440362 | Completed Phase 1 DMC

• 1 other identifier: AVX502-002
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers 18-40 years of age. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on one or two occasions over 2 months. The study will last 4 months and will have a total of 8 visits.

Conditions

Influenza

Keywords

Influenza; Flu; A/Wyoming/03/2003; Alphavirus

Outcome Measures

Primary Outcomes (1)

• Evaluate safety of AVX502 in healthy volunteers via frequency of Grade 2-4 systemic reactogenicity events, grade 3 or 4 local vaccine reactions and all AE's

  16 weeks

Secondary Outcomes (1)

• Evaluate immunogenicity of AVX502 in healthy volunteers via serum antibody concentration

  4 weeks post first dose of vaccine

Study Arms (12)

T1

ACTIVE COMPARATOR

Biological: AVX502

T2

ACTIVE COMPARATOR

Biological: AVX502

T3

ACTIVE COMPARATOR

Biological: AVX502

T4

ACTIVE COMPARATOR

Biological: AVX502

T5

ACTIVE COMPARATOR

Biological: AVX502

T6

ACTIVE COMPARATOR

Biological: AVX502

T7

ACTIVE COMPARATOR

Biological: AVX502

T8

ACTIVE COMPARATOR

Biological: AVX502

C1

PLACEBO COMPARATOR

Biological: Placebo

C2

PLACEBO COMPARATOR

Biological: Placebo

C3

PLACEBO COMPARATOR

Biological: Placebo

C4

PLACEBO COMPARATOR

Biological: Placebo

Interventions

AVX502 BIOLOGICAL

1 dose at 2e8 IU given at t=0 via IM route

T2

Placebo BIOLOGICAL

1 dose of placebo given at T=0 via the IM route

C1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 40 years of age, inclusive;
• Good general health without significant physical examination findings or clinically significant abnormal laboratory results;
• Available to participate for the entire study period of approximately 4 months;
• For women of childbearing potential, a negative urine pregnancy test at screening and before each immunization, and agreement to consistently use contraception from 28 days prior to enrollment until the last protocol visit, for sexual activity that could lead to pregnancy;
• Acceptable laboratory parameters: hemoglobin ≥ 11.2 g/dL for women, ≥ 12.8 g/dL for men, white blood cell count 3,300 - 12,000 cells/mm3, platelet count 125,000 - 550,000/mm3, alanine aminotransferase (ALT) within normal range for study laboratory, serum creatinine within normal range for study laboratory, normal urine dipstick (negative glucose, negative hemoglobin, and negative or trace protein), negative hepatitis B virus (HBV) and hepatitis C virus (HCV) blood tests, negative HIV blood test;
• Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
• Willingness to participate in the study as evidenced by signed informed consent obtained before screening.

You may not qualify if:

• Venous access deemed inadequate for the phlebotomy demands of the study;
• Women who are breast feeding;
• In female subjects, a positive urine pregnancy test at screening or on the day of any vaccine injection;
• Receipt of any influenza vaccine within 12 months prior to enrollment;
• Receipt of any other vaccine within 30 days prior to enrollment;
• Use of any investigational agent within 30 days prior to enrollment;
• Receipt of immunoglobulin or blood products within 60 days prior to enrollment;
• Use of cytotoxic medications within 6 months prior to enrollment;
• Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment);
• Presence of any factor that places the individual at increased risk for severe complications from influenza;
• History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain;
• History of autoimmune disease;
• History of splenectomy;
• History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment);
• Psychiatric condition that may interfere with the ability to comply with the protocol requirements. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years;

Sponsors & Collaborators

• AlphaVax, Inc.: lead

Study Sites (1)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Related Links

• AlphaVax, Inc.
• Johnson County Clin-Trials

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert A Olmsted, Ph.D.

  AlphaVax, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 10, 2008

Record last verified: 2008-11

Locations

US (1)