A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)

NCT00439803 | Completed Phase 1 DMC

• 1 other identifier: AVX601-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and IE1) is a candidate vaccine against cytomegalovirus (CMV). 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 who have not previously been infected with CMV. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on three occasions over 6 months. The study will last 12 months and will have a total of 12 visits.

Conditions

Cytomegalovirus Infections

Keywords

CMV; cytomegalovirus; Alphavirus

Outcome Measures

Primary Outcomes (1)

• evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events

  1 year

Secondary Outcomes (1)

• evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine

  15 months

Study Arms (8)

T1

ACTIVE COMPARATOR

Biological: AVX601

C1

PLACEBO COMPARATOR

Biological: Placebo

T2

ACTIVE COMPARATOR

Biological: AVX601

C2

PLACEBO COMPARATOR

Biological: Placebo

T3

ACTIVE COMPARATOR

Biological: AVX601

C3

PLACEBO COMPARATOR

Biological: AVX601

T4

ACTIVE COMPARATOR

Biological: AVX601

C4

PLACEBO COMPARATOR

Biological: Placebo

Interventions

AVX601 BIOLOGICAL

3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route

T1

Placebo BIOLOGICAL

3 doses of placebo given at T=0, 8, 24 weeks via the IM route

C1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 45 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 12 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:
• negative CMV serology
• 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 CMV or the alphavirus vector if such assays become available

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 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)
• History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain
• History of immunodeficiency or autoimmune disease
• History of diabetes mellitus
• 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.
• History of medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months

Sponsors & Collaborators

• AlphaVax, Inc.: lead

Study Sites (1)

Cincinnati Center for Clinical Research

Cincinnati, Ohio, 45229, United States

Location

Related Links

• AlphaVax Human Vaccines, Inc.

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

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 26, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 10, 2008

Record last verified: 2008-11

Locations

US (1)