Phase I Safety Study of a Recombinant MVA HIV Multiantigen Vaccine in HIV-infected Subjects

NCT00623259 | Completed Phase 1 DMC

• 1 other identifier: HIV-MAG-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine will be administered subcutaneously.

Conditions

HIV Infections

Study Arms (1)

1

EXPERIMENTAL

Biological: MVA-mBN120B

Interventions

MVA-mBN120B BIOLOGICAL

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged between 18 to 55 years.
• HIV-1 infection documented by either plasma HIV-1 RT-PCR or bDNA assay at any time prior to study entry.
• Stable on HAART with regard to immunologic and clinical parameters for at least 6 consecutive months prior to study entry (substitutions of one drug for another in the same class due to reasons other than virologic failure are allowed).
• Plasma HIV RNA level \< 50 copies/ml for at least 6 months prior to study entry; single blips of up to 400 HIV-1 RNA copies/ml are acceptable if they resolve spontaneously without a change in HAART.
• Plasma HIV-1 RNA levels of \< 50 copies/ml at study entry.
• Women with childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to immunization.
• Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first immunization, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last immunization. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
• CD4 cells ≥ 350/µl (two determinations, of which one must be done during the screening and the other must be done within 3 months before study entry)
• CD4 nadir \> 150/µl.
• Troponin I within normal institutional limits.
• White blood cells ≥ 2500/mm3 and \< = 11,000/ mm3.
• Negative urine glucose by dipstick or urinalysis at screening.
• Haemoglobin ≥ 9.0g/dL.
• Platelets ≥ 100,000/mm3
• Adequate renal function defined as:

You may not qualify if:

• Pregnant or breast-feeding women.
• Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
• History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
• History of suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement therapy are not excluded.
• History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 months).
• History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
• Manifestation of clinically significant and severe haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorder.
• Clinically significant mental disorder not adequately controlled by medical treatment.
• Any condition which might interfere with study objectives or would limit the subject's ability to complete the study or to be compliant in the opinion of the investigator.
• History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
• History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
• Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Known allergy to egg or aminoglycoside (gentamicin).
• History of anaphylaxis or severe allergic reaction.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: DIAGNOSTIC
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 26, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 20, 2010

Record last verified: 2010-05

Locations

US (1)