An Evaluation of Immunogenicity and Safety of Two Doses of MVA-nef vs. MVA-BN in HIV-1 Infected Patients

NCT00189930 | Completed Phase 2

• 2 other identifiers: HIV-NEF-004HHSN266200400072C
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce Nef-specific cellular immune response in HIV-1 infected patients

Conditions

HIV Infection

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)

  52 Weeks

Secondary Outcomes (1)

• Occurrence, intensity and relationship of adverse events occurring at any time during the study

  52 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

High dose

Biological: MVA-nef

2

ACTIVE COMPARATOR

Low dose

Biological: MVA-nef

3

PLACEBO COMPARATOR

Biological: IMVAMUNE

Interventions

MVA-nef BIOLOGICAL

3 imm.: 5E8\_TCID50 MVA-nef, 1E8\_TCID50 MVA-nef in non-dominant upper arm

1; 2

IMVAMUNE BIOLOGICAL

3 immunizations: 1E8\_TCID50 IMVAMUNE

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-60
• HIV-1 infection, as documented by any licensed PCR kit or ELISA (confirmed by an complementary assay e.g. Western blot HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA) at any time prior to study entry.
• Stable on HAART for at least 6 consecutive months prior to study entry (changes of one drug for the another drug due to reasons other than virologic failure are allowed)
• Plasma HIV-1 RNA levels of \< 50 copies/ml for at least 6 months prior to study entry (two single blips of up to 200 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
• CD4 nadir \>100
• CD4+ cell counts \> 250/µl (one measurement within 4 months prior to study entry and one measurement within screening phase)
• For women, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
• If the volunteer is female and of childbearing potential, she agrees to use an acceptable method of contraception, and not become pregnant for at least 56 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) with use of method for a minimum of 30 days prior to vaccination).
• ALT/SGPT, AST/SGOT, and alkaline phosphatase \< 3 times institutional upper limit of normal (ULN).
• Urine protein by dipstick or urinalysis \< 100mg/dl or \<2+ proteinuria
• CBC: Haemoglobin \>8 g/dl; White blood cells greater than 2,500 and less than 11,000/mm3; Platelets greater than or equal to 100,000/mm3
• Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure
• Cardiac enzymes: within normal range.

You may not qualify if:

• Pregnant or breast-feeding women.
• Administration of any HIV nef vaccine or vaccinia immunization within the past 5 years.
• 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 or active autoimmune disease. Persons with vitiligo or thyroid disease on thyroid replacement are not excluded.
• 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.
• History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
• Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator.
• ECG with clinical significance (complete left or right bundle branch block, or sustained ventricular arrythmia, or 2 PVCs in a row, or ST elevation consistent with ischemia).
• History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
• or more of the following risk factors:
• High blood pressure requiring therapy.
• High blood cholesterol (\> 300 mg/dl or ratio LDL/HDL ≥ 3) not induced by the HIV therapy.
• Diabetes mellitus or high blood sugar.
• He/she has a first degree relative (for example mother, father, brother, or sister) who had a heart condition before the age of 50.

Sponsors & Collaborators

• Bavarian Nordic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (5)

University of Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Doctor's Practice

Fürth, Bavaria, 90762, Germany

Location

Doctor's Practice

Munich, Bavaria, 80335, Germany

Location

Doctor's Practice

Munich, Bavaria, 80801, Germany

Location

Doctor's Practice

Nuremberg, Bavaria, 90641, Germany

Location

MeSH Terms

Conditions

HIV Infections

Interventions

MVA-HIV-1 nef vaccine; smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

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 Officials

• Thomas Harrer, MD

  University of Erlangen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2005
• Study Completion: December 1, 2006
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

DE (5)