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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
MVA-nef
IMVAMUNE
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Treatment Experienced

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 3 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. Smoking cigarettes now. History of chronic alcohol abuse (40g / day for at least 6 month) and/or intravenous drug abuse (within the past 6 month). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. History of anaphylaxis or severe allergic reaction. Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment. Any vaccinations with active vaccines within a period starting 30 days prior to administration of the vaccine and ending 30 days after administration of the study vaccine. Any vaccinations with inactive vaccines within a period starting 14 days prior to administration of the vaccine and ending 14 days after administration of the study vaccine. Chronic administration (defined as more than 14 days) of immuno- suppressant or immune-modifying drugs during the study period (Corticosteroid nasal sprays are permissible. Subjects who have used topical and inhaled steroids can be enrolled after their therapy is completed). Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is longer) preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.

Sites / Locations

  • University of Erlangen
  • Doctor's Practice
  • Doctor's Practice
  • Doctor's Practice
  • Doctor's Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

High dose

Low dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
September 28, 2012
Sponsor
Bavarian Nordic
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00189930
Brief Title
An Evaluation of Immunogenicity and Safety of Two Doses of MVA-nef vs. MVA-BN in HIV-1 Infected Patients
Official Title
A Single-blind, Randomized, Controlled, Phase II Study to Evaluate Immunogenicity and Safety of Two Doses of the MVA-nef HIV Vaccine in HIV-1 Infected Patients With CD4 > 250/µl
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bavarian Nordic
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
High dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low dose
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MVA-nef
Intervention Description
3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
Intervention Type
Biological
Intervention Name(s)
IMVAMUNE
Intervention Description
3 immunizations: 1E8_TCID50 IMVAMUNE
Primary Outcome Measure Information:
Title
T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Occurrence, intensity and relationship of adverse events occurring at any time during the study
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 3 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. Smoking cigarettes now. History of chronic alcohol abuse (40g / day for at least 6 month) and/or intravenous drug abuse (within the past 6 month). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. History of anaphylaxis or severe allergic reaction. Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment. Any vaccinations with active vaccines within a period starting 30 days prior to administration of the vaccine and ending 30 days after administration of the study vaccine. Any vaccinations with inactive vaccines within a period starting 14 days prior to administration of the vaccine and ending 14 days after administration of the study vaccine. Chronic administration (defined as more than 14 days) of immuno- suppressant or immune-modifying drugs during the study period (Corticosteroid nasal sprays are permissible. Subjects who have used topical and inhaled steroids can be enrolled after their therapy is completed). Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is longer) preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Harrer, MD
Organizational Affiliation
University of Erlangen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Doctor's Practice
City
Fuerth
State/Province
Bavaria
ZIP/Postal Code
90762
Country
Germany
Facility Name
Doctor's Practice
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80335
Country
Germany
Facility Name
Doctor's Practice
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80801
Country
Germany
Facility Name
Doctor's Practice
City
Nürnberg
State/Province
Bavaria
ZIP/Postal Code
90641
Country
Germany

12. IPD Sharing Statement

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

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