HIV InfectionPhase 2NCT00189930
An Evaluation of Immunogenicity and Safety of Two Doses of MVA-nef vs. MVA-BN in HIV-1 Infected Patients
A Phase 2 study testing MVA-nef and IMVAMUNE in people with HIV Infection, run by Bavarian Nordic at 5 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- MVA-nef and IMVAMUNE
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 5 sitesGermany
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
University of Erlangen
Erlangen, Bavaria, 91054
Doctor's Practice
Fürth, Bavaria, 90762
Doctor's Practice
Munich, Bavaria, 80335
Doctor's Practice
Munich, Bavaria, 80801
Doctor's Practice
Nuremberg, Bavaria, 90641
About this study
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
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
- Being tested
- MVA-nef, IMVAMUNE
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-nefBiological
3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
IMVAMUNEBiological
3 immunizations: 1E8_TCID50 IMVAMUNE
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High dose Receives: Biological: MVA-nef |
| 2 | Active comparator | Low dose Receives: Biological: MVA-nef |
| 3 | Placebo comparator | Not described Receives: Biological: IMVAMUNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)
Measured: 52 Weeks
Secondary outcomes (1)
Occurrence, intensity and relationship of adverse events occurring at any time during the study
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Thomas Harrer, MD, Principal investigator, University of Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189930
- Sponsor's protocol ID
- HIV-NEF-004
- Other IDs
- HHSN266200400072C
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2005
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00189930
- Acronym / sponsor ID
- HIV-NEF-004
- Conditions
- HIV Infection
- Keywords
- Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MVA-nefHigh dose |
| 2 | Active comparator | Biological: MVA-nefLow dose |
| 3 | Placebo comparator | Biological: IMVAMUNE |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-nef3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm | Biological | 1, 2 |
| IMVAMUNE3 immunizations: 1E8_TCID50 IMVAMUNE | Biological | 3 |
Primary outcome
T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS)
Time frame: 52 Weeks
1 secondary outcome
Occurrence, intensity and relationship of adverse events occurring at any time during the study
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Harrer, MD principal investigator
University of Erlangen, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-nef and IMVAMUNE in people with HIV Infection, run by Bavarian Nordic at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-cell response against MVA-BN and the Nef antigen assessed by intracellular cytokine staining assay (ICS) (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.