AzTrials
AzTrials

HIV InfectionsPhase 2NCT00316589

Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

A Phase 2 study testing IMVAMUNE (MVA-BN) in people with HIV Infections, run by Bavarian Nordic at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
IMVAMUNE (MVA-BN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
581 participants
Where
36 sitesin 2 countries
Study dates
Jun 2006to Oct 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects tested positive for HIV-1 infection (HIV-infected subjects).
  • Subjects that are tested negative for HIV (Healthy subjects).
  • Either on stable antiretroviral therapy or not on antiretroviral therapy.
  • CD4 cells > = 200 - 750/µl.
  • Subjects must be in good general health except for HIV infection.
  • Women must not be pregnant and use an acceptable method of contraception.

Who cannot join

  • Impairment of immunologic function (other than HIV infection).
  • History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
  • Uncontrolled serious infection.
  • History of or active autoimmune disease.
  • History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
Show all 12Show fewer
  • High risk of developing a myocardial infarction or coronary death.
  • History of intravenous drug abuse (within the last 12 months).
  • Known allergy to egg or aminoglycoside (gentamicin).
  • History of anaphylaxis or severe allergic reaction.
  • Subjects undergoing treatment for tuberculosis infection or disease.
  • Chronic administration of systemic immuno-suppressants.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States34 sites

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • Alabama Vaccine Research Clinic; University of Alabama at Birmingham

    Birmingham, Alabama, 35294-2050

  • Immuniodeficiency Clinic, ECMC

    Buffalo, New York, 14260

  • Providence Clinical Research

    Burbank, California, 91505

  • Northern California Research

    Carmichael, California, 95608

  • The CORE Center

    Chicago, Illinois, 60612

  • Northstar Medical Center

    Chicago, Illinois, 60657

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • University of South Carolina

    Columbia, South Carolina, 29203

  • Nicholaos C. Bellos, MD PA

    Dallas, Texas, 75204

  • Consultive Medicine

    Daytona Beach, Florida, 32117

  • Northpoint Medical, PA

    Fort Lauderdale, Florida, 33308

  • CSI Clinical Trials, Inc.

    Fountain Valley, California, 92708

  • Valley AIDS Council

    Harlingen, Texas, 78550

  • Diversified Medical Practices

    Houston, Texas, 77027

  • Indiana University School of Medicine; Division of Infectious Disease

    Indianapolis, Indiana, 46202-2859

  • University of Iowa, Division of Infectious Diseases

    Iowa City, Iowa, 52242

  • Nemechek Health Renewal

    Kansas City, Missouri, 64111

  • Health for Life Clinic, PLLC

    Little Rock, Arkansas, 72207

  • AltaMed Health Services

    Los Angeles, California, 90022

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Vanderbilt University, AIDS Clinical Trials Center

    Nashville, Tennessee, 37203

  • Alta Bates Summit Medical Center, East Bay AIDS Center

    Oakland, California, 94609

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5130

  • Infectious Diseases of NW Florida

    Pensacola, Florida, 32504

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-6073

  • Clinical Trials Research Services

    Pittsburgh, Pennsylvania, 15206

  • Brown Medical School

    Providence, Rhode Island, 02906

  • Universtity of Rochester School of Medicine

    Rochester, New York, 14642

  • Benchmark Clinical Research

    San Francisco, California, 94102

  • St. Louis University, Center for Vaccine Dev.

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Palm Beach Center

    West Palm Beach, Florida, 33409

Other trials in United States

Puerto Rico2 sites

  • Clinical Research P.R., Inc.

    San Juan, 00909

  • Maternal Infant Studies Center (CEMI)

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations

Conditions
HIV Infections
Being tested
IMVAMUNE (MVA-BN)
Keywords
HIV, treatment experienced, treatment vaccinia naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMVAMUNE (MVA-BN)Biological

    Also called IMVANEX

    2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous

Study groups in NCT00316589
Study groupRoleWhat they receive
Healthy subjectsExperimentalControl group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
Receives: Biological: IMVAMUNE (MVA-BN)
HIV-infected, vaccinia-naiveExperimentalSubjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Receives: Biological: IMVAMUNE (MVA-BN)
HIV-infected, vaccinia-experiencedExperimentalSubjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Receives: Biological: IMVAMUNE (MVA-BN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events

    Incidence, relationship and intensity of any Serious Adverse Event (SAE)

    Measured: within 32 weeks

Secondary outcomes (15)

  1. Related Grade >=3 Adverse Events

    Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine

    Measured: within 29 days after any vaccination

  2. Solicited Local Adverse Events

    Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.

    Measured: within 8 days after any vaccination

  3. Solicited General Adverse Events

    Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.

    Measured: within 8 days after any vaccination

  4. Unsolicited Adverse Events: Incidence

    Incidence of any unsolicited adverse events

    Measured: within 29 days after any vaccination

  5. Unsolicited Adverse Events: Intensity

    Occurrence of unsolicited adverse events by Intensity

    Measured: within 29 days after any vaccination

  6. Unsolicited Adverse Events: Relationship to Vaccination

    Occurrence of unsolicited adverse events by relationship to study vaccine

    Measured: within 29 days after any vaccination

  7. CD4+ T-cell Counts

    Median CD4+ T-cell counts over time

    Measured: within 32 weeks

  8. CD8+ T-cell Counts

    Median CD8+ T-cell counts over time

    Measured: within 32 weeks

  9. Viral Load

    Viral load (HIV-1 RNA levels) over time

    Measured: within 32 weeks

  10. PRNT Seroconversion Rate

    Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

    Measured: within 32 weeks

  11. PRNT GMT

    Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.

    Measured: within 32 weeks

  12. ELISA Seroconversion Rate

    Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

    Measured: within 32 weeks

  13. ELISA GMT

    Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.

    Measured: within 32 weeks

  14. ELISPOT IFN-γ: Response Rate

    Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.

    Measured: within 32 weeks

  15. ELISPOT IFN-γ: SFU

    Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.

    Measured: within 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMar 2009
  4. Study completionOct 2009

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
581 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316589
Sponsor's protocol ID
POX-MVA-011
Status last verified
Dec 2018
First submitted
19 Apr 2006
Last updated
3 Jan 2019
Data monitoring committee
Yes

Publications

  • Overton ET, Stapleton J, Frank I, Hassler S, Goepfert PA, Barker D, Wagner E, von Krempelhuber A, Virgin G, Meyer TP, Muller J, Badeker N, Grunert R, Young P, Rosch S, Maclennan J, Arndtz-Wiedemann N, Chaplin P. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial. Open Forum Infect Dis. 2015 May 5;2(2):ofv040. doi: 10.1093/ofid/ofv040. eCollection 2015 Apr.

    PubMed 26380340

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMVAMUNE (MVA-BN) in people with HIV Infections, run by Bavarian Nordic at 36 sites in 2 countries.

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 6 inclusion and 12 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Puerto Rico. 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. 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?

Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serious Adverse Events (time frame: within 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00316589, which also lists 1 linked publication.

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 3 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in