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Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
NCT02038881 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's response (protection against smallpox as measured by the amount of antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All participants in this trial will be randomly and evenly assigned to one of three groups to receive two, three or four injections. Group 1 will receive the standard regime consisting of one dose at each vaccination time point, Group 2 will receive two doses at each vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial is scheduled to last up to 75 weeks.
Conditions Studied
Interventions
- BIOLOGICAL IMVAMUNE®
Study Locations (12)
Florida
- Infectious Disease Associats of NW Florida Center for Prevention and Treatment of Infections Infectious Diseases Associates of NW FL — Pensacola
- Rowan Tree Medical — Wilton Manors
PR
- Clinical Research Puerto Rico, Inc. — San Juan
- Fundacion de Investigacion — San Juan
Alabama
- University of Alabama at Birmingham — Birmingham
Arkansas
- Health for Life Clinic Little Rock — Little Rock
California
- Quest Clinical Research — San Francisco
District of Columbia
- Dupont Circle Physicians Group — Washington D.C.
Illinois
- University of Illinois - Chicago — Chicago
Iowa
- University of Iowa Departments of Internal Medicine and Microbiology University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2014-04-28 |
| Est. Completion | 2017-05-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02038881
The ClinicalTrials.gov registry entry for NCT02038881 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 1 intervention — of which IMVAMUNE® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02038881 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Florida, PR, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02038881 about?
NCT02038881 is a clinical study titled "Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection". The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's respons...
What is the current status of trial NCT02038881?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2014-04-28. Estimated completion is 2017-05-10.
What conditions does trial NCT02038881 study?
This clinical trial studies the following conditions: Smallpox. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02038881?
The interventions under investigation include: IMVAMUNE® (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02038881?
This trial is sponsored by Bavarian Nordic, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02038881 being conducted?
This trial has 12 study locations across Alabama, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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