Clinical trialNCT02038881CompletedPhase 2Interventional

Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection

SponsorBavarian NordicEnrollment87Smallpox

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Edgar T Overton, MD
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Clinical Research Puerto Rico, Inc.
San Juan, PR, Puerto Rico
Fundacion de Investigacion
San Juan, PR, Puerto Rico

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
Health for Life Clinic Little Rock
Little Rock, Arkansas, United States
Quest Clinical Research
San Francisco, California, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Infectious Disease Associats of Nw Florida Center for Prevention and Treatment of Infections Infectious Diseases Associates of Nw Fl
Pensacola, Florida, United States
Rowan Tree Medical
Wilton Manors, Florida, United States
University of Illinois - Chicago
Chicago, Illinois, United States
University of Iowa Departments of Internal Medicine and Microbiology University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Pennsylvania Clinical Trials Unit
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IMVAMUNE®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Apr 2014
Primary completion: 10 May 2017
Completion: 10 May 2017
Last update posted: 2 Apr 2020
Registered enrollment: 87
Registry id: NCT02038881

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.