Clinical trial NCT00316589: Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
treatment experienced
treatment vaccinia naive
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-04-21
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: * Genders eligible for Study: Both
* Age: between 18 and 55 years
* Healthy volunteers are accepted

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: within 32 weeks
Secondary outcomes:
measure: Related Grade >=3 Adverse Events
timeFrame: within 29 days after any vaccination
measure: Solicited Local Adverse Events
timeFrame: within 8 days after any vaccination
measure: Solicited General Adverse Events
timeFrame: within 8 days after any vaccination
measure: Unsolicited Adverse Events: Incidence
timeFrame: within 29 days after any vaccination
measure: Unsolicited Adverse Events: Intensity
timeFrame: within 29 days after any vaccination
measure: Unsolicited Adverse Events: Relationship to Vaccination
timeFrame: within 29 days after any vaccination
measure: CD4+ T-cell Counts
timeFrame: within 32 weeks
measure: CD8+ T-cell Counts
timeFrame: within 32 weeks
measure: Viral Load
timeFrame: within 32 weeks
measure: PRNT Seroconversion Rate
timeFrame: within 32 weeks
measure: PRNT GMT
timeFrame: within 32 weeks
measure: ELISA Seroconversion Rate
timeFrame: within 32 weeks
measure: ELISA GMT
timeFrame: within 32 weeks
measure: ELISPOT IFN-γ: Response Rate
timeFrame: within 32 weeks
measure: ELISPOT IFN-γ: SFU
timeFrame: within 32 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine Research Clinic; University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Health for Life Clinic, PLLC
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Carmichael
country: United States
facility: Northern California Research
state: California
city: Fountain Valley
country: United States
facility: CSI Clinical Trials, Inc.
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center, East Bay AIDS Center
state: California
city: San Francisco
country: United States
facility: Benchmark Clinical Research
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Daytona Beach
country: United States
facility: Consultive Medicine
state: Florida
city: Fort Lauderdale
country: United States
facility: Northpoint Medical, PA
state: Florida
city: Miami
country: United States
facility: The Kinder Medical Group
state: Florida
city: Pensacola
country: United States
facility: Infectious Diseases of NW Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta ID Group
state: Georgia
city: Chicago
country: United States
facility: The CORE Center
state: Illinois
city: Chicago
country: United States
facility: Northstar Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine; Division of Infectious Disease
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa, Division of Infectious Diseases
state: Iowa
city: Kansas City
country: United States
facility: Nemechek Health Renewal
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University, Center for Vaccine Dev.
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: Immuniodeficiency Clinic, ECMC
state: New York
city: Rochester
country: United States
facility: Universtity of Rochester School of Medicine
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services
state: Pennsylvania
city: Providence
country: United States
facility: Brown Medical School
state: Rhode Island
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University, AIDS Clinical Trials Center
state: Tennessee
city: Dallas
country: United States
facility: Nicholaos C. Bellos, MD PA
state: Texas
city: Harlingen
country: United States
facility: Valley AIDS Council
state: Texas
city: Houston
country: United States
facility: Diversified Medical Practices
state: Texas
city: San Juan
country: Puerto Rico
facility: Clinical Research P.R., Inc.
city: San Juan
country: Puerto Rico
facility: Maternal Infant Studies Center (CEMI)
Study officials:
affiliation: Washington University School of Medicine
name: Edgar Turner Overton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.