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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00316589
Recruitment Status : Completed
First Posted : April 21, 2006
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bavarian Nordic

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

Condition or disease Intervention/treatment Phase
HIV Infections Biological: IMVAMUNE (MVA-BN) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 581 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects
Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Other Name: IMVANEX

Experimental: HIV-infected, vaccinia-naive
Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Other Name: IMVANEX

Experimental: HIV-infected, vaccinia-experienced
Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Other Name: IMVANEX




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: within 32 weeks ]
    Incidence, relationship and intensity of any Serious Adverse Event (SAE)


Secondary Outcome Measures :
  1. Related Grade >=3 Adverse Events [ Time Frame: within 29 days after any vaccination ]
    Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine

  2. Solicited Local Adverse Events [ Time Frame: within 8 days after any vaccination ]
    Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.

  3. Solicited General Adverse Events [ Time Frame: within 8 days after any vaccination ]
    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.

  4. Unsolicited Adverse Events: Incidence [ Time Frame: within 29 days after any vaccination ]
    Incidence of any unsolicited adverse events

  5. Unsolicited Adverse Events: Intensity [ Time Frame: within 29 days after any vaccination ]
    Occurrence of unsolicited adverse events by Intensity

  6. Unsolicited Adverse Events: Relationship to Vaccination [ Time Frame: within 29 days after any vaccination ]
    Occurrence of unsolicited adverse events by relationship to study vaccine

  7. CD4+ T-cell Counts [ Time Frame: within 32 weeks ]
    Median CD4+ T-cell counts over time

  8. CD8+ T-cell Counts [ Time Frame: within 32 weeks ]
    Median CD8+ T-cell counts over time

  9. Viral Load [ Time Frame: within 32 weeks ]
    Viral load (HIV-1 RNA levels) over time

  10. PRNT Seroconversion Rate [ Time Frame: within 32 weeks ]
    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.

  11. PRNT GMT [ Time Frame: within 32 weeks ]
    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'.

  12. ELISA Seroconversion Rate [ Time Frame: within 32 weeks ]
    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.

  13. ELISA GMT [ Time Frame: within 32 weeks ]
    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'.

  14. ELISPOT IFN-γ: Response Rate [ Time Frame: within 32 weeks ]
    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.

  15. ELISPOT IFN-γ: SFU [ Time Frame: within 32 weeks ]
    Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316589


Locations
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Sponsors and Collaborators
Bavarian Nordic
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Edgar Turner Overton, MD Washington University School of Medicine
Publications of Results:
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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316589    
Other Study ID Numbers: POX-MVA-011
First Posted: April 21, 2006    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Keywords provided by Bavarian Nordic:
HIV
treatment experienced
treatment vaccinia naive
Additional relevant MeSH terms:
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Smallpox
Infections
Virus Diseases
Poxviridae Infections
DNA Virus Infections