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A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART (2009-016578-34)

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ClinicalTrials.gov Identifier: NCT01571466
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Vaccination Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind Phase I Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
Study Start Date : September 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccine group
Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) (MVA HIV-B)
 Drug: Vaccination

  • Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)

    -~ 1 x 10e8 pfu/ml

  • 3 immunisations at week 0, 4 and 16
Placebo Comparator: Placebo Drug: Placebo
3 immunisations at week 0, 4 and 16


Outcome Measures
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Primary Outcome Measures :
  1. primary safety parameters [ Time Frame: week 8 ]
    Grade 3 or above local adverse event (pain, cutaneous reactions including induration) Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia) Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively Any event attributable to vaccine leading to discontinuation of the immunisation regimen

  2. Primary immunogenicity parameters [ Time Frame: After each inmunisation and at weeks 6-8 and 18-20 ]
    Cellular responses - CD8/CD4+ T cell responses (ELISPOT)


Secondary Outcome Measures :
  1. All grade 1 and 2 adverse events [ Time Frame: week 8 ]
  2. Viral load rebound [ Time Frame: week 48 ]
    After HAART interruption compared between both arms and with baseline viral load before any medication in each arm

  3. Antibody responses [ Time Frame: 48 weeks ]
    • binding titration to the construct MVAB
    • binding titration to and neutralisation of vaccinia

  4. Cellular responses [ Time Frame: Week 6 and 18 ]
    Intracellular cytokine analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years of age;
  • Voluntarily signed informed consent;
  • Patient is male, or female with negative pregnancy test prior to enrolment;
  • Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA);
  • Patient must be on stable treatment with HAART for at least 6 months (HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents*);
  • Mean of all measured CD4+ cell counts during the 6 months prior to the start of HAART must be above or equal to 200 cells/ mm3
  • Current CD4+ cell count must be at least 450 cells/ mm3;
  • HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted);
  • Patient is one of the following: not sexually active, or a heterosexually active female, agreeing to use condoms with her partner from 14 days prior to the first vaccination until 4 months after the last, even though using another method of contraception, and willing to undergo pregnancy tests during screening and prior to each vaccination, or a male, agreeing to use condoms with his partner from the day of the first vaccination until 4 months after the last vaccination.

Exclusion Criteria:

  • Treatment with a non-HAART regimen of antiretroviral agents prior to the start of HAART;
  • History of a CDC class C event (see Appendix);
  • Interruption of HAART during the course of the study which is expected at the time of inclusion;
  • History of exposure <20 years ago to any poxvirus based vaccine;
  • Patient is female and has a positive pregnancy test or the wish of pregnancy:
  • Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
  • Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
  • History of allergy to any vaccine component;
  • Use of anti-coagulant medication;
  • Use of any investigational drug during the 90 days prior to study entry;
  • Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy
  • Any other condition which, in the opinion
Contacts and Locations
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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): NCT01571466


Locations
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08915
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Felipe Garcia, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01571466     History of Changes
Other Study ID Numbers: RisVac 03
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs