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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01571466
First received: November 9, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
HIV Infection
Drug: Vaccination
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • primary safety parameters [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    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

  • Primary immunogenicity parameters [ Time Frame: After each inmunisation and at weeks 6-8 and 18-20 ] [ Designated as safety issue: No ]
    Cellular responses - CD8/CD4+ T cell responses (ELISPOT)


Secondary Outcome Measures:
  • All grade 1 and 2 adverse events [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
  • Viral load rebound [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    After HAART interruption compared between both arms and with baseline viral load before any medication in each arm

  • Antibody responses [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    • binding titration to the construct MVAB
    • binding titration to and neutralisation of vaccinia

  • Cellular responses [ Time Frame: Week 6 and 18 ] [ Designated as safety issue: Yes ]
    Intracellular cytokine analysis


Enrollment: 30
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Felipe Garcia, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01571466     History of Changes
Other Study ID Numbers: RisVac 03
Study First Received: November 9, 2011
Last Updated: February 25, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014