Clinical Trials


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
Hospital Clinic of Barcelona

Information provided by (Responsible Party)
Felipe Garcia, Hospital Clinic of Barcelona Identifier

First received: November 9, 2011
Last updated: March 31, 2015
Last Verified: March 2015
History of Changes


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
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

Further study details as provided by Felipe Garcia, Hospital Clinic of Barcelona:

Primary Outcome Measures

  • 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
  • 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:
  • All grade 1 and 2 adverse events [ Time Frame: week 8 ]
  • 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
  • Antibody responses [ Time Frame: 48 weeks ]
    binding titration to the construct MVAB binding titration to and neutralisation of vaccinia
  • Cellular responses [ Time Frame: Week 6 and 18 ]
    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



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

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 identifier: NCT01571466


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

More Information

Responsible Party: Felipe Garcia, Principal Investigator, Hospital Clinic of Barcelona Identifier: NCT01571466   History of Changes  
Other Study ID Numbers: RisVac 03  
Study First Received: November 9, 2011  
Last Updated: March 31, 2015  

Keywords provided by Felipe Garcia, Hospital Clinic of Barcelona:

HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Vaccines processed this data on May 24, 2020
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