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)
![]() |
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: NCT01571466 |
Recruitment Status :
Completed
First Posted : April 5, 2012
Last Update Posted : April 1, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Vaccination Drug: Placebo | Phase 1 |
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 |
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
|
Placebo Comparator: Placebo |
Drug: Placebo
3 immunisations at week 0, 4 and 16 |
- 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)
- 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

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
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 |
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 |