HIV InfectionPhase 12009-016578-34NCT01571466
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
A Phase 1 study testing Vaccination in people with HIV Infection, run by Hospital Clinic of Barcelona at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08915
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007
About this study
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
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.
- Conditions
- HIV Infection
- Being tested
- Vaccination, Placebo
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationDrug
- 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
PlaceboDrug
3 immunisations at week 0, 4 and 16
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group | Experimental | Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) (MVA HIV-B) Receives: Drug: Vaccination |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary safety parameters
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
Measured: week 8
Primary immunogenicity parameters
Cellular responses - CD8/CD4+ T cell responses (ELISPOT)
Measured: After each inmunisation and at weeks 6-8 and 18-20
Secondary outcomes (4)
All grade 1 and 2 adverse events
Measured: week 8
Viral load rebound
After HAART interruption compared between both arms and with baseline viral load before any medication in each arm
Measured: week 48
Antibody responses
- binding titration to the construct MVAB
- binding titration to and neutralisation of vaccinia
Measured: 48 weeks
Cellular responses
Intracellular cytokine analysis
Measured: Week 6 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Garcia, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571466
- Sponsor's protocol ID
- RisVac 03
- Acronym
- 2009-016578-34
- Status last verified
- Mar 2015
- First submitted
- 9 Nov 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gomez CE, Perdiguero B, Garcia-Arriaza J, Cepeda V, Sanchez-Sorzano CO, Mothe B, Jimenez JL, Munoz-Fernandez MA, Gatell JM, Lopez Bernaldo de Quiros JC, Brander C, Garcia F, Esteban M. A Phase I Randomized Therapeutic MVA-B Vaccination Improves the Magnitude and Quality of the T Cell Immune Responses in HIV-1-Infected Subjects on HAART. PLoS One. 2015 Nov 6;10(11):e0141456. doi: 10.1371/journal.pone.0141456. eCollection 2015.
PubMed 26544853Mothe B, Climent N, Plana M, Rosas M, Jimenez JL, Munoz-Fernandez MA, Puertas MC, Carrillo J, Gonzalez N, Leon A, Pich J, Arnaiz JA, Gatell JM, Clotet B, Blanco J, Alcami J, Martinez-Picado J, Alvarez-Fernandez C, Sanchez-Palomino S, Guardo AC, Pena J, Benito JM, Rallon N, Gomez CE, Perdiguero B, Garcia-Arriaza J, Esteban M, Lopez Bernaldo de Quiros JC, Brander C, Garcia F; RISVAC-03 Study Group. Safety and immunogenicity of a modified vaccinia Ankara-based HIV-1 vaccine (MVA-B) in HIV-1-infected patients alone or in combination with a drug to reactivate latent HIV-1. J Antimicrob Chemother. 2015;70(6):1833-42. doi: 10.1093/jac/dkv046. Epub 2015 Feb 26.
PubMed 25724985
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01571466
- Acronym / sponsor ID
- 2009-016578-34 / RisVac 03
- Conditions
- HIV Infection
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine group | Experimental | Drug: VaccinationModified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) (MVA HIV-B) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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*);
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Vaccine group |
| Placebo3 immunisations at week 0, 4 and 16 | Drug | Placebo |
Primary outcome
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)
4 secondary outcomes
All grade 1 and 2 adverse events
Time frame: week 8
Viral load rebound
Time frame: week 48
Antibody responses
Time frame: 48 weeks
Cellular responses
Time frame: Week 6 and 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 26544853Gomez CE, Perdiguero B, Garcia-Arriaza J, Cepeda V, Sanchez-Sorzano CO, Mothe B, Jimenez JL, Munoz-Fernandez MA, Gatell JM, Lopez Bernaldo de Quiros JC, Brander C, Garcia F, Esteban M. A Phase I Randomized Therapeutic MVA-B Vaccination Improves the Magnitude and Quality of the T Cell Immune Responses in HIV-1-Infected Subjects on HAART. PLoS One. 2015 Nov 6;10(11):e0141456. doi: 10.1371/journal.pone.0141456. eCollection 2015.
- Derived from this study: PubMed 25724985Mothe B, Climent N, Plana M, Rosas M, Jimenez JL, Munoz-Fernandez MA, Puertas MC, Carrillo J, Gonzalez N, Leon A, Pich J, Arnaiz JA, Gatell JM, Clotet B, Blanco J, Alcami J, Martinez-Picado J, Alvarez-Fernandez C, Sanchez-Palomino S, Guardo AC, Pena J, Benito JM, Rallon N, Gomez CE, Perdiguero B, Garcia-Arriaza J, Esteban M, Lopez Bernaldo de Quiros JC, Brander C, Garcia F; RISVAC-03 Study Group. Safety and immunogenicity of a modified vaccinia Ankara-based HIV-1 vaccine (MVA-B) in HIV-1-infected patients alone or in combination with a drug to reactivate latent HIV-1. J Antimicrob Chemother. 2015;70(6):1833-42. doi: 10.1093/jac/dkv046. Epub 2015 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccination in people with HIV Infection, run by Hospital Clinic of Barcelona at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary safety parameters (time frame: week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.