NCT01571466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

November 9, 2011

Last Update Submit

March 31, 2015

Conditions

HIV Infection

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (2)

  • 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

    week 8

  • Primary immunogenicity parameters

    Cellular responses - CD8/CD4+ T cell responses (ELISPOT)

    After each inmunisation and at weeks 6-8 and 18-20

Secondary Outcomes (4)

  • All grade 1 and 2 adverse events

    week 8

  • Viral load rebound

    week 48

  • Antibody responses

    48 weeks

  • Cellular responses

    Week 6 and 18

Study Arms (2)

Vaccine group

EXPERIMENTAL

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

Drug: Vaccination

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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

Vaccine group
PlaceboDRUG

3 immunisations at week 0, 4 and 16

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • Treatment with a non-HAART regimen of antiretroviral agents prior to the start of HAART;
  • History of a CDC class C event (see Appendix);
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08915, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Related Publications (2)

  • 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.

    PMID: 26544853DERIVED

  • Mothe 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.

    PMID: 25724985DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2011

First Posted

April 5, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

ES(3)