A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART

HIV Infection Clinical Trial

— 2009-016578-34  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571466
• Other study ID #: RisVac 03
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2011
• Last updated: March 31, 2015
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: March 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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. At week 24 they will stop their HAART until the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection

Intervention

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
3 immunisations at week 0, 4 and 16

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Primary immunogenicity parameters	Cellular responses - CD8/CD4+ T cell responses (ELISPOT)	After each inmunisation and at weeks 6-8 and 18-20	No
Secondary	All grade 1 and 2 adverse events		week 8	Yes
Secondary	Viral load rebound	After HAART interruption compared between both arms and with baseline viral load before any medication in each arm	week 48	No
Secondary	Antibody responses	binding titration to the construct MVAB; binding titration to and neutralisation of vaccinia	48 weeks	No
Secondary	Cellular responses	Intracellular cytokine analysis	Week 6 and 18	Yes