NCT01571466: 2009-016578-34

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

Completed Phase 1 Last updated 31 March 2015

What this trial tests

Phase 1 trial testing Vaccination in HIV Infection in 30 participants. Completed in 1 May 2013.

Timeline

1 September 2011

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	30
Start date	1 September 2011
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	3 locations across Spain

Drugs / interventions tested

• Vaccination (vaccination) — full drug profile →
• Placebo

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 re
• Primary immunogenicity parameters
  Time frame: After each inmunisation and at weeks 6-8 and 18-20
  Cellular responses - CD8/CD4+ T cell responses (ELISPOT)

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Mothe B, Climent N, Plana M, Rosàs M, et al · · 2015 · cited 51× · PMID 25724985 · DOI 10.1093/jac/dkv046
2. 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.
   Gómez CE, Perdiguero B, García-Arriaza J, Cepeda V, et al · · 2015 · cited 19× · PMID 26544853 · DOI 10.1371/journal.pone.0141456
3. Impacts of HIV Cure Interventions on Viral Reservoirs in Tissues.
   Denton PW, Søgaard OS, Tolstrup M. · · 2019 · cited 16× · PMID 31497010 · DOI 10.3389/fmicb.2019.01956
4. Virological and immunological outcome of treatment interruption in HIV-1-infected subjects vaccinated with MVA-B.
   Rosás-Umbert M, Mothe B, Noguera-Julian M, Bellido R, et al · · 2017 · cited 16× · PMID 28953921 · DOI 10.1371/journal.pone.0184929
5. Monocytes Phenotype and Cytokine Production in Human Immunodeficiency Virus-1 Infected Patients Receiving a Modified Vaccinia Ankara-Based HIV-1 Vaccine: Relationship to CD300 Molecules Expression.
   Vitallé J, Zenarruzabeitia O, Terrén I, Plana M, et al · · 2017 · cited 7× · PMID 28785262 · DOI 10.3389/fimmu.2017.00836
6. Can we just kick-and-kill HIV: possible challenges posed by the epigenetically controlled interplay between HIV and host immunity.
   Ruiz-Riol M, Brander C. · · 2019 · cited 6× · PMID 31218904 · DOI 10.2217/imt-2019-0092
7. Comparison of Safety and Vector-Specific Immune Responses in Healthy and HIV-Infected Populations Vaccinated with MVA-B.
   Couto E, Diaz-Brito V, Mothe B, Guardo AC, et al · · 2019 · cited 1× · PMID 31703287 · DOI 10.3390/vaccines7040178