Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1
      proteome into one chimaeric protein. This gene has been inserted into 2 leading
      non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63)
      and a modified vaccinia virus Ankara (MVA) to construct the ChAdV63.HIVconsv and MVA.HIVconsv
      HIV-1 candidate vaccines. The present study is named ChAd-MVA.HIVconsv-BCN01 and it is a
      phase I, multicenter primary/booster therapeutic vaccination study to evaluate the safety and
      immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly
      according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with
      early viral suppression 6 months after initiation of Tenofovir/Emtricitabine plus
      Raltegravir.
    

Detailed description: 
      It is a Phase I, multicenter primary/booster therapeutic vaccination study to evaluate the
      safety and immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered
      intramuscularly according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected
      individuals with early viral suppression 6 months after initiation of Tenofovir/Emtricitabine
      plus Raltegravir.

      24 patients who meet all eligibility criteria will be enrolled, first 10 individuals will be
      assigned in the 0-24 week prime/boost regimen (ARM A). The next 10 volunteers will be
      assigned in the 0-8 week prime/boost regimen (ARM B).Four additional volunteers will be
      included as 'back-up' and assigned 2 in ARM A and 2 in ARM B to cover a possible 10% of
      patients who drop-off during the follow-up. Purpose of staging of 2 study arms is just to
      shorten overall study duration (from screening of first volunteer to 6 months after last
      immunisation of last volunteer).

      Lastly, 24 patients who also meet all eligibility criteria will be enrolled as controls, will
      also initiate promptly antiretroviral treatment with Tenofovir/Emtricitabine plus Raltegravir
      but will not receive the investigational vaccines. Control patients will consecutively be
      assigned to the 0-24w control arm (ARM C 'long control') or 0-8w control arm (ARM D 'short
      control') until 12 patients per arm are reached. The purpose of the control arms is to have a
      study population to compare the viral reservoir decay kinetics in the absence of vaccination.
    

Intervention name(s): 0-24 week prime/boost regimen; 0-8 week prime/boost regimen
Intervention type(s): Biological; Biological
Intervention description(s): ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly; ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly
Other intervention name(s): ARM A; ARM B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaccine; recently HIV-1 infected individuals