CompletedPhase 1

Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals

Spain48 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, aged 18-60 years
✓. Confirmed HIV-1 seropositive documented in the past 6 months (by acute antiretroviral syndrome, p24 antigenemia and/or ELISA seroconversion)
✓. Willing and able to give written informed consent for participation in the study
✓. Willing and able to adhere to an effective HAART regimen for the duration of the study
✓. Cluster of differentiation 4 (CD4)+ T cell count \> 350 cells/ml at screening and at the preceding clinic visit
✓. No new AIDS-defining diagnosis or progression of HIV-related disease.
✓. Haematological and biochemical laboratory parameters as follows: Haemoglobin \> 10g/dl, Platelets \> 100.000/dl, alanine aminotransferase (ALT) ≤ 2.5 x ULN, Creatinine ≤ 1.3 x upper limit of normal (ULN)
✓. Serology: negative for hepatitis B surface antigen OR HbsAg positive with Hepatitis B Virus (HBV)-DNA \< 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of Hepatitis C Virus (HCV) infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive enzimeimmunoassay (EIA) Immonoglobulin G (IgG) or Treponema pallidum hemagglutination assay (TPHA)

What they're measuring

Grade 3 or 4 local reaction

Timeframe: Up to 24 weeks

Grade 3 or 4 systemic reaction

Timeframe: Up to 24 weeks

Serious adverse event, including laboratory abnormalities.

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT01712425

SponsorIrsiCaixa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, aged 18-60 years
✓. Confirmed HIV-1 seropositive documented in the past 6 months (by acute antiretroviral syndrome, p24 antigenemia and/or ELISA seroconversion)
✓. Willing and able to give written informed consent for participation in the study
✓. Willing and able to adhere to an effective HAART regimen for the duration of the study
✓. Cluster of differentiation 4 (CD4)+ T cell count \> 350 cells/ml at screening and at the preceding clinic visit
✓. No new AIDS-defining diagnosis or progression of HIV-related disease.
✓. Haematological and biochemical laboratory parameters as follows: Haemoglobin \> 10g/dl, Platelets \> 100.000/dl, alanine aminotransferase (ALT) ≤ 2.5 x ULN, Creatinine ≤ 1.3 x upper limit of normal (ULN)
✓. Serology: negative for hepatitis B surface antigen OR HbsAg positive with Hepatitis B Virus (HBV)-DNA \< 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of Hepatitis C Virus (HCV) infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive enzimeimmunoassay (EIA) Immonoglobulin G (IgG) or Treponema pallidum hemagglutination assay (TPHA)

Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria