Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals With Early Viral Suppression After Initiation of Antiretroviral Therapy (HAART)

NCT01712425 Phase 1 COMPLETED

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.

Details

Lead sponsor	IrsiCaixa
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2012-10
Completion	2015-10

Conditions

• HIV

Interventions

• 0-24 week prime/boost regimen
• 0-8 week prime/boost regimen

Primary outcomes

• Grade 3 or 4 local reaction — Up to 24 weeks
  The proportion of volunteers who develop a grade 3 or 4 local reaction
• Grade 3 or 4 systemic reaction — Up to 24 weeks
  The proportion of volunteers who develop a grade 3 or 4 systemic reaction
• Serious adverse event, including laboratory abnormalities. — Up to 24 weeks
  The proportion of volunteers who develop a serious adverse event, including laboratory abnormalities.

Countries

Spain