MedTrace Logo

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

NCT01712425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

0-24 week prime/boost regimen

ChAdV63.HIVcons (5x10\^10 vp) and MVA.HIVconsv (2x10\^8 pfu) HIV-1 vaccines, delivered intramuscularly

BIOLOGICAL

0-8 week prime/boost regimen

ChAdV63.HIVcons (5x10\^10 vp) and MVA.HIVconsv (2x10\^8 pfu) HIV-1 vaccines, delivered intramuscularly

Sponsors & Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • HIVACAT

    collaborator UNKNOWN

  • University of Oxford

    collaborator OTHER

  • IrsiCaixa

    lead OTHER

Principal Investigators

  • Christian Brander, PhD · Institut de Recerca de la Sida IrsiCaixa-HIVACAT

  • Beatriz Mothe, MD,PhD · Institut de Recerca de la Sida IrsiCaixa-HIVACAT

  • Josep Maria Miró, MD,PhD · Hospital Clínic i Provincial de Barcelona, HIVACAT

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712425 on ClinicalTrials.gov