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Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

NCT01024842 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-06-08

No results posted yet for this study

Summary

In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.

MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.

Conditions

Interventions

BIOLOGICAL

MVA.HIVconsv low dose

Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10\^8 pfu at week 0, 4 and 12.

OTHER

Placebo low dose

Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.

BIOLOGICAL

MVA.HIVconsv high dose

Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10\^8 pfu at week 0, 4 and 12.

OTHER

Placebo high dose

Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.

Sponsors & Collaborators

Principal Investigators

  • Tomas Hanke · University of Oxford

  • Andrew McMichael · University of Oxford

  • Lucy Dorrell · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT01024842 on ClinicalTrials.gov