CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 150 enrolled
Drug / intervention
rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT) +7 morebiological
Likely dose
rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT) 2mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00083603
NCT00083603Phase 1Completed
CompareCT.gov

A Phase I Trial to Evaluate the Safety and Immunogenicity of rMVA-HIV (rMVA-HIV Env/Gag + rMVA-HIV Tat/Rev/Nef-RT) and rFPV-HIV (rFPV-HIV Env/Gag + rFPV-HIV Tat/Rev/Nef-RT) Vaccines, Alone or in Combination, in Healthy, Vaccinia Naive HIV-1 Negative Participants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 27, 2004·Updated Oct 14, 2021

In Brief

A Phase 1 clinical trial evaluating rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT), rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT), and 2 other interventions for HIV Infections. Completed, enrolled 150 participants across 6 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, United States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 27, 2004
Enrollment StartSep 1, 2004
Study CompletionAug 1, 2007
TodayJul 2, 2026
Posted 22.1 years ago

Interventions

rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)biological

rMVA 10\^7 pfu /2mL administered in each deltoid

rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)biological

Vaccines administered as two separate 1-mL intramuscular injections, with rFPV-HIV env/gag into the left deltoid, rFPV-HIV tat/rev/nef-RT into the right deltoid

Empty TBC-FPVbiological

Empty FPV 10\^9 pfu/2mL administered as two separate 1 mL intramuscular injections, one into each deltoid.

rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)biological

rMVA 10\^8 pfu /2mL administered in each deltoid

rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)biological

rMVA 10\^9 pfu /2mL administered in each deltoid

TBC-MVA and TBC-FPVbiological

Empty MVA 10\^7 pfu/2mL administered into each deltoid

TBC-MVA and TBC-FPVbiological

Empty MVA 10\^8 pfu/2mL administered into each deltoid

TBC-MVA and TBC-FPVbiological

Empty MVA 10\^9 pfu/2mL administered into each deltoid