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Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults

NCT00083603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

Empty TBC-FPV

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

TBC-MVA and TBC-FPV

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

BIOLOGICAL

TBC-MVA and TBC-FPV

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

BIOLOGICAL

TBC-MVA and TBC-FPV

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael Keefer, MD · University of Rochester

  • Sharon Frey, MD · St. Louis University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Completion
2007-08-31

Countries

  • United States
  • Brazil

Study Locations

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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 NCT00083603 on ClinicalTrials.gov