ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

NCT00011037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-10-14

No results posted yet for this study

Summary

The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120.

HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)

Conditions

  • HIV Infections
  • HIV Seronegativity

Interventions

BIOLOGICAL

ALVAC(2)120(B,MN)GNP (vCP1452)

1 x 10\^ 7 TCID50 administered intramuscularly

BIOLOGICAL

MN rgp120/HIV-1

0.6 mg administered intramuscularly

BIOLOGICAL

ALVAC(2)120(B,MN)GNP (vCP1452) placebo

ALVAC placebo administered intramuscularly

BIOLOGICAL

MN rgp120/HIV-1 placebo

Alum placebo administered intramuscularly

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Peter Wright

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Completion
2004-07-31

Countries

  • Brazil
  • Haiti
  • Peru
  • Trinidad and Tobago

Study Locations

More Related Trials

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 NCT00011037 on ClinicalTrials.gov