NCT00011037

Brief 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.)

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2001

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

February 8, 2001

Last Update Submit

October 13, 2021

Conditions

HIV InfectionsHIV Seronegativity

Keywords

HIV AntibodiesHIV AntigensHIV Envelope Protein gp120AIDS VaccinesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesNeutralization TestsHaitiBrazilCytotoxicity, ImmunologicEpitopesViral ProteinsTrinidad and TobagoPeruHIV Preventive VaccineHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity and safety of two vaccine regimens

    Throughout study

Study Arms (3)

1

EXPERIMENTAL

Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6

Biological: ALVAC(2)120(B,MN)GNP (vCP1452)Biological: MN rgp120/HIV-1

2

EXPERIMENTAL

Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6

Biological: ALVAC(2)120(B,MN)GNP (vCP1452)Biological: MN rgp120/HIV-1 placebo

3

PLACEBO COMPARATOR

Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6

Biological: ALVAC(2)120(B,MN)GNP (vCP1452) placeboBiological: MN rgp120/HIV-1 placebo

Interventions

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

1 x 10\^ 7 TCID50 administered intramuscularly

12
MN rgp120/HIV-1BIOLOGICAL

0.6 mg administered intramuscularly

1
ALVAC(2)120(B,MN)GNP (vCP1452) placeboBIOLOGICAL

ALVAC placebo administered intramuscularly

3
MN rgp120/HIV-1 placeboBIOLOGICAL

Alum placebo administered intramuscularly

23

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers may be eligible for this study if they:
  • Are from Brazil (Rio de Janeiro), Haiti, Peru, or Trinidad and Tobago.
  • Are 18 to 60 years old.
  • Are HIV-negative.
  • Have not developed a sexually transmitted disease in the last 6 months.
  • Have had no more than 2 sexual partners in the last 6 months.
  • Have not injected drugs or used crack cocaine in the last 6 months.
  • Have not exchanged sex for money or drugs in the last 6 months.
  • Have used an adequate birth control method for 1 month prior to study injections and intend to continue for the injection period (7 months).
  • Are available for 18 months of follow-up.
  • Have a normal history and physical examination.

You may not qualify if:

  • Volunteers will not be eligible for this study if they:
  • Have had immune diseases, chronic illness, or cancer (unless cured by surgical removal), or have used medications affecting the immune system.
  • Have a medical or mental condition, or job that interferes with the study requirements.
  • Have a sexual partner who is HIV-infected, unless practicing abstinence or have always used condoms for the last 6 months.
  • Have a sexual partner at high risk of HIV infection.
  • Have received live vaccines or experimental agents within 30 days prior to planned vaccination.
  • Have received blood products or immunoglobulin in the past 6 months.
  • Have active tuberculosis.
  • Have had a severe allergic reaction, including 1 requiring hospitalization or medical care, or a serious reaction to vaccines.
  • Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
  • Are pregnant or breast-feeding.
  • Are allergic to egg products, thimerosal, or neomycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Projeto Praça Onze/Hesfa Crs

Rio de Janeiro, Brazil

Location

Les Centres GHESKIO CRS

Port-au-Prince, Haiti

Location

Barranco CRS

Lima, Peru

Location

CCPRI Med. Ctr. - Med. Research Foundation of Trinidad & Tobago

Port of Spain, Trinidad and Tobago

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Peter Wright

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2001

First Posted

August 31, 2001

Study Completion

July 1, 2004

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

TR(1)PE(1)BR(1)HA(1)