Evaluation of the Safety of a Polyvalent Virus in Healthy Adults

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is a research study to evaluate the safety of a vaccine to protect people from HIV infection. Human Immunodeficiency Virus (HIV) is the cause of AIDS (Acquired Immune Deficiency Syndrome). AIDS is one of the most serious viral infections of our time. It is believed that all persons who contract HIV will eventually develop AIDS. Because of this, we are trying to develop new ways to prevent infection with HIV.

Vaccines have been very successful in preventing or decreasing the symptoms of a number of other viral infections such as hepatitis B, polio, and measles. Viral vaccines work by causing a person's immune system to make antibodies and immune cells against the virus or to "respond" to the virus. Because of the success with other viral infections, scientists are trying to develop a successful vaccine for HIV.

The vaccine that will be tested in this study has been prepared from a small part of the HIV. The part of the HIV used in this vaccine is the "envelope" or coating part of the virus. Because only this one part of the virus is used in the vaccine, the vaccine cannot cause HIV infection. The "envelope" part of HIV has been put into another virus, the vaccinia virus. The vaccinia virus has been used as a vaccine for many decades in millions of people and is the vaccine that eliminated the disease known as smallpox (i.e. smallpox vaccine). The smallpox vaccine is a licensed and effective vaccine. Making a new vaccine by putting part of a different virus into the smallpox vaccine (also known as vaccinia virus) is called a "recombinant" vaccinia virus vaccine. Our new recombinant vaccine product is called PolyEnv1. In this study, researchers will evaluate how well the vaccine is tolerated, how much vaccine should be given, and determine if any side effects occur in response to the vaccination. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00187044
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	October 1997
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02135419` - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions	Phase 3
Active, not recruiting	`NCT02663856` - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed	`NCT02846402` - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda	N/A
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02663869` - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed	`NCT02659306` - Metformin Immunotherapy in HIV Infection	Phase 1
Completed	`NCT02921516` - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings	N/A
Completed	`NCT02564341` - Targeting Effective Analgesia in Clinics for HIV - Intervention	N/A
Active, not recruiting	`NCT02302950` - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas	N/A
Completed	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Completed	`NCT02269605` - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment	Phase 1
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Completed	`NCT01830595` - Lactoferrin Treatment in HIV Patients	Phase 2
Terminated	`NCT02109224` - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection	Phase 1
Completed	`NCT02527135` - Text Messaging to Improve HIV Testing Among Young Women in Kenya	N/A
Completed	`NCT02118168` - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002	N/A
Completed	`NCT01946217` - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials	N/A
Completed	`NCT02525146` - Birmingham Access to Care Study	N/A
Active, not recruiting	`NCT02602418` - Neural Correlates of Working Memory Training for HIV Patients	N/A
Completed	`NCT01702974` - Immune Reconstitution in HIV Disease (IREHIV)	Phase 2