Search / Trial NCT00000774

A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

Vaccines, Synthetic Virus Replication Hiv Envelope Protein Gp120 Aids Vaccines Hiv Preventive Vaccine Hiv Therapeutic Vaccine

Description

Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression. Newborns are randomized to one of three different doses of either rgp120/HIV-1MN or rgp120/HIV-1SF2 or their matching placebos. At each dose level, 12 patients receive vaccine and three patients receive placebo. Immunizations are performed at 0, 4, 12, and 20 weeks, and patients are followed until 2 years of age. Three of four...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization.
  • Routine immunizations if given more than 1 week before or after study vaccine.
  • Patients must be:
  • > 37 weeks gestation and < 72 hours of age born to HIV-infected women.
  • NOT born to women who received either passive or active immunotherapy during pregnancy.
  • NOT breast-fed.
  • NOT born to women who are hepatitis B surface antigen positive.
  • Receiving AZT at study entry (except infants enrolled in ACTG 076).
  • NOTE:
  • Parent or guardian must provide informed consent and be willing to comply with study requirements.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions.
  • Concurrent Medication:
  • Excluded:
  • Passive or active HIV-specific immunotherapy other than the study candidate vaccines.
  • Investigational medications.

Attachments

readout_NCT00000774_2024-06-13.pdf

4.5 MB

NCT00000774_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Los Angeles, California, United States

San Francisco, California, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Worcester, Massachusetts, United States

Bronx, New York, United States

New York, New York, United States

Durham, North Carolina, United States

Houston, Texas, United States

San Juan, , Puerto Rico

Long Beach, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Paterson, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

San Francisco, California, United States

New Haven, Connecticut, United States

New Orleans, Louisiana, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Throughout study

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0