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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000774
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Genentech, Inc.
Biocine
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants.

SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women.

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.


Condition Intervention Phase
HIV Infections HIV Seronegativity Biological: rgp120/HIV-1MN Biological: rgp120/HIV-1 SF-2 Biological: Placebo version of rgp120/HIV-1MN Biological: Placebo version of rgp120/HIV-1SF2 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines [ Time Frame: Throughout study ]
  • Changes in viral load in infants found to be HIV infected [ Time Frame: Throughout study ]
  • Changes in the slope of absolute CD4 counts in all immunized children [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Changes in immune response to the vaccine candidates [ Time Frame: Throughout study ]

Enrollment: 156
Study Completion Date: January 1999
Arms Assigned Interventions
Experimental: 1
Patients who will receive rgp120/HIV-1MN
Biological: rgp120/HIV-1MN
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Experimental: 2
Patients who will receive rgp120/HIV-1SF2
Biological: rgp120/HIV-1 SF-2
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Placebo Comparator: 3
Patients who will receive the placebo counterpart of 120/HIV-1MN
Biological: Placebo version of rgp120/HIV-1MN
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Placebo Comparator: 4
Patients who will receive the placebo counterpart of rgp120/HIV-1SF2
Biological: Placebo version of rgp120/HIV-1SF2
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Detailed 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 patients treated at a given dose level must have received two immunizations without evidence of grade 3 or 4 clinical or laboratory toxicity before dose escalation occurs. Twelve additional patients are treated with the optimal dose of each vaccine at weeks 0, 2, 8, and 20 (An accelerated schedule PER AMENDMENT 3/20/96. Changed from - 0, 4, 8, and 20) accompanied by three additional placebo patients per vaccine. PER AMENDMENT 3/20/96: The optimal dose of rgp120/HIV-1MN is 100 mcg and will be given to the 12 patients and the placebo will be given to 3. The optimal dose of rgp120/HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given to 3.

PER 2/3/95 AMENDMENT: After the initial patients are enrolled, 18 additional newborns will be randomized to one of the three dose levels of rgp120/HIV-1MN (with no placebos). PER AMENDMENT 6/5/95: Another group of 18 newborns will be randomized to one of three treatments representing 3 different doses of the Chiron/Biocine vaccine (with no placebos).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000774


  Show 37 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
Biocine
Investigators
Study Chair: Borkowsky W NYU MEDICAL CENTER
Study Chair: Wara DW UCSF Moffit Hospital
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000774     History of Changes
Other Study ID Numbers: ACTG 230
11207 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
Virus Replication
HIV Envelope Protein gp120
AIDS Vaccines
HIV Preventive Vaccine
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases


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