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HIV InfectionsPhase 1NCT00000774

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

A Phase 1 study testing rgp120/HIV-1MN and rgp120/HIV-1 SF-2 in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 day to 3 daysHealthy volunteers can take part
Conditions the study is for
HIV Infections, HIV Seronegativity
What is being tested?
rgp120/HIV-1MN and rgp120/HIV-1 SF-2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
37 sitesin 2 countries
Study dates
Start not givento Jan 1999
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 3 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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:
Show all 13Show fewer
  • > 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.

Who cannot join

  • 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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States36 sites

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 802181088

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland, 212874933

  • Brigham and Women's Hosp., Div. of Infectious Disease

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts, 02118

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 606143394

  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

    Chicago, Illinois, 606371470

  • DUMC Ped. CRS

    Durham, North Carolina, 277103499

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90801

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California, 900951752

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06504

  • Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

    New Orleans, Louisiana, 701122699

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • NJ Med. School CRS

    Newark, New Jersey, 07103

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey

    Paterson, New Jersey

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 191044318

  • Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York, 14642

  • Univ. of Rochester ACTG CRS

    Rochester, New York

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 920930672

  • San Francisco Gen. Hosp.

    San Francisco, California, 94110

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 941430105

  • UW School of Medicine - CHRMC

    Seattle, Washington, 981050371

  • Baystate Health, Baystate Med. Ctr.

    Springfield, Massachusetts, 01199

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 117948111

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York, 13210

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10457

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California, 905022004

  • WNE Maternal Pediatric Adolescent AIDS CRS

    Worcester, New York

Other trials in United States

Puerto Rico1 site

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 009367344

Other trials in Puerto Rico

About this study

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.

Read the 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).

Being tested
rgp120/HIV-1MN, rgp120/HIV-1 SF-2, Placebo version of rgp120/HIV-1MN, Placebo version of rgp120/HIV-1SF2
Keywords
Vaccines, Synthetic, Virus Replication, HIV Envelope Protein gp120, AIDS Vaccines, HIV Preventive Vaccine, HIV Therapeutic Vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rgp120/HIV-1MNBiological

    Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

  • rgp120/HIV-1 SF-2Biological

    Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

  • Placebo version of rgp120/HIV-1MNBiological

    Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

  • Placebo version of rgp120/HIV-1SF2Biological

    Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Study groups in NCT00000774
Study groupRoleWhat they receive
1ExperimentalPatients who will receive rgp120/HIV-1MN
Receives: Biological: rgp120/HIV-1MN
2ExperimentalPatients who will receive rgp120/HIV-1SF2
Receives: Biological: rgp120/HIV-1 SF-2
3Placebo comparatorPatients who will receive the placebo counterpart of 120/HIV-1MN
Receives: Biological: Placebo version of rgp120/HIV-1MN
4Placebo comparatorPatients who will receive the placebo counterpart of rgp120/HIV-1SF2
Receives: Biological: Placebo version of rgp120/HIV-1SF2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines

    Measured: Throughout study

  2. Changes in viral load in infants found to be HIV infected

    Measured: Throughout study

  3. Changes in the slope of absolute CD4 counts in all immunized children

    Measured: Throughout study

Secondary outcomes (1)

  1. Changes in immune response to the vaccine candidates

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionJan 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000774
Sponsor's protocol ID
ACTG 230
Other IDs
11207
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Rogers MF, Mofenson LM, Moseley RR. Reducing the risk of perinatal HIV transmission through zidovudine therapy: treatment recommendations and implications. J Am Med Womens Assoc (1972). 1995 May-Aug;50(3-4):78-82, 93.

    PubMed 7657952

  • Cunningham CK, Wara DW, Kang M, Fenton T, Hawkins E, McNamara J, Mofenson L, Duliege AM, Francis D, McFarland EJ, Borkowsky W; Pediatric AIDS Clinical Trials Group 230 Collaborators. Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women. Clin Infect Dis. 2001 Mar 1;32(5):801-7. doi: 10.1086/319215. Epub 2001 Feb 28.

    PubMed 11229849

  • Borkowsky W, Wara D, Fenton T, McNamara J, Kang M, Mofenson L, McFarland E, Cunningham C, Duliege AM, Francis D, Bryson Y, Burchett S, Spector SA, Frenkel LM, Starr S, Van Dyke R, Jimenez E. Lymphoproliferative responses to recombinant HIV-1 envelope antigens in neonates and infants receiving gp120 vaccines. AIDS Clinical Trial Group 230 Collaborators. J Infect Dis. 2000 Mar;181(3):890-6. doi: 10.1086/315298.

    PubMed 10720509

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rgp120/HIV-1MN and rgp120/HIV-1 SF-2 in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000774, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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