Search / Trial NCT00001046

Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)

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

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Trial Information

Current as of July 14, 2024

Withdrawn

Keywords

Vaccines, Synthetic Pregnancy Pregnancy Complications, Infectious Aids Related Complex Hiv Envelope Protein Gp120 Hiv Preventive Vaccine Hiv Therapeutic Vaccine

Description

Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers. Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients...

Gender

Female

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed during pregnancy:
  • AZT.
  • Methadone maintenance.
  • NOTE:
  • Patients may not initiate antiretroviral therapy for disease progression.
  • NOTE:
  • Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
  • Patients must have:
  • Documented HIV infection.
  • CD4 count >= 400 cells/mm3 (average of two determinations obtained 1 week apart).
  • No clinical criteria for a diagnosis of AIDS.
  • HIV p24 antigen <= 30 pg/ml.
  • Estimated gestational age between 16 and 24 weeks, confirmed by baseline sonogram that does not demonstrate any congenital abnormalities considered to be incompatible with life.
  • Intention to carry pregnancy to term.
  • Willingness to be followed by an ACTU for the duration of the study.
  • NOTE:
  • Father of the fetus (if available after a reasonable attempt to contact him) must provide informed consent.
  • Prior Medication:
  • Allowed:
  • AZT.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known hypersensitivity to a component of the vaccine.
  • Hepatitis B antigen positive at study entry.
  • Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome).
  • Evidence of syphilis that requires therapy during this pregnancy.
  • Intention to breast-feed.
  • Presence of obstetrical high-risk factors such as:
  • insulin-dependent diabetes
  • hypertension requiring the use of anti-hypertensive therapy
  • repeated intrauterine fetal demise
  • Rh-sensitization or other blood group alloimmunization
  • diseases requiring use of immunosuppressive therapy (e.g., asthma, lupus).
  • Concurrent Medication:
  • Excluded during pregnancy:
  • Antiretrovirals other than AZT.
  • Immunomodulating agents (e.g., HIVIG, IVIG).
  • Other investigational drugs or immunosuppressive agents.
  • NOTE:
  • Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
  • Prior Medication:
  • Excluded within 90 days prior to study entry:
  • Antiretrovirals other than AZT.
  • Immunomodulating agents (e.g., HIVIG, IVIG).
  • Current use of illicit drugs or chronic alcohol use by patient history.

Attachments

readout_NCT00001046_2024-07-14.pdf

4.5 MB

NCT00001046_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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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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?

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