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

Keywords

ClinConnect Summary

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.

Trial Officials