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)
MF59
+ rgp120/HIV-1 SF-2
Infecciones Transmitidas por la Sangre+15
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Prevención
Resumen
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 may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 40 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.