JHU ICTR
Johns Hopkins Clinical Research Study

Establishment and Development of the NOD/scid IL-2? Null Humanized Mice Model for the Study of HIV Reservoirs

IRB Number: NA_00093375
Principal Investigator: Brown, Amanda

Study Description:

This research is being done to help develop a cure for HIV infection. Over 35 million people worldwide are living with HIV. There is currently no vaccine or cure available, although promising recent advances in research have given clues about what strategies might be effective. We are developing a small animal model, which can be used to better understand how HIV disrupts the immune system and to test the efficacy of potential vaccines and cures.

Mice cannot normally be infected with the human HIV virus. However, specially made laboratory mice which lack an immune system can be injected with blood cells from the human neonatal umbilical cord and these cells can grow in the mice for their lifespan, generating a functional immune system. This will enable researchers to infect the mice with HIV.

These studies are performed under strictly controlled conditions, under regulations mandated and approved by the Animal Use and Care Committee and by the Office of Animal Law Welfare of the National Institutes of Health. Proper procedures and containment facilities minimize any possibility that laboratory mice are released into the environment.

 



Eligibility Criteria:

Umbilical cords from pregnant women having live births either at risk for sepsis (disseminated bacterial or viral infection) or not at risk may elect to join the research study.

Women will be considered for enrollment during the time of maternal admission for vaginal or cesarean section delivery.

Umbilical cords from women with clinical chorioamnionitis, defined as when the body temperature of the mother is greater than 100.4°F (>38°C) and at least 1 other criterion from those listed below are present are eligible for the research study:

Uterine tenderness (tenderness on palpation)

Foul-smelling amniotic fluid

Maternal tachycardia or rapid heart beat (>100 beats per minute)

Fetal tachycardia or rapid heart beat (>160 beats per minute)

Maternal leukocytosis or abnormal increase in the number of blood cells (>15,000 cells/mm3

Umbilical cords obtained from women having spontaneous preterm birth secondary to pre-term labor or preterm premature rupture of membranes at less than or equal to 34 weeks gestation are eligible for the research study. 

Umbilical cords from infants with inadequate prophylactic antibiotics for Group B Streptococcus (GBS+) or GBS unknown status and with prolonged rupture of membranes (greater than or equal to 18 hrs) are eligible for the research study.

Umbilical cords obtained after perinatal asphyxia (lack of oxygen) defined as a) 5 minute Apgar score <6 or b) the need for intubation and assisted ventilation with continuation for at least 10 min) not readily explained by an obstetric cause such as placental abruption or uterine rupture are eligible for the research study.

Umbilical cords from infants considered at risk for early onset neonatal sepsis soon after birth based on clinical assessment are eligible for the research study.

Umbilical cords from pregnant women with no known infections at the time of delivery, including untreated sexually transmitted disease, untreated GBS or other systemic illnesses and  

Umbilical cords from pregnant women with an absence of a history of prolonged rupture of membranes greater than or equal to 18 hrs and

Umbilical cords from pregnant women with an absence of a history of preterm premature rupture of membranes and

Lack of uncontrollable preterm labor and

Infants with asphyxia (lack of oxygen) secondary to an obstetrical cause may be included and

Umbilical cords from preterm infants delivered secondary to maternal or fetal reasons such as preeclampsia, intrauterine growth restriction, or placental abruption may be included.   



Recruitment Contact Name:Amanda Brown
Contact Phone:410-614-2429
Contact E-Mail: abrown76@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Hospital East Baltimore Campus

Study will provide compensation: No



Keywords:

  • HIV
  • Cord Factors
  • Umbilical Cord
  • Pregnant Women
  • Mice
  • Macrophage Activation
  • T-Lymphocytes
  • Central Nervous System Diseases
  • Immune System
  • AIDS Vaccines
  • Virus Latency