PedMAb1
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202205715278722
- Lead Sponsor
- South African Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 72
Mother
• Greater than or equal to 18 years of age
• Documented HIV-1 infection
• Breastfeeding at the time of consenting or willing to initiate breastfeeding in the immediate post partum period.
• Able and willing to provide a signed informed consent form to participate in the study for herself and her infant.
Newborn
• Alive infant with a birth weight greater than or equal to 2.0 kg and lower than or equal to 4.0kg
• Gestational age greater or equal to 36 weeks, assessed using birth Ballard Score (done up to 42 hours after birth)
• Written consent of the one or both parents (according to South African regulation)
Mother
• Prior participation in any HIV-1 vaccine trial
• Receipt of any other active or passive HIV immunotherapy or investigational product concurrently
• Documented or suspected serious medical illness with fetal compromise or immediate life-threatening condition (other than HIV-infection as judged by the examining clinician)
• Most recent CD4 count (within a time frame of =6 months) under 350 cells/mm3
• Mother not on ART
• Unable or not willing to breastfeed
• Active tubercolosis
• COVID-19 diagnosis in the past month
• Plan to relocate in 1 year
• Mother does not have her own cell phone
• Mother not able to provide three alternate contact phone numbers
Newborn
• HIV-infected on birth PCR
• Receipt of or anticipated need for blood product, immunoglobulin or immunosuppressive therapy. This includes infants who require hepatitis B immunoglobulins (HBIG) but not infants who receive hepatitis B vaccine in the new-born period
• Documented or suspected serious medical or immediate life-threatening condition
• Infant in ICU or high care requiring supplemental oxygen at time of first bNAb dose
• Known allergy to study drug or components
• Multiple birth, i.e. twins, triplets, quadruplets, etc
• Baseline laboratory results:
• Haemoglobin level less than 12.0 g/dL
• Platelet count less than 100,000 cells/mm3
• Absolute neutrophil count: for infants less than 24 hours old, less than 4,000 cells/mm3; for infants greater than 24 hours old, less than 1,250 cells/mm3
• Serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT) greater than or equal to 1.25 times upper limit of age-adjusted normal.
• Serum bilirubin at a level needing phototherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety (adverse events) until day 28 after a single SC administration of one bNAb, tested at increasing doses within 72 hours of birth, in breastfeeding HEU neonates (arms 1 through 5).;To evaluate the safety (adverse events) until day 28 after two single SC administration of two bNAbs, tested at increasing doses within 72 hours of birth, in breastfeeding HEU neonates (arms 6 and 7).;To evaluate the safety (adverse events) until day 28 after two single SC administrations of two bNAbs, within 72 hours of birth and repeated at 2 months (arms 6b and 7b) or at a time point between 3 and 6 months (arms 8 and 9) (to be defined according to PK data (from analysis of the previous arms) in breastfeeding HEU neonates
- Secondary Outcome Measures
Name Time Method To evaluate the PK profile up to 6 months of each single bNAb administered, alone or in combination, at different doses within 72 hours of birth in breastfeeding HEU neonates (arms 1 through 5).;To evaluate the PK profile up to 6 months of bNAbs administered in combination, at different doses within 72 hours of birth in breastfeeding HEU (arms 6 and 7).;To evaluate the PK profile up to 6 months of each bNAb, administered in combination, in breastfeeding HEU infants after a second administration at 2 months (arms 6/6b and 7/7b) or at a time point between 3 and 6 months (arms 8 and 9).;To assess safety (adverse events) up to 6 months after each single bNAb (arms 1 to 5) or after the combined bNAbs administration (arms 6 through 9).