Status:
COMPLETED
Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Bambino Gesù Hospital and Research Institute
PENTA Foundation
Conditions:
HIV Infections
Eligibility:
All Genders
9+ years
Phase:
PHASE1
Brief Summary
Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Ag...
Detailed Description
HIVIS DNA and MVA-CMDR vaccines induce immune responses important for clearing infected cells: broad HIV-specific CD8+ cytotoxic T cells, potent antibodydependent cellular cytotoxicity (ADCC), and bin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- HIV perinatally infected
- Know their HIV+ status
- Initiated ART prior to 6 months of age
- Male and female ≥ 9 years old
- In generally good health
- Plasma viral load \< 200 copies/ml on ART at screening
- CD4 count above 400 cells/mm3 at screening
- Participants of childbearing potential who are sexually active must be willing to practice effective contraception during the study
- Negative urine β-HCG (human chorionic gonadotropin) pregnancy test for any female of childbearing age (post-menarche)
- Availability for follow-up for planned duration of the study
- Passing a test of understanding is required for participants ≥ 18 years old or the parent(s)/legal representative of participants \< 18 years old before consent.
- Written informed consent from participants ≥ 18 years old or parent(s)/legal representative of participants \< 18 years old. Assent by participants aged 9-17 years old will also be required.
- Laboratory criteria within 8 weeks prior to enrollment
- Hb \>11.0 g/dl
- White blood cell count \>3000 cells/mm3
- Platelets \>125,000/ mm3
- ALT \<1.5 x upper limit of normal
- Creatinine \<1.5 x upper limit of normal
- Exclusion criteria:
- Participants who experienced virological failure necessitating ART modifications
- Participants who had ART interruption that lasted \>2 weeks
- Prior or current pancreatitis or history of alcohol abuse.
- Systemic cortisone treatment within the past 30 days
- Participants coinfected with chronic hepatitis B (Hepatitis B surface antigen, HBsAg+) or hepatitis C (Hepatitis C antibody, HCV Ab+) at screening
- Participants with signs of autoimmune diseases
- Participants with history of myocarditis
- Participants on any immune modulating or investigational drug
- Pregnant or breastfeeding female
Exclusion
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04301154
Start Date
February 18 2022
End Date
October 16 2023
Last Update
August 11 2025
Active Locations (1)
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1
Stellenbosch University
Tygerberg Hills, Cape Town, South Africa, 7505