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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

NCT04301154

CompletedPhase 1

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Conditions: HIV Infections

Interventions: HIVIS DNA/MVA-CMDR, HIVIS DNA + Cervarix and MVA-CMDR, Cervarix

Countries: South Africa

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 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Eligibility overview

Sex: ALL

Age: 9 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

1. HIV perinatally infected
2. Know their HIV+ status
3. Initiated ART prior to 6 months of age
4. Male and female ≥ 9 years old
5. In generally good health
6. Plasma viral load \< 200 copies/ml on ART at screening
7. CD4 count above 400 cells/mm3 at screening
8. Participants of childbearing potential who are sexually active must be willing to practice effective contraception during the study
9. Negative urine β-HCG (human chorionic gonadotropin) pregnancy test for any female of childbearing age (post-menarche)
10. Availability for follow-up for planned duration of the study
11. 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.
12. 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.
13. 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:

1. Participants who experienced virological failure necessitating ART modifications
2. Participants who had ART interruption that lasted \>2 weeks
3. Prior or current pancreatitis or history of alcohol abuse.
4. Systemic cortisone treatment within the past 30 days
5. Participants coinfected with chronic hepatitis B (Hepatitis B surface antigen, HBsAg+) or hepatitis C (Hepatitis C antibody, HCV Ab+) at screening
6. Participants with signs of autoimmune diseases
7. Participants with history of myocarditis
8. Participants on any immune modulating or investigational drug
9. Pregnant or breastfeeding female

Locations (1)

Tygerberg Hills, Cape Town, South Africa