Clinical trial
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
Name
RV534
Description
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
Trial arms
Trial start
2022-02-18
Estimated PCD
2023-10-16
Trial end
2025-02-28
Status
Active (not recruiting)
Phase
Early phase I
Treatment
HIVIS DNA/MVA-CMDR
HIVIS DNA IM by needle-free injection at weeks 0 and 4 followed by intramuscular (IM) needle injection of 1 X 108 IU/mL (1ml) MVA-CMDR at weeks 24 and 36 in the same arm as HIVIS DNA.
Arms:
Arm 1 (n=10): HIVIS DNA / MVA-CMDR
HIVIS DNA + Cervarix and MVA-CMDR
Cervarix IM by needle injection followed by 1500 micrograms (0.5ml) per injection of HIVIS DNA IM by a needle-free injection device in the skin above (proximal to) the Cervarix injection (within 1.5 cm). They will receive 1 X 108 IU/mL (1ml) MVA-CMDR IM by needle injection at weeks 24 and 36 in the same arm as HIVIS DNA. They will also receive 0.5 ml Cervarix at the time of the first MVACMDR injection in the opposite arm from the MVA injection at week 24.
Arms:
Arm 2 (n=10): HIVIS DNA + Cervarix/ / MVA-CMDR
Cervarix
Cervarix by IM needle injection at weeks 0, 4 and 24.
Arms:
Arm 3 (n=5): Cervarix
Size
25
Primary endpoint
Solicited and unsolicited serious adverse events
through study completion, an average of 1 year
Frequencies of CD4+ T cells that produce Tat/Rev transcription (tat/rev RNA+ cells/106 CD4+ T cells)
Change from Baseline at week 24, 36, 48, 60, 72
HIV DNA (copies/106 CD4+ T cells)
Change from Baseline at week 28, 48
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}
Updated at
2024-05-03
1 organization
3 products
1 indication
Product
HIVIS DNA/MVA-CMDRIndication
HIV InfectionsProduct
Cervarix