This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.
Able and willing to provide informed consent.
Age 18 to 60 years.
Documented HIV infection.
Lowest (nadir) CD4+ count between 250 and 450 cells/mm³.
Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Use of long-acting ART within 3 months prior to enrollment.
Known resistance to any component of the current ART regimen (excluding M184V/I mutation).
Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation).
Sequential
DV700P-RNA 100 mcg
Biological/VaccineIntramuscular injection
DV701B1.1-RNA 100 mcg
Biological/VaccineIntramuscular injection
Local reactogenicity following study product administration
Incidence and severity of solicited local reactogenicity signs and symptoms (injection site pain, erythema, and swelling), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
Systemic reactogenicity following study product administration
Incidence and severity of solicited systemic reactogenicity signs and symptoms (fever, fatigue, myalgia, arthralgia, headache, chills, nausea), graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
Number and description of serious adverse events (SAEs)
Number and description of medically attended adverse events (MAAEs)
Frequency of Env-specific and V3-glycan-specific B cells
Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing
Frequency of Env-specific and V3-glycan-specific B cells after last vaccination and after ART restart
Frequency of total Env-specific and V3-glycan-specific B cells, as assessed by flow cytometry
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences after last vaccination and after ART restart
Frequency of mutation of V3-glycan-specific B-cell receptor (BCR) sequences, as assessed by B-cell sorting and BCR sequencing
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Department of Health and Human Services
Collaborator
Duke University
Collaborator