This Phase 1 study will evaluate the safety, tolerability, and immune responses of investigational CH505 HIV vaccine regimens in adults in overall good health without HIV. Participants will receive CH505 protein nanoparticle vaccines (DV901-NP) formulated with the investigational adjuvant ACU-026-001-1, followed by either CH505 protein nanoparticle (DV902-NP) or CH505 mRNA vaccine boosters. The study will assess the ability of these regimens to induce HIV-specific immune responses, including B-cell responses associated with the development of broadly neutralizing antibodies. An immunology cohort will also evaluate how the location of booster vaccination affects immune responses.
Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
At least 18 years old at screening and up to 55 years old on day of enrollment.
Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last study product administration of ACU-026-001-1.
Willing to undergo study procedures as outlined in the schedule of procedures.
Woman who is breastfeeding or pregnant.
Body mass index (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by approval.
Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is ≤8% within the last 6 months (sites may draw these at screening).
Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
Sequential
DV901-NP
Biological/VaccineCH505 HIV-1 envelope protein nanoparticle vaccine administered intramuscularly at doses of 100 mcg, 150 mcg, or 300 mcg, depending on study group. Administered with ACU-026-001-1 adjuvant.
DV902-NP
Biological/VaccineCH505 HIV-1 envelope protein nanoparticle booster vaccine administered intramuscularly at doses of 100 mcg or 300 mcg with ACU-026-001-1 adjuvant.
CH505 TF mRNA-gp160
Biological/VaccineCH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Weeks 16 and 24.
CH505 w24 mRNA-gp160
Biological/VaccineCH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Week 32.
ACU-026-001-1
Biological/VaccineInvestigational lipid nanoparticle adjuvant administered in combination with DV901-NP or DV902-NP. Dose is 2 mg for Groups 1-3 and 1 mg for Groups 4-5.
Incidence of solicited local reactogenicity
Incidence and severity of solicited local reactogenicity following study vaccination.
Incidence of solicited systemic reactogenicity
Incidence and severity of solicited systemic reactogenicity following study vaccination.
Incidence of adverse events
Incidence of adverse events following study vaccination.
Incidence of serious adverse events
Incidence of serious adverse events (SAEs).
Response rate of HIV Env-specific serum IgG binding antibodies
Magnitude of HIV Env-specific serum IgG binding antibodies as measured by binding Ab multiplex assay (BAMA)
Epitope specificity of HIV Env-specific serum IgG binding antibodies
Response rate of ferritin-specific serum IgG binding antibodies
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