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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
54
CH505 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.
CH505 HIV-1 envelope protein nanoparticle booster vaccine administered intramuscularly at doses of 100 mcg or 300 mcg with ACU-026-001-1 adjuvant.
CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Weeks 16 and 24.
CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Week 32.
Investigational 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.
Bridge HIV CRS Site# 30305
San Francisco, California, United States
The Ponce de Leon Center CRS Site# 5802
Atlanta, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Site# 30007
Boston, Massachusetts, United States
BIDMC VCRS Site# 32077
Boston, Massachusetts, United States
University of Rochester Vaccines to Prevent HIV Infection CRS Site# 31467
Rochester, New York, United States
Penn Prevention CRS Site# 30310
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS Site# 1001
Pittsburgh, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS Site# 30352
Nashville, Tennessee, United States
Incidence of solicited local reactogenicity
Incidence and severity of solicited local reactogenicity following study vaccination.
Time frame: Through 14 days after each study vaccination
Incidence of solicited systemic reactogenicity
Incidence and severity of solicited systemic reactogenicity following study vaccination.
Time frame: Through 14 days after each study vaccination
Incidence of adverse events
Incidence of adverse events following study vaccination.
Time frame: Through 30 days after each study vaccination
Incidence of serious adverse events
Incidence of serious adverse events (SAEs).
Time frame: Through 52 weeks after the last study vaccination
Incidence of medically attended adverse events
Incidence of medically attended adverse events (MAAEs).
Time frame: Through 52 weeks after the last study vaccination
Incidence of adverse events of special interest
Incidence of adverse events of special interest (AESIs)
Time frame: Through 52 weeks after the last study vaccination
Incidence of adverse events leading to permanent discontinuation of study product or participant withdrawal
Incidence of adverse events resulting in permanent discontinuation of study product administration or participant withdrawal.
Time frame: Through 52 weeks after the last study vaccination
Frequency of CH505M5.G458Y/GnT1neg-specific IgG+ memory B cells
Frequency of CH505M5.G458Y/GnT1neg-specific IgG+ memory B cells measured by flow cytometry.
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of precursor-specific serum neutralizing antibodies
Response rate of differential serum neutralizing antibody activity against precursor detection viruses and corresponding epitope knockout viruses measured by TZM-bl assay.
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of precursor-specific serum neutralizing antibodies
Magnitude of differential serum neutralizing antibody activity against precursor detection viruses and corresponding epitope knockout viruses measured by TZM-bl assay.
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of HIV Env-specific serum IgG binding antibodies
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of HIV Env-specific serum IgG binding antibodies as measured by binding Ab multiplex assay (BAMA)
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Epitope specificity of HIV Env-specific serum IgG binding antibodies
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of ferritin-specific serum IgG binding antibodies
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of ferritin-specific serum IgG binding antibodies as measured by binding Ab multiplex assay (BAMA)
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Epitope specificity of ferritin-specific serum IgG binding antibodies
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
Epitope-specific antibody responses measured by EMPEM
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of antibodies blocking soluble CD4 binding to HIV Env
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
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Magnitude of antibodies blocking soluble CD4 binding to HIV Env as measured by competition ELISA
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of antibodies blocking CH235.12 binding to HIV Env
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of antibodies blocking CH235.12 binding to HIV Env as measured by competition ELISA
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of serum neutralization against the broadly neutralizing antibody maturation panel
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of serum neutralization against the broadly neutralizing antibody maturation panel as measured by TZM-bl assay
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of serum neutralization against heterologous Tier 2 HIV-1 strains
Time frame: Two weeks after the fourth vaccination (Groups 1 and 2); two weeks after the fourth and fifth vaccinations (Group 3)
Magnitude of serum neutralization against heterologous Tier 2 HIV-1 strains
Time frame: Two weeks after the fourth vaccination (Groups 1 and 2); two weeks after the fourth and fifth vaccinations (Group 3)
Frequency of CH235-like B-cell receptor sequences
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Frequency of other CD4 binding site-like B-cell receptor sequences
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of heterologous CD4 binding site Env-specific IgG+ B cells
Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of antibodies blocking DH1029 binding to HIV Env
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of antibodies blocking DH1029 binding to HIV Env as measured by competition ELISA
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Response rate of antibodies blocking RM19R binding to HIV Env
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Magnitude of antibodies blocking RM19R binding to HIV Env as measured by competition ELISA
Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)
Plasmablast response using B-cell sorting, single-cell RT-PCR, 10x genomics RNA sequencing
Time frame: One week after the second and third vaccinations (Groups 4 and 5)
Vaccine-specific Germinal center B-cell clonality using single cell sorting against vaccine antigen and determination of BCR sequences
Time frame: One week after the second vaccination and 3 weeks after the third vaccination (Groups 4 and 5)
Vaccine-specific Germinal center relative B-cell receptor somatic hypermutation using single cell sorting against vaccine antigen and determination of BCR sequences
Time frame: One week after the second vaccination and 3 weeks after the third vaccination (Groups 4 and 5)
Vaccine-specific Peripheral B-cell clonal diversity using single-cell sorting against vaccine antigen and determination of BCR sequences via NGS
Time frame: Prior to and 9 weeks after the third vaccination (Groups 4 and 5)
Vaccine-specific Peripheral relative B-cell receptor somatic hypermutation using single-cell sorting against vaccine antigen and determination of BCR sequences via NGS
Time frame: Prior to and 9 weeks after the third vaccination (Groups 4 and 5)
Response rate of HIV Env-specific serum IgG binding antibodies following homologous boosting
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Magnitude of HIV Env-specific serum IgG binding antibodies following homologous boosting as measured by BAMA
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Epitope specificity of HIV Env-specific serum IgG binding antibodies following homologous boosting
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Response rate of ferritin-specific serum IgG binding antibodies following homologous boosting
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Magnitude of ferritin-specific serum IgG binding antibodies following homologous boosting as measured by BAMA
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Epitope specificity of ferritin-specific serum IgG binding antibodies following homologous boosting
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Response rate of precursor-specific serum neutralizing antibodies following homologous boosting
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)
Magnitude of precursor-specific serum neutralizing antibodies following homologous boosting as measured by TZM-bl assay
Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)