Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06796686
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 426c.Mod.Core-C4b — BIOLOGICAL
    426c.Mod.Core-C4b is supplied at a concentration of 2 mg/mL, 0.55 mL per vial.
  • HxB2.WT.Core-C4b — BIOLOGICAL
    HxB2.WT.Core-C4b is supplied at a concentration of 1 mg/mL, 0.5 mL per vial
  • 3M-052-AF adjuvant — BIOLOGICAL
    immune response modifier (IRM)
  • Aluminum hydroxide suspension (Alum) adjuvant — OTHER
    Alhydrogel.
  • Diluent — OTHER
    Tris-NaCl buffer

Study Details

This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).

Key Dates

Start date
Mar 17, 2025
Status verified
Sep 2025
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group 1
    One fractional dose of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b
  • Active Comparator: Group 2A
    One fractional dose and one bolus dose of 426c.Mod.Core-C4b two bolus doses of HxB2.WT.Core-C4b
  • Active Comparator: Group 2B
    One split dose and one bolus of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

Primary Outcome Measure

Incidence of Local Signs and Symptoms within 14 Days Post-Vaccination [ Time Frame: Within 14 days of receiving study vaccine ]

Locations (6)

FacilityCityStateZIPSite coordinators
Bridge HIV, San Francisco Department of Public HealthSan FranciscoCalifornia94102
Emily Schaeffer
[email protected]
628-217-7456
Ponce de Leon Center CRSAtlantaGeorgia30308
Ericka Patrick, RN, MSN
[email protected]
404-616-6313
The Hope Clinic of the Emory Vaccine Research Center; Emory UniversityDecaturGeorgia30030
Emily Osbourne
[email protected]
404-712-1370
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)BostonMassachusetts02115
Jose Licona
[email protected]
617-525-9433
Columbia Physicians & SurgeonsNew YorkNew York10032
Anyelina Cantos
[email protected]
212-305-2201
NY Blood Center CRSNew YorkNew York10065-

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
Bridge HIV, San Francisco Department of Public Health· San Francisco, CAPonce de Leon Center CRS· Atlanta, GAThe Hope Clinic of the Emory Vaccine Research Center; Emory University· Decatur, GABrigham and Women's Hospital Vaccine CRS (BWH VCRS)· Boston, MAColumbia Physicians & Surgeons· New York, NYNY Blood Center CRS· New York, NY

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