Trials / Recruiting
RecruitingNCT06796686
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
A Phase 1 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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 426c.Mod.Core-C4b | 426c.Mod.Core-C4b is supplied at a concentration of 2 mg/mL, 0.55 mL per vial. |
| BIOLOGICAL | HxB2.WT.Core-C4b | HxB2.WT.Core-C4b is supplied at a concentration of 1 mg/mL, 0.5 mL per vial |
| BIOLOGICAL | 3M-052-AF adjuvant | immune response modifier (IRM) |
| OTHER | Aluminum hydroxide suspension (Alum) adjuvant | Alhydrogel. |
| OTHER | Diluent | Tris-NaCl buffer |
Timeline
- Start date
- 2025-03-17
- Primary completion
- 2027-01-15
- Completion
- 2027-01-15
- First posted
- 2025-01-28
- Last updated
- 2025-09-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06796686. Inclusion in this directory is not an endorsement.