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

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).

Eligibility

Age range

18–55 years

Sex

All

Healthy volunteers

Yes

Interventions

• 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

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