● Recruiting

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

Condition: HIV · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

PhasePhase 1

Planned participants42

Who can joinAll sexes, 18 Years to 55 Years

Healthy volunteersYes

About this study

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).

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (6)

Bridge HIV, San Francisco Department of Public Health	San Francisco, California, United States	Not Yet Recruiting
Ponce de Leon Center CRS	Atlanta, Georgia, United States	Not Yet Recruiting
The Hope Clinic of the Emory Vaccine Research Center; Emory University	Decatur, Georgia, United States	Recruiting
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)	Boston, Massachusetts, United States	Recruiting
Columbia Physicians & Surgeons	New York, New York, United States	Not Yet Recruiting
NY Blood Center CRS	New York, New York, United States	Withdrawn

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Source record: clinicaltrials.gov/study/NCT06796686