The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies

Running, not enrolling · Phase 1

Conditions studied: Chronic HIV Infection

In brief

This is a multicenter controlled interventional trial. This phase 1 trial is the first study to assess 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + aluminum hydroxide suspension (Alum) in people living with HIV (PLWH).

Key facts

Study ID

NCT06006546

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

35

Starts

2024-01-03

Expected to finish

2026-10-27

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
• 18 to 55 years old, inclusive, on day of enrollment.
• Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening.
• On suppressive ART for at least 48 weeks prior to screening. ART is defined as a combination therapy regimen including at least 1 integrase inhibitor and 1 nucleoside reverse transcriptase inhibitor (such as Dovato™) or 2 nucleoside reverse transcriptase inhibitors plus integrase inhibitors. Changes in ARVs for reasons other than virologic failure (eg, tolerability, simplification, different formulation, drug-drug interaction profile) are allowed within 48 weeks prior to screening and up until 6 weeks prior to screening. A fully active alternative ARV regimen is available, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance.
• Plasma HIV RNA < 50 copies/mL (or lower limit of quantitation [LLOQ]) for at least 48 weeks prior to enrollment. NOTE: At least one viral load measurement within 48 weeks prior to the screening visit and another viral load from the screening prior to enrollment visit must be available for review. Two "blips" (ie, plasma HIV-1 RNA > LLOQ and < 400 copies/mL) are allowed if each blip is preceded and followed by values < LLOQ and if the blip(s) occur(s) more than 24 weeks prior to enrollment.
• CD4+ cell count > 450 cells/mm3 and CD4+ cell % ≥ 15% obtained within 40 days prior to enrollment.
• Available for clinic follow-up through the last clinic visit, willing to undergo leukapheresis, and willing to be contacted 12 months after the last study-product administration.
• Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 807 PSRT are required prior to enrollment into HVTN 807.
• In good general health according to the clinical judgment of the site investigator.
• Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
• Total serum calcium of ≥ 8.5 mg/dL.
• Hemoglobin (Hgb):
• ≥ 10.0 g/dL for volunteers who were assigned female sex at birth (AFAB)
• ≥ 11.0 g/dL for cisgender volunteers who were assigned male sex at birth (AMAB) and for transgender men who have been on hormone therapy for more than 6 consecutive months
• ≥ 11.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months
• For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth.
• Absolute neutrophil count (ANC) ≥ 750/mm3
• Platelets ≥ 100,000/mm3
• Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range and direct bilirubin within the institutional range of normal.
• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation.
• For Group 1 volunteers: must agree to consistently use condoms from study week 14 through until viral load post-ATI is undetectable (at a minimum 20 weeks on study, at a maximum 64 weeks on study).
• For Group 1 volunteers
• Persons of pregnancy potential
• Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment.
• Must agree to use effective means of contraception from at least 21 days prior to enrollment until at least 8 weeks post last vaccination and viral load post-ATI is undetectable (at a minimum 20 weeks on study, at a maximum 64 weeks on study).

You may not qualify if…

• Current receipt of ART other than nucleoside reverse transcriptase inhibitor and integrase inhibitor.
• Receipt of long-acting ART within 3 months of enrollment.
• Documented history of resistance to any components of the current ARV regimen.
• Known resistance to 1 or more drugs in 2 or more ARV drug classes. NOTE: M184V/I is an exception and should not be considered when assessing this criterion. Prior HIV resistance testing is not required.
• ART initiation during acute HIV-1 infection (defined as within 1 year of HIV-1 acquisition, if known).
• History of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers.
• History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy.
• History of HIV-related illness under US Centers for Disease Control (CDC) Category C (except for recurrent pneumonia) within 10 years prior to screening, based on available medical history and assessed by the Investigator for clinical relevance. Anyone with a history of CD4 < 200 cells/mm3 on one or more occasions, based on available medical history and assessed by the Investigator for clinical relevance. Documentation of every case with history of CD4 < 200 cells/mm3 must be provided to the Sponsor and PSRT, who will determine eligibility on a case-by-case basis. NOTE: History of treated and resolved pulmonary tuberculosis (TB) will not be exclusionary.
• Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to enrollment or for whom such therapies are expected in the subsequent 12 months. NOTE: Minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) is not exclusionary.
• Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg), hepatitis C antibody without documented history of prior treatment and clearance, or hepatitis C virus RNA (HCV-RNA) in blood.
• Diagnosis of cirrhosis.
• Current untreated or incompletely treated active TB disease or untreated latent TB infection. NOTE: Individuals who are on treatment for latent TB with at least 4 weeks of treatment completed are not excluded.
• Volunteer who is breastfeeding or pregnant.
• Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
• Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the PSRT on a case-by-case basis
• History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, including a previous diagnosis of any of the following:
• Acute myocardial infarction
• Acute coronary syndromes
• Stable or unstable angina
• Coronary or other arterial revascularization
• Stroke
• Transient ischemic attack
• Peripheral arterial disease presumed to be of atherosclerotic origin
• Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
• Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) emergency use listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.

Where it is running

• Birmingham — Birmingham, Alabama, United States
• Atlanta- Ponce — Atlanta, Georgia, United States
• The Hope Clinic of the Emory Vaccine Center CRS (Site #31440) — Decatur, Georgia, United States
• BIDMC — Boston, Massachusetts, United States
• Columbia P&S CRS Site#30329 — New York, New York, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States
• Seattle Vaccine and Prevention CRS (Site # 30331) — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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