Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections

In brief

A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).

Key facts

Study ID

NCT04983030

Run by

Boris Juelg, MD PhD

People needed

28

Starts

2022-04-01

Expected to finish

2026-02-23

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each potential study participant must pass the Test of Understanding (TOU), indicating that he or she understands the purpose of, and procedures required for the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and has answered the potential study participant's questions. Each study participant must subsequently sign the ICF, indicating that he or she is willing to participate in the study.
• Each study participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Study participants are ≥18 to ≤70 years old on the day of signing the ICF.
• Each study participant must have documented HIV-1 infection.
• Must be on suppressive ART for at least 48 weeks prior to screening. ART is defined as a combination therapy regimen including at least 2 compounds, e.g., integrase inhibitor and nucleoside reverse transcriptase inhibitors (such as DovatoTM) or more than 2 compounds, e.g., 2x nucleoside reverse transcriptase inhibitors plus integrase inhibitor.
• Must have a plasma HIV RNA <50 cps/mL at screening and at least 1 documented evidence of plasma HIV RNA <50 cps/mL after the last ART change.
• Must be willing to undergo ATI.
• Must be medically stable as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening, and as per the investigator's discretion.
• Ability and willingness to restart ART according to study guidelines.
• Each study participant must meet the following laboratory criteria prior to randomization:
• Hemoglobin: Women ≥10.5 g/dL; Men ≥11.0 g/dL
• White cell count: 2,500 to 11,000 cells/mm3, inclusive
• Absolute neutrophil count: >1,000 cells/mm3
• Platelets: 125,000 to 450,000 per mm3, inclusive
• Screening serum liver enzymes (e.g., alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin): within the normal reference ranges at baseline
• Creatinine: <1.2 x ULN
• Estimated glomerular filtration rate ≥ 60 mL/min
• CD4+: >450 cells/mm3 at screening and at least 1 documented result >300 cells/mm3 during 48 weeks before randomization (for nadir, see exclusion criterion 9)
• Troponin: <1 x ULN
• For participants who are able to become pregnant, negative serum or urine pregnancy test (with a sensitivity of 15-25 mIU/mL) within 24 hours prior to Stage 1 randomization
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction starting from the first vaccination at Week 0 visit and for a period of 24 weeks after last dose of bNAb.

You may not qualify if…

• Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
• Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws eg, bleeding disorders. NOTE: nonsteroidal anti- inflammatory drugs (NSAIDS) and acetylsalicylic acid containing preparations have to be stopped for 5 days before and after planned leukapheresis.
• Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0oC within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted.
• Any history of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma, or virus-associated cancers.
• Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months prior to Stage 1 randomization or for whom such therapies are expected in the next 12 months (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
• Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the study participant.
• History or current clinical atherosclerotic cardiovascular disease, as defined by 2013 American College of Cardiology (ACC)/American Heart Association (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
• TIA
• Peripheral arterial disease presumed to be of atherosclerotic origin
• Anyone with a history of HIV-related illness under 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 repeated CD4+ <200 cells/mm3, based on available medical history and assessed by the investigator for clinical relevance. .
• Current receipt of ART other than nucleoside reverse transcriptase inhibitor and integrase inhibitor.
• Anyone who had major surgery (per the investigator's judgment), within 12 weeks before dosing, or has not have fully recovered from surgery, or has surgery planned during the time the study participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
• Anyone with a history of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up).
• Anyone with an ECG with reading and showing clinically significant findings, or features that would interfere with the assessment of myocarditis/pericarditis.
• Current advanced liver disease (non-alcoholic fatty liver disease, steatohepatitis, or alcoholic liver disease) with known or suspected cirrhosis or fibrosis score ≥F2.
• Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive, HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV infection) or syphilis infection that has not been effectively treated. Positive syphilis serology due to past effectively treated infection is not exclusionary.
• Anyone with active, untreated gonorrhea or chlamydia infection will be referred to a clinician for appropriate treatment. If chlamydia and/or gonorrhea treatment is successfully completed, the participant is eligible for a repeat gonorrhea or chlamydia screening test and potential study entry.
• Anyone with thyroidectomy or active thyroid disease requiring medication during the last 12 months (Not excluded: a stable thyroid supplementation).
• Anyone with history of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy.

Where it is running

• UCLA CARE (Center for AIDs Research and Education) — Los Angeles, California, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University Clinical Trials Unit — St Louis, Missouri, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Washington Positive Research — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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