Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
Inclusion Criteria:1. 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. 2. Each study participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 3. Study participants are ≥18 to ≤70 years old on the day of signing the ICF. 4. Each study participant must have documented HIV-1 infection. 5. 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. 6. 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. 7. Must be willing to undergo ATI. 8. 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. 9. Ability and willingness to restart ART according to study guidelines. 10. 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.
Exclusion Criteria:1. Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study. 2. 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. 3. 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. 4. Any history of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma, or virus-associated cancers. 5. 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). 6. 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. 7. 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.
- - within 28 days before or after planned administration of any of the study products.
- - within 14 days before or after planned administration of any of the study products.
- - within 28 days before or after planned administration of any of the study products.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Boris Juelg, MD PhD|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Boris D Juelg, MD PHD|
|Principal Investigator Affiliation||Beth Israel Deaconess Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Other, Industry, NIH|
The disease, disorder, syndrome, illness, or injury that is being studied.
|HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections|
The study will enroll 36 adults randomized in a 1:1:1 ratio to 3 groups (vaccines+ bNAbs, vaccine+placebo, placebo+bNAbs), respectively. The study population will include HIV-infected adults who are on suppressive ART for at least 48 weeks prior to screening. The study comprises of a screening period of 10 weeks (Stage 0), a 24-week vaccination and follow-up period (Stage 1), a 4-week bNAb administration period and a 20-week bNAb washout period (Stage 2), and a 24-week monitoring period (Stage 3). An analytical antiretroviral treatment interruption (ATI) to assess rates of sustained virologic suppression will be conducted during Stages 2-3. Participants will record solicited signs and symptoms in a diary on the evening after each study drug administration and then daily for the next 7 days. Further safety evaluations will include monitoring of AEs, physical examinations, vital sign measurements, clinical laboratory tests (including urinalysis, CD4 count and HIV RNA), and for women, also pregnancy testing. Blood samples will be taken at specific clinic visits to assess immune and virologic responses as well as the pharmacokinetics and pharmacodynamics of bNAbs.
Experimental: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs
Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28.
Active Comparator: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo
Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. Placebo will be administered at week 24, and at week 28.
Active Comparator: Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs
Participants will receive Placebo at week 0 and 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28.
Biological: - Ad26.Mos4.HIV
Ad26.Mos4.HIV is a tetravalent vaccine containing Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins.
Biological: - MVA-BN-HIV
MVA-BN-HIV is a monovalent vaccine comprising a single Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN®) vector encoding Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins.
Biological: - PGT121
PGT121 is a human mAb that targets the HIV-1 V3 glycan, centered on N332.
Biological: - PGDM1400
PGDM1400 is a human mAb that targets the HIV-1 V2 glycan, centered on N160.
Biological: - VRC07-523LS
VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.