HIVPhase 1/2NCT04983030
Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults
A Phase 1/2 study testing Ad26.Mos4.HIV, MVA-BN-HIV and PGT121 in people with HIV and Acquired Immunodeficiency Syndrome, run by Boris Juelg, MD PhD at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired
- What is being tested?
- Ad26.Mos4.HIV, MVA-BN-HIV and PGT121
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2022to 23 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Anyone who has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the study participant's safety and/or compliance with the study procedures.
- Anyone with a history of thrombosis with thrombocytopenia syndrome (TTS), or Heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)
- Anyone who received treatment with immunoglobulins in the 2 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study. Prior recipients of anti-HIV bNAbs, independently of the timing, are excluded.
- Anyone who received or plans to receive:
- licensed live attenuated vaccines - within 28 days before or after planned administration of any of the study products.
- other licensed (not live) vaccines - within 14 days before or after planned administration of any of the study products.
- SARS-CoV-2 vaccines under Emergency Use Authorization (EUA) by the FDA - within 28 days before or after planned administration of any of the study products.
- Anyone who received an investigational drug (not under EUA by the FDA) or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine. Receipt of prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary.
- Anyone who is currently enrolled or plans to participate in another investigational study during the course of this study.
- Anyone who has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines) and specifically to neomycin or streptomycin or egg products.
- Anyone with a history of chronic urticaria (recurrent hives) or a history of chronic or recurrent eczema and/or atopic dermatitis.
- Anyone with abnormal function of the immune system resulting from:
- Clinical conditions (e.g., autoimmune disease or immunodeficiency that are not HIV related).
- Chronic or recurrent use of systemic corticosteroids.
- Administration of antineoplastic and immunomodulating agents or radiotherapy.
- Anyone with history of acute polyneuropathy(e.g.,Guillain-Barré syndrome).
- Anyone who cannot communicate reliably with the investigator.
- Known resistance to 1 or more drugs in 2 or more ARV drug classes.
- Weight >115kg.
- Anyone who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study, or is unlikely to complete the full course of vaccination and observation.
- Any employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor (or its partners).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UCLA CARE (Center for AIDs Research and Education)
Los Angeles, California, 90035
Orlando Immunology Center
Orlando, Florida, 32803
University of Washington Positive Research
Seattle, Washington, 98104
Washington University Clinical Trials Unit
St Louis, Missouri, 63110
About this study
Official title: A Safety, Immunogenicity and Efficacy Phase 1/2a Study of a Heterologous Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Regimen Plus Broadly Neutralizing Antibodies PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults on Suppressive ART
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).
Read the detailed description
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.
- Conditions
- HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections
- Being tested
- Ad26.Mos4.HIV, MVA-BN-HIV, PGT121, PGDM1400, VRC07-523LS
- Keywords
- Monoclonal antibodies, Therapeutic vaccination, Analytical treatment interruption, HIV, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral, Retroviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.Mos4.HIVBiological
Ad26.Mos4.HIV is a tetravalent vaccine containing Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins.
MVA-BN-HIVBiological
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.
PGT121Biological
PGT121 is a human mAb that targets the HIV-1 V3 glycan, centered on N332.
PGDM1400Biological
PGDM1400 is a human mAb that targets the HIV-1 V2 glycan, centered on N160.
VRC07-523LSBiological
VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site.
| Study group | Role | What they receive |
|---|---|---|
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | Experimental | 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. Receives: Biological: Ad26.Mos4.HIV; Biological: MVA-BN-HIV; Biological: PGT121; Biological: PGDM1400; Biological: VRC07-523LS |
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo | Active comparator | 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. Receives: Biological: Ad26.Mos4.HIV; Biological: MVA-BN-HIV |
| Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | Active comparator | 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. Receives: Biological: PGT121; Biological: PGDM1400; Biological: VRC07-523LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Measured: 7 days post-investigational product administration
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Measured: 7 days post-investigational product administration
Percentage of Participants With Unsolicited AEs as a Measure of Safety and Tolerability
An Unsolicited AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Approximately up to 72 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
AESIs and potential AESIs are judged to be of special interest because of clinical importance, known or suspected class effects and include thrombotic events and symptomatic thrombocytopenia.
Measured: From first vaccination until 6 months after last vaccination.
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Measured: Up to post-vaccination follow-up period until Week 72
Total IgG and Subclass Specific Antibody Titer
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Measured: Up to post-vaccination follow-up period until Week 72 ]
Antiviral activity - Percentage of participants who maintain plasma HIV RNA <1000 copies/mL
Proportion of participants who remain off ART and maintaining plasma HIV RNA <1000 copies/mL for at least two thirds of the time between 24 and 72 weeks of analytical treatment interruption (ATI).
Measured: Time between week 24 and week 72 week
Secondary outcomes (6)
Measurement of the HIV-1 reservoir (dQVOA)
Measurement of the HIV-1 reservoir by differential quantitative viral outgrowth assay
Measured: At baseline, Week 24 and Week 32
Measurement of intact proviral DNA
Measurement of intact proviral DNA, ie by intact proviral DNA assay (IPDA)
Measured: At baseline, Week 24 and Week 32
Compare the time to viral rebound (defined as confirmed plasma HIV RNA levels ≥1,000 copies/mL) following Ad26.Mos4.HIV, MVA-BN-HIV and placebo with the results of the rates of viral rebound as observed in historical controls.
The proportion of participants in Group 2 who remain off ART maintaining plasma HIV RNA <1000 cps/mL at Week 48 compared to historical controls
Measured: Week 48
To evaluate PGT121, VRC07-523LS and PGDM1400 serum levels at which viral rebound is detected during the analytical treatment interruption.
Serum levels of PGT121, VRC07-523LS and PGDM1400 at time of viral rebound.
Measured: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
HIV genotyping of circulating virus
Genotypic analysis: Development of sequence variations in epitopes known to result in reduced PGDM1400 mAb and/or PGT121 mAb and/or VRC07-523LS mAb neutralization susceptibility
Measured: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
HIV phenotyping of circulating virus
Phenotypic analysis: Changes in viral susceptibility to PGDM1400 mAb and/or PGT121 mAb and/or VRC07-523LS mAb neutralization
Measured: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Apr 2022
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boris Juelg, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals, Harvard School of Public Health (HSPH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor-investigator, Boris Juelg, MD PhD, Beth Israel Deaconess Medical Center
- Investigators
- Boris D Juelg, MD PHD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983030
- Sponsor's protocol ID
- IPCAVD014/HTX1004
- Other IDs
- 5U01AI145801, 38743
- Status last verified
- May 2026
- First submitted
- 5 Jul 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all IPD that underlie the results reported in a respective publication, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Immunogenicity and Efficacy Phase 1/2a Study of a Heterologous Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Regimen Plus Broadly Neutralizing Antibodies PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults on Suppressive ART
- ClinicalTrials.gov ID
- NCT04983030
- Acronym / sponsor ID
- IPCAVD014/HTX1004
- Conditions
- HIV, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndrome, Acquired, Sexually Transmitted Diseases, Viral, Retroviridae Infections
- Keywords
- Monoclonal antibodies, Therapeutic vaccination, Analytical treatment interruption, HIV, AIDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boris Juelg, MD PhDUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals, Harvard School of Public Health (HSPH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | Experimental | Biological: Ad26.Mos4.HIV, Biological: MVA-BN-HIV, Biological: PGT121, Biological: PGDM1400, Biological: VRC07-523LSParticipants 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. |
| Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo | Active comparator | Biological: Ad26.Mos4.HIV, Biological: MVA-BN-HIVParticipants 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. |
| Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs | Active comparator | Biological: PGT121, Biological: PGDM1400, Biological: VRC07-523LSParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (46 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.Mos4.HIVAd26.Mos4.HIV is a tetravalent vaccine containing Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins. | Biological | Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs, Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo |
| MVA-BN-HIVMVA-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 | Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs, Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo |
| PGT121PGT121 is a human mAb that targets the HIV-1 V3 glycan, centered on N332. | Biological | Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs, Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs |
| PGDM1400PGDM1400 is a human mAb that targets the HIV-1 V2 glycan, centered on N160. | Biological | Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs, Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs |
| VRC07-523LSVRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site. | Biological | Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs, Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs |
Primary outcome
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: 7 days post-investigational product administration
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Time frame: 7 days post-investigational product administration
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Percentage of Participants With Unsolicited AEs as a Measure of Safety and Tolerability
Time frame: Approximately up to 72 weeks
An Unsolicited AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From first vaccination until 6 months after last vaccination.
AESIs and potential AESIs are judged to be of special interest because of clinical importance, known or suspected class effects and include thrombotic events and symptomatic thrombocytopenia.
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Time frame: Up to post-vaccination follow-up period until Week 72
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Total IgG and Subclass Specific Antibody Titer
Time frame: Up to post-vaccination follow-up period until Week 72 ]
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Antiviral activity - Percentage of participants who maintain plasma HIV RNA <1000 copies/mL
Time frame: Time between week 24 and week 72 week
Proportion of participants who remain off ART and maintaining plasma HIV RNA <1000 copies/mL for at least two thirds of the time between 24 and 72 weeks of analytical treatment interruption (ATI).
6 secondary outcomes
Measurement of the HIV-1 reservoir (dQVOA)
Time frame: At baseline, Week 24 and Week 32
Measurement of intact proviral DNA
Time frame: At baseline, Week 24 and Week 32
Compare the time to viral rebound (defined as confirmed plasma HIV RNA levels ≥1,000 copies/mL) following Ad26.Mos4.HIV, MVA-BN-HIV and placebo with the results of the rates of viral rebound as observed in historical controls.
Time frame: Week 48
To evaluate PGT121, VRC07-523LS and PGDM1400 serum levels at which viral rebound is detected during the analytical treatment interruption.
Time frame: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
HIV genotyping of circulating virus
Time frame: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
HIV phenotyping of circulating virus
Time frame: From start of ATI until the date of HIV RNA >1000 copies/ml assessed up to week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. We plan to share all IPD that underlie the results reported in a respective publication, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris D Juelg, MD PHD principal investigator
Beth Israel Deaconess Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad26.Mos4.HIV, MVA-BN-HIV and PGT121 in people with HIV and Acquired Immunodeficiency Syndrome, run by Boris Juelg, MD PhD at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: 7 days post-investigational product administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.