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Virus Therapy
HIV Vaccine for HIV/AIDS
Phase 1 & 2
Recruiting
Led By Boris D Juelg, MD PHD
Research Sponsored by Boris Juelg, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be on suppressive ART for at least 48 weeks prior to screening
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first vaccination until 6 months after last vaccination.
Awards & highlights
Study Summary
This trial is studying a possible HIV vaccine.
Who is the study for?
Adults aged 18-70 with HIV, on stable ART for at least 48 weeks, and undetectable viral load. They must understand the study, consent to it, be willing to restart ART if needed, and adhere to protocol restrictions. Excluded are those with acute illness or certain medical conditions like advanced liver disease or history of significant heart issues.Check my eligibility
What is being tested?
The trial is testing a vaccine regimen (Ad26.Mos4.HIV prime and MVA-BN-HIV boost) combined with antibodies (PGT121, PGDM1400, VRC07-523LS) in HIV-infected adults on ART. It's a Phase 1/2a study assessing safety, tolerability, immune response and preliminary effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at injection site, fever or fatigue. Since this involves an experimental treatment for HIV patients already on medication therapy (ART), there might also be unique immune responses that will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on ART for at least 48 weeks.
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My HIV viral load is under control and has been stable since my last treatment change.
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I am between 18 and 70 years old.
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My health is stable as confirmed by recent medical exams and tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first vaccination until 6 months after last vaccination.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first vaccination until 6 months after last vaccination.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antiviral activity - Percentage of participants who maintain plasma HIV RNA <1000 copies/mL
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
+4 moreSecondary outcome measures
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.
HIV genotyping of circulating virus
HIV phenotyping of circulating virus
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbsExperimental Treatment5 Interventions
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.
Group II: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PlaceboActive Control2 Interventions
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.
Group III: Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbsActive Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.Mos4.HIV
2016
Completed Phase 3
~4130
PGT121
2019
Completed Phase 1
~30
PGDM1400
2019
Completed Phase 1
~30
VRC07-523LS
2019
Completed Phase 1
~310
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,961 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,035 Total Patients Enrolled
Harvard School of Public Health (HSPH)OTHER
272 Previous Clinical Trials
16,304,989 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a severe HIV-related illness in the last 10 years.I have been on ART for at least 48 weeks.I cannot have shots, IV lines, or blood taken due to medical reasons.I have had cancer linked to HIV, lymphoma, or a virus.My immune system does not work properly.I have received all required vaccines within the specified timeframes.I have had HIV-related brain issues or a rare brain infection.I weigh over 115kg, have drug resistance, or may not follow study rules.I have or recently had cancer that needed chemo or surgery, not related to HIV.I have a history of serious heart conditions.I am currently on HIV medication that is not an NRTI or integrase inhibitor.I haven't had major surgery in the last 3 months and don't plan any soon.I can communicate clearly with my doctor.My liver disease is in an advanced stage.My HIV viral load is under control and has been stable since my last treatment change.I have no uncontrolled chronic or significant acute health issues.I am between 18 and 70 years old.I currently have an untreated gonorrhea or chlamydia infection.I have not received immunoglobulins or blood products recently.I have had sudden onset of nerve damage.I have had a thyroidectomy or been on medication for thyroid disease in the past year.I am willing and able to restart my ART treatment as per the study's guidelines.I have a history of heart disease as per the 2013 guidelines.I have had blood clotting issues with low platelet counts.I haven't had a fever or acute illness in the last 24 hours.I have an ongoing hepatitis B, hepatitis C, or syphilis infection.My health is stable as confirmed by recent medical exams and tests.
Research Study Groups:
This trial has the following groups:- Group 1: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus PGT121, PGDM1400, and VRC07-523LS bNAbs
- Group 2: Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Plus Placebo
- Group 3: Placebo Plus PGT121, PGDM1400, and VRC07-523LS bNAbs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could prospective participants submit their candidacy for this research endeavor?
"Indeed, perusal of clinicaltrials.gov reveals that this study is currently searching for enrollees. The initial post was on April 1st 2022 and the latest update occured 18 days later. This investigation requires 36 individuals from a single trial site to participate."
Answered by AI
Are there any documented precedents of MVA-BN-HIV being evaluated in a scientific investigation?
"Presently, there are 16 clinical trials for MVA-BN-HIV in progress. None of these are in Phase 3 yet. The primary research site is located in Boston, Massachusetts; however, the study has expanded to 75 testing locations across the US."
Answered by AI
How many participants are enrolled in the investigation?
"Affirmative, the information stored on clinicaltrials.gov verifies that this medical trial is actively recruiting patients. It was initially made publicly available on April 1st 2022 and has been recently updated as of April 18th 2022. A total of 36 people are expected to join from a single site."
Answered by AI
What are the primary aims of this medical experiment?
"This clinical trial will be monitored for a 6 month period, measuring the safety and tolerability of participants using Percentage of Participants With Solicited Systemic AEs (adverse events) as their primary outcome. Secondary objectives include Measurement of intact proviral DNA via IPDA, quantification of PGT121, VRC07-523LS and PGDM1400 serum levels to detect viral rebound during an analytical treatment interruption, and HIV genotyping to measure sequence variations that might affect neutralization susceptibility."
Answered by AI
Is the age range of participants in this study limited to adults over 35?
"This trial seeks to include patients aged between 18 and 70. There are 614 studies available for minors, while seniors may find assistance in the 1575 trials catered towards them."
Answered by AI
Does my profile meet the criteria for participating in this trial?
"Candidates between the ages of 18 and 70 who suffer from AIDS may qualify for this clinical trial. 36 total patients will be admitted into the experiment."
Answered by AI
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