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Virus Therapy

HIV Vaccine for HIV/AIDS

Phase 1 & 2

Waitlist Available

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

Must not have

Contraindication to intramuscular injections, placement of intravenous lines, and blood draws

History of HIV-associated malignancy, lymphoma, or virus-associated cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first vaccination until 6 months after last vaccination.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have shots, IV lines, or blood taken due to medical reasons.

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I have had cancer linked to HIV, lymphoma, or a virus.

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I have had HIV-related brain issues or a rare brain infection.

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I have or recently had cancer that needed chemo or surgery, not related to HIV.

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I have a history of serious heart conditions.

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I am currently on HIV medication that is not an NRTI or integrase inhibitor.

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I haven't had major surgery in the last 3 months and don't plan any soon.

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I can communicate clearly with my doctor.

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My liver disease is in an advanced stage.

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I currently have an untreated gonorrhea or chlamydia infection.

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I have had sudden onset of nerve damage.

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I have had a thyroidectomy or been on medication for thyroid disease in the past year.

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I have a history of heart disease as per the 2013 guidelines.

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I have had blood clotting issues with low platelet counts.

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I haven't had a fever or acute illness in the last 24 hours.

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I have an ongoing hepatitis B, hepatitis C, or syphilis infection.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first vaccination until 6 months after last vaccination. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

PGDM1400

2019

Completed Phase 1

~30

Ad26.Mos4.HIV

2016

Completed Phase 3

~4290