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Cancer Vaccine

HIV Trimer mRNA Vaccines for HIV Prevention

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Greater than or equal to 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
Must not have
Immunodeficiency
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 52 weeks, 6 months after the 3rd vaccination timepoint
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of different HIV vaccines.

Who is the study for?
Healthy adults aged 18-55 who are HIV-negative, not pregnant or breastfeeding, and at low risk for HIV infection. They must be willing to use birth control if applicable, have normal blood counts and organ function tests, understand the study requirements, and commit to follow-up visits. Exclusions include poorly controlled hypertension, diabetes (except diet-controlled type 2), previous investigational HIV vaccine recipients (unless placebo), acute illness on vaccination day, recent immunosuppressants or blood products usage.
What is being tested?
The trial is testing three different mRNA vaccines based on the BG505 MD39 HIV trimer: BG505 MD39.3 alone; with gp151; and with gp151 CD4KO. It's an early-phase study assessing safety and whether these vaccines can stimulate the body's immune system to produce antibodies against HIV in people without the virus.
What are the potential side effects?
Potential side effects may include typical reactions seen with other vaccines such as pain at injection site, fatigue, headache, muscle aches or fever. Since this is a phase 1 trial primarily focused on safety and tolerability of new vaccine candidates for HIV prevention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hemoglobin level is at least 12.0 g/dL, and I am a transgender female on hormone therapy for over 6 months.
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I have tested negative for HIV.
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I am ready and able to understand and consent to participate in this study.
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My hemoglobin level is at least 13.0 g/dL, and I was assigned male at birth or am a transgender male on hormone therapy for over 6 months.
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I am between 18 and 55 years old.
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My hemoglobin level is at least 11.0 g/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a weakened immune system.
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I have a diagnosed bleeding disorder that needs special care.
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I do not have a functioning spleen.
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I do not have asthma.
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I needed steroids for flare-ups twice or more last year.
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I use my asthma rescue inhaler more than twice a week.
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I use a medium-to-high dose of inhaled corticosteroids daily.
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My blood pressure is consistently below 140/90 mm Hg.
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I have not received any live vaccines recently.
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I have received an mRNA COVID-19 vaccine.
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I have received a vaccine that is not live.
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I have had myocarditis or pericarditis.
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I have a diagnosed form of angioedema.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 52 weeks, 6 months after the 3rd vaccination timepoint
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 52 weeks, 6 months after the 3rd vaccination timepoint for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chemistry and Hematology Laboratory Measures - ALT in U/L
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
+13 more
Secondary study objectives
Magnitude of CD4+ T-cell Responses
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNAExperimental Treatment1 Intervention
18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Group II: Part B, Group 2: BG505 MD39.3 gp151 mRNAExperimental Treatment1 Intervention
18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Group III: Part B, Group 1: BG505 MD39.3 mRNAExperimental Treatment1 Intervention
18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6
Group IV: Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNAExperimental Treatment1 Intervention
18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Group V: Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNAExperimental Treatment1 Intervention
18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Group VI: Part A, Group 1: Low dose BG505 MD39.3 mRNAExperimental Treatment1 Intervention
18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Department of Health and Human ServicesFED
231 Previous Clinical Trials
935,441 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,503 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,320 Previous Clinical Trials
5,364,537 Total Patients Enrolled

Media Library

BG505 MD39.3 gp151 CD4KO mRNA (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05217641 — Phase 1
Human Immunodeficiency Virus Infection Research Study Groups: Part B, Group 2: BG505 MD39.3 gp151 mRNA, Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA, Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA, Part A, Group 1: Low dose BG505 MD39.3 mRNA, Part B, Group 1: BG505 MD39.3 mRNA, Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA
Human Immunodeficiency Virus Infection Clinical Trial 2023: BG505 MD39.3 gp151 CD4KO mRNA Highlights & Side Effects. Trial Name: NCT05217641 — Phase 1
BG505 MD39.3 gp151 CD4KO mRNA (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217641 — Phase 1
~29 spots leftby Nov 2025
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