Your session is about to expire
← Back to Search
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 26 weeks, 2 weeks after the 3rd vaccination timepoint
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My hemoglobin level is at least 12.0 g/dL, and I am a transgender female on hormone therapy for over 6 months.
Select...
I have tested negative for HIV.
Select...
I am ready and able to understand and consent to participate in this study.
Select...
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.
Select...
I am between 18 and 55 years old.
Select...
My hemoglobin level is at least 11.0 g/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 10 and 26 weeks, 2 weeks after the 2nd and 3rd vaccination timepoints, respectively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 10 and 26 weeks, 2 weeks after the 2nd and 3rd vaccination timepoints, respectively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events (AEs)
Adverse events leading to early participant withdrawal or permanent discontinuation
Adverse events of special interest (AESIs)
+5 moreSecondary outcome measures
Magnitude of CD4+ T-cell responses
Magnitude of serum IgG binding antibodies to the BG505 trimer, and specific epitopes (base of trimer, V3, internal epitope)
Magnitude of serum antibody neutralization of a vaccine-matched tier 2 HIV-1 strain
+8 moreTrial 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
226 Previous Clinical Trials
928,841 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,471 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,024 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed my COVID-19 vaccination series at least 4 weeks ago, or have approval for an exception.I have a weakened immune system.I agree to use birth control from 3 weeks before joining until 3 months after my third vaccine dose.My hemoglobin level is at least 12.0 g/dL, and I am a transgender female on hormone therapy for over 6 months.I have a diagnosed bleeding disorder that needs special care.I haven't received blood products or immunoglobulin in the last 4 months.I do not have a functioning spleen.I have type 1 or type 2 diabetes.I do not have a fever or serious illness today.I have a seizure disorder, but childhood febrile seizures or seizures from alcohol withdrawal over 5 years ago don't apply.I am ready and able to understand and consent to participate in this study.I take more than one daily medication for ongoing treatment and have been on a stable dose for over two years.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.I started allergy immunotherapy within the last year, pending approval.I haven't taken strong immune-suppressing drugs in the last 168 days, except for allowed minor treatments.I have had an immune system-related disease, but it's either mild or happened over 2 years ago.I haven't taken any experimental drugs with a short effect in the last month, or if I have, those with longer effects were over a year ago or approved for this trial.I have tested negative for HIV.I can become pregnant and agree to use birth control as required, and have a negative pregnancy test.I have received specific treatments.I do not have asthma.I needed steroids for flare-ups twice or more last year.I use my asthma rescue inhaler more than twice a week.I use a medium-to-high dose of inhaled corticosteroids daily.I am between 18 and 55 years old.My blood pressure is consistently below 140/90 mm Hg.I agree to follow the study's procedures and attend all clinic visits.I have not received any live vaccines recently.I have received an mRNA COVID-19 vaccine.I have received a vaccine that is not live.I have had myocarditis or pericarditis.I have a diagnosed form of angioedema.I needed urgent care or was hospitalized for asthma in the last year.My hemoglobin level is at least 11.0 g/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA
- Group 2: Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA
- Group 3: Part B, Group 2: BG505 MD39.3 gp151 mRNA
- Group 4: Part A, Group 1: Low dose BG505 MD39.3 mRNA
- Group 5: Part B, Group 1: BG505 MD39.3 mRNA
- Group 6: Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA
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.
Are there any vacancies for potential participants in this clinical investigation?
"It appears that, as of the last edit on September 29th 2022, this trial is no longer actively recruiting. However, there are still 1181 other clinical trials happening now which are searching for candidates to join their study."
Answered by AI
Does this research accept senior citizens as participants?
"The eligibility criteria for this clinical trial indicate that participants must be under the age of 55 and above 18 years old."
Answered by AI
At what locations can patients access this clinical trial?
"Columbia P&S CRS [30329] in New york, Bidmc Vcrs [32077] in Boston, and Brigham and Women's Hospital Vaccine CRS [30007] are 3 of the 15 locations where this trial is running. An additional 10 sites can also be found across the nation."
Answered by AI
Has the BG505 MD39.3 gp151 CD4KO mRNA received authorization from the FDA?
"Our team at Power gauged the safety of BG505 MD39.3 gp151 CD4KO mRNA as a 1 due to its Phase 1 trial status, which implies only scant evidence that it's safe and effective."
Answered by AI
Who would be considered a viable candidate for this experiment?
"This trial is taking applications from 108 HIV positive individuals aged 18-55. Admittance for each applicant is contingent on them meeting the following conditions: being willing and able to complete a consent form, not participating in another clinical trial, general good health according to the site investigator's judgement, physical exams with no findings that could interfere with safety or reactogenicity assessment as judged by the site investigator; assessed as low risk of HIV acquisition per guidelines, discuss potential risks associated with HIV infection, agree to risk reduction counselling, avoid behaviour associated with high risk of HIV exposure through final study visit (including those prescribed pre-exposure prophyl"
Answered by AI
What are the primary aims of this investigation?
"This experiment has two primary goals. Firstly, it aims to document any adverse reactions causing early participant withdrawal or termination of the trial. Secondly, its objectives are focused on CD4+ T-Cell responses (assessed by intracellular cytokine staining), IgG binding antibody production against the BG505 trimer and specific epitopes (as measured with BAMA tests), as well as serum neutralization of a vaccine-matched tier 2 HIV strain (measured through a TZM-bl assay). The entire process will take no less than seven days per injection."
Answered by AI
Who else is applying?
What site did they apply to?
UCLA Vine Street Clinic CRS [31607]
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger