CH505 HIV Vaccine for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new HIV vaccine to assess its safety and ability to trigger the right immune responses in healthy adults without HIV. Participants will receive different combinations of a protein-based vaccine or an mRNA vaccine (such as CH505 TF mRNA-gp160), along with a special ingredient to boost the immune response. The trial will also examine how the location of booster shots affects immune reactions. Healthy individuals without HIV, who haven't recently received certain vaccines or medications, might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that might impair your immune response, such as certain steroids, you may need to discuss this with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found the CH505 mRNA vaccine to be safe. Most side effects were mild, such as soreness at the injection site or a slight fever, while serious side effects were rare. Similar studies on the DV901-NP and DV902-NP vaccines in healthy adults showed that side effects were usually mild and temporary, with common issues including minor pain at the injection site and mild tiredness. As this study is in its early phase, the main goal is to assess the vaccine's safety. This stage helps researchers determine if the vaccine is safe enough for further testing.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for HIV/AIDS because they use innovative vaccine formulations like CH505 TF mRNA-gp160 and DV901-NP, which show promise in stimulating the immune system differently than current options. Unlike standard antiretroviral therapies that suppress the virus, these vaccines aim to train the body’s immune system to recognize and fight HIV more effectively. The use of mRNA technology in these vaccines is particularly exciting as it represents a cutting-edge approach that has shown success in other areas, like COVID-19 vaccines, potentially offering a new way to prevent or manage HIV infections.
What evidence suggests that this trial's treatments could be effective for HIV/AIDS?
Research has shown that the DV901-NP and DV902-NP vaccines, part of the current trial, produced promising results in animals, suggesting potential in fighting AIDS. Some studies report strong immune responses, crucial for preventing HIV infection. Although protection may decrease over time, these vaccines initially provided significant defense against the virus.
Similarly, the CH505 mRNA-gp160 vaccine, another treatment option in this trial, demonstrated strong immune responses in earlier trials, exceeding the necessary level for potential effectiveness. This vaccine is designed to help the body produce specific defenses against HIV. While more research is needed, these early results are encouraging for future HIV prevention efforts.678910Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 who do not have HIV, hepatitis B or C, and are willing to use effective birth control if needed. Participants must be in good health with normal lab results and blood pressure, and cannot have certain allergies, immune problems, recent vaccines, or serious medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DV901-NP adjuvanted with ACU-026-001-1, followed by either DV902-NP or CH505 mRNA vaccine boosters
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACU-026-001-1
- CH505 TF mRNA-gp160
- CH505 w24 mRNA-gp160
- DV901-NP
- DV902-NP
Trial Overview
The study is testing new CH505 HIV vaccine regimens using protein nanoparticles and mRNA boosters in healthy adults. It aims to see how safe these vaccines are and how well they trigger an immune response against HIV. Some participants will also help test if the injection site affects immunity.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28, with all vaccinations administered in the same deltoid (ipsilateral).
Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28. The Week 0 and Week 4 vaccinations are administered in the same deltoid (ipsilateral), and the Week 28 vaccination is administered in the opposite deltoid (contralateral).
Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by CH505 TF mRNA-gp160 (100 mcg) at Weeks 16 and 24 and CH505 w24 mRNA-gp160 (100 mcg) at Week 32.
Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by DV902-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.
Participants receive DV901-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral intramuscular (IM) injection at Weeks 0 and 8, followed by DV902-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
Study Details | NCT00000745 | A Phase I Multicenter, ...
To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160. Although recent advances have ...
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responses exceeded the predicted threshold needed for 50% vaccine efficacy, and the results from this trial met the go-no-go criteria for ...
4.
bstquarterly.com
bstquarterly.com/article/nih-launches-study-to-evaluate-three-mrna-vaccines-for-hiv/NIH Launches Study to Evaluate Three mRNA Vaccines for ...
The HVTN 302 study will examine whether the following three experimental HIV mRNA vaccines are safe and can induce an immune response: 1) BG505 ...
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While results from the RV144 vaccine efficacy trial were encouraging, protection was modest and not sustained. ly described CH505 transmitted/founder envelope
HIV Immunology Database Search
Patient data: Donor CH505. , were followed in an African patient CH505 for 34 months from the time of infection. for HIV Vaccine Development.
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Project Details
Understanding the mechanisms of an effective neutralizing antibody response to HIV is one of the highest priorities in the field of HIV-specific immunity.
9.
trial.medpath.com
trial.medpath.com/zh/clinical-trial/e859f450ae004ef0/nct03856996-ch505tf-gp120-safety-tolerability-immunogenicity-comparisonA Clinical Trial in Healthy, HIV-1-Uninfected Adult...
The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to ...
MRKAd5 HIV-1 Gag/Pol/Nef Vaccine-Induced T-Cell ... - PMC
Data were available for 46 of the 54 vaccine recipients; eight were excluded due to HIV-1 infection at the time of analysis. Responses were ...
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