Synthetic DNA + Protein Boosts Vaccine for HIV Protection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new HIV vaccine made from synthetic DNA and a protein boost to determine its safety and ability to trigger an immune response. The goal is to assess whether this vaccine can help protect against HIV. Participants will receive different combinations of the vaccine, including IL-12 DNA and sD-NP-GT8 DNA, to compare results. Individuals in good health, without HIV, and at low risk for contracting HIV are suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, certain medications that might impair immune response or recent vaccinations could affect eligibility, so it's best to discuss your specific situation with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of sD-NP-GT8 DNA and IL-12 DNA is safe and generally well tolerated. One study found that using electroporation (a technique that uses electric pulses to help DNA enter cells) with this combination did not raise any major safety concerns. Participants in earlier trials handled the treatment well, with only minor side effects reported.
For the Trimer 4571 and 3M-052-AF combination, studies have also shown it to be safe and well tolerated. In a trial, the Trimer 4571 vaccine was generally safe, though some participants experienced mild to moderate reactions. These reactions were similar to common vaccine side effects, like soreness or a mild fever.
Overall, treatments in this trial have demonstrated promising safety profiles in earlier studies. Based on past research, participants can expect mostly mild and manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for HIV because they use synthetic DNA combined with a protein booster to potentially enhance the body's immune response. Unlike current antiretroviral therapies that primarily control the virus, these investigational treatments aim to provide protection by stimulating the immune system to recognize and fight HIV more effectively. The treatments are administered intradermally, which is a newer delivery method that might improve vaccine uptake. By coformulating IL-12 DNA with the sD-NP-GT8 DNA, the approach seeks to amplify the immune response, offering a novel way to tackle HIV prevention.
What evidence suggests that this trial's treatments could be effective for HIV protection?
Research has shown that specially designed DNA, called NP-GT8 and IL-12, may help the body fight HIV. Early studies found that this DNA combination activates B-cells and T-cells, which are crucial for fighting infections. In this trial, some participants will receive this DNA combination alone, while others will also receive a protein called Trimer 4571. This protein could enhance the immune response, potentially making the vaccine more effective. Studies suggest that these vaccines might help the body control HIV, possibly leading to a "functional cure" where the virus remains undetectable. These promising developments raise hopes for a new HIV vaccine approach.678910
Are You a Good Fit for This Trial?
Adults aged 18-55, in good health with stable blood pressure and no history of severe allergies or chronic conditions that could affect the trial. Must not be pregnant, breastfeeding, or at high risk for HIV. Participants should agree to use birth control and avoid other clinical trials during this study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 administrations of sD-NP-GT8 DNA coformulated with IL-12 DNA, with or without Trimer 4571 boost
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 3M-052-AF
- IL-12 DNA
- sD-NP-GT8 DNA
- Trimer 4571
Trial Overview
The trial is testing synthetic DNAs encoding NP-GT8 and IL-12 with/without TLR-agonist-adjuvanted Env Trimer 4571 boost in HIV-negative adults. It aims to see if these vaccines are safe and can stimulate an immune response.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
a total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. These doses will be administered intradermally via EP of the skin on each upper arm. All participants in Group 3 will also receive 2 administrations of Trimer 4571 at a dose of 100 mcg adjuvanted with 5 mcg of 3M-052-AF + 500 mcg Alum via IM injections into the deltoid muscle at days 85 and 169
a total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm
a total of approximately 9 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 0.4 mg, coformulated with IL-12 DNA at a dose of 0.1 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Inovio Pharmaceutical Inc.
Collaborator
Access to Advanced Health Institute (AAHI)
Collaborator
Inovio Pharmaceuticals
Industry Sponsor
The Betty and Dale Bumpers Vaccine Research Center (VRC)
Collaborator
Access to Advanced Health Institute (AAHI)
Collaborator
HIV Vaccine Trials Network
Collaborator
Department of Health and Human Services
Collaborator
The Wistar Institute
Collaborator
Citations
1.
ctv.veeva.com
ctv.veeva.com/study/clinical-trial-to-evaluate-the-safety-and-immunogenicity-of-synthetic-dnas-encoding-np-gt8-and-il12Clinical Trial to Evaluate the Safety and Immunogenicity of ...
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a ...
Clinical Trial to Evaluate the Safety and Immunogenicity of ...
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted ...
Alum and sD-NP-GT8 DNA and IL-12 DNA in HIV Infections ...
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted ...
Exploring synergies between B- and T-cell vaccine ...
The goal of this workshop was to review data on leading vaccine candidates and to discuss the best strategies for combining these approaches to optimize ...
The Safety and Immunogenicity of an Interleukin-12- ...
Therapeutic immunization might also promote a “functional cure” of HIV infection by inducing indefinite host control of HIV replication to undetectable levels ...
Safety and immunogenicity of an HIV-1 prefusion-stabilized ...
Trimer 4571 was safe, well tolerated, and immunogenic in this first-in-human trial. While this phase 1 trial is limited in size, our results ...
Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine ...
While the vaccine is safe, it is also reactogenic. The overall rate of grade 3 systemic reactogenicity (6 episodes per 35 doses) we observed is similar to ...
Study Details | NCT05828095 | A Clinical Trial to Evaluate ...
A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), ...
Safety and immunogenicity of an HIV-1 prefusion ... - PubMed
Interpretation: Trimer 4571 was safe, well tolerated, and immunogenic in this first-in-human trial. While this phase 1 trial is limited in size, ...
10.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/safety-and-immunogenicity-of-trimer-4571-vaccine-in-hiv-negative-adults/Outcomes of Trimer 4571 Vaccination Support Further ...
Vaccination with Trimer 471 was safe and elicited immunogenic responses in this first human trial performed among HIV-negative adults.
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