Synthetic DNA + Adjuvanted HIV Env Trimer Vaccine for HIV

No longer recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: PrEP

Must not be taking: Glucocorticoids, Blood products

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, Seizure disorder, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new HIV vaccine to determine its safety and ability to produce an immune response against HIV. The vaccine uses synthetic DNA, which acts as a blueprint to help the body recognize and fight the virus. Participants will receive either the synthetic DNA vaccine (INO-6160) alone or with another component, Trimer-4571, to identify the most effective option. Individuals at low risk for HIV and in good general health may be suitable candidates for this trial. 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 for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications that impair immune response or recent vaccinations may 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 INO-6160, a synthetic DNA vaccine, was safe and well-tolerated in earlier trials. A study of a similar vaccine, PENNVAX-GP, found it was not only safe but also triggered strong immune responses, suggesting that INO-6160 might also be safe.

Trimer-4571, another part of the trial, has been tested in people before. Studies indicated it was safe and well-tolerated, with no serious side effects. Participants developed antibodies, proteins that help fight infections, after receiving the vaccine. This is a positive sign for its safety and effectiveness.

In summary, both INO-6160 and Trimer-4571 have shown promising safety results in past studies. They were generally well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these HIV treatments because they are exploring new ways to boost the immune response against the virus. Unlike traditional antiretroviral therapies that focus on suppressing the virus, INO-6160 involves synthetic DNA designed to enhance the body's immune defense by inducing a strong cellular immune response. Trimer-4571, on the other hand, uses an adjuvanted HIV Env trimer vaccine that could potentially improve antibody responses, providing an additional layer of protection. These innovative approaches aim to not just control but possibly prevent HIV, marking a significant shift from current treatment strategies.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that INO-6160, a synthetic DNA vaccine, previously triggered strong immune responses in clinical trials. Inovio, the company that developed it, reported nearly 100% success in activating the immune system, which is promising for fighting HIV. This vaccine teaches the body to recognize and combat the virus using its genetic information. In this trial, some participants will receive INO-6160 alone.

Trimer-4571, when combined with immune-boosting substances, has also shown safety and effectiveness in generating immune responses. Early trials in adults without HIV found it safe and capable of activating the body's defenses. In this trial, other participants will receive a combination of INO-6160 and Trimer-4571 with additional immune-boosting substances. These treatments are being studied for their potential to offer strong protection against HIV. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-55, at low risk for HIV, in good health with normal blood counts and organ function. Must not be pregnant or planning pregnancy, agree to use birth control, and avoid high-risk HIV behaviors. Excludes those with certain allergies, bleeding disorders, severe asthma, recent non-HIV vaccines or immunotherapies.

Inclusion Criteria

Agrees not to enroll in another study of an investigational agent during participation in the trial

I am willing and able to understand and sign the consent form.

Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator

Exclusion Criteria

History of immune-mediated disease

Investigator concern for difficulty with venous access

I have a history of irregular heartbeats.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INO-6160, alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum

12 months

Multiple visits for vaccinations and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• INO-6160
• Trimer-4571

Trial Overview The trial tests INO-6160 (synthetic DNAs for an HIV protein & immune booster) alone or followed by VRC HIV Env Trimer 4571 with adjuvants. It aims to see if these can elicit antibody and T-cell responses against HIV in a randomized open-label setup.

How Is the Trial Designed?

Group I: Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) Experimental Treatment 2 Interventions

The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm. The dose of Trimer 4571, 100 mcg, will be administered as 2 injections delivered intramuscularly (IM), one in each arm.

Group II: Group #1: INO-6160/ 2.0 mg Experimental Treatment 1 Intervention

The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05828095

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), Alone or in a ...

2. ir.inovio.com ir.inovio.com/news-releases/news-releases-details/2018/Inovio-HIV-Vaccine-Which-Generated-Near-100-Immune-Responses-Sustained-Durable-Memory-Responses-Measured-One-Year-After-The-Start-of-Clinical-Trial/default.aspx

Inovio HIV Vaccine, Which Generated Near 100% Immune ... Inovio previously reported that PENNVAX-GP elicited the highest overall levels of immune response rates (cellular and humoral) ever demonstrated ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/ino-6160-inovio-pharmaceuticals-human-immunodeficiency-virus-hiv-infections-aids-likelihood-of-approval/

INO-6160 by Inovio Pharmaceuticals for Human ... According to GlobalData, Phase I drugs for Human Immunodeficiency Virus (HIV) Infections (AIDS) have a 70% phase transition success rate (PTSR) ...

4. treatmentactiongroup.org treatmentactiongroup.org/wp-content/uploads/2024/07/pipeline_HIV_VAX_2024_final.pdf

HIV Vaccines and Passive Immunization Pipeline Report ... Researchers at Oxford University announced results in July 2023 showing successful induction of T cell responses with their chimpanzee adenovirus (ChAd) and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881492/

Exploring synergies between B- and T-cell vaccine ... There are many challenges to the design and development of a broadly effective HIV vaccine. ... ・HIV Env Trimer/IL-12 (INO-6160) (DNA). ・4571 ...

6. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/037bd794-8815-4220-886c-c2b2c8254a5b-MECA.pdf?abstractid=5533175&mirid=1

DNA electroporation of HIV Env elicits unique pattern of ... the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env ... PENNVAX-GP((R)) DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable ...

7. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-type-1-hiv-1-infection-2-2023-46de4

Synthetic DNA + Adjuvanted HIV Env Trimer Vaccine for HIV Adults aged 18-55, at low risk for HIV, in good health with normal blood counts and organ function. Must not be pregnant or planning pregnancy, agree to use ...