Synthetic DNA + Adjuvanted HIV Env Trimer Vaccine for HIV

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new vaccine made from synthetic DNA and immune-boosting substances in people at risk of HIV infection. The vaccine aims to stimulate the immune system to produce antibodies and T-cells that can recognize and fight HIV. DNA vaccination has shown promise in enhancing immune responses.

Eligibility Criteria

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

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

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

Exclusion Criteria

History of immune-mediated disease

Investigator concern for difficulty with venous access

I have a history of irregular heartbeats.

Timeline

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

Treatment Details

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.

Participant Groups

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+