Synthetic DNA + Protein Boosts Vaccine for HIV Protection

Recruiting at 7 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with a recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will be safe and immunogenic.

Eligibility Criteria

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

I can attend all clinic visits and be contacted for 12 months after my last vaccine dose.

I am using effective birth control methods.

Negative beta human chorionic gonadotropin (β-HCG) pregnancy test on day of enrollment

Exclusion Criteria

History of angioedema, urticaria, bleeding disorder, seizure disorder, asplenia, active duty and reserve US military personnel, or other significant conditions

I recently received a vaccine that was not a live vaccine.

Breastfeeding or pregnant

Treatment Details

Interventions

• 3M-052-AF (TLR Agonist)
• IL-12 DNA (DNA Vaccine)
• sD-NP-GT8 DNA (DNA Vaccine)
• Trimer 4571 (Protein Vaccine)

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.

Participant Groups

Group I: Group 3 Experimental Treatment 5 Interventions

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

Group II: Group 2 Experimental Treatment 2 Interventions

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

Group III: Group 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Inovio Pharmaceutical Inc.

Collaborator

Trials

1

Recruited

50+

Access to Advanced Health Institute (AAHI)

Collaborator

Trials

1

Recruited

50+

Inovio Pharmaceuticals

Industry Sponsor

Trials

54

Recruited

4,800+

The Betty and Dale Bumpers Vaccine Research Center (VRC)

Collaborator

Trials

1

Recruited

50+

Access to Advanced Health Institute (AAHI)

Collaborator

Trials

30

Recruited

1,700+

HIV Vaccine Trials Network

Collaborator

Trials

42

Recruited

10,800+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

The Wistar Institute

Collaborator

Trials

10

Recruited

790+