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DNA Vaccine

Synthetic DNA + Protein Boosts Vaccine for HIV Protection

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 8 (2 weeks post 3rd vaccination) and visit 11 (2 weeks post 4th vaccination)

Awards & highlights

No Placebo-Only Group

Summary

This trial examines the safety and effectiveness of a vaccine to protect against HIV. Participants receive DNA and protein boosts to test its effectiveness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at the injection site, mild fever, fatigue, muscle aches, and possibly allergic reactions to components of the vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at visit 8 (2 weeks post 3rd vaccination) and visit 11 (2 weeks post 4th vaccination)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at visit 8 (2 weeks post 3rd vaccination) and visit 11 (2 weeks post 4th vaccination)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 8 (2 weeks post 3rd vaccination) and visit 11 (2 weeks post 4th vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnitude of CD4+ and CD8+ T-cell responses

Response rate of CD4+ and CD8+ T-cell responses

Response rate of HIV-1-specific binding Ab responses to Trimer 4571

+5 more

Secondary study objectives

Magnitude of eOD-GT8-60mer

Magnitude of monomer Ab

Magnitude of nAb and breadth against tier-2 HIV-1 isolates

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment5 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 2Experimental Treatment2 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 1Experimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alum

2013

Completed Phase 2

~420

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