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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 12 months following any receipt of study products

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ 12 months following any receipt of study products

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following any receipt of study products

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following any receipt of study products for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of VRC01-class B cells from lymph nodes

Frequency of VRC01-class B cells from periphery

Magnitude of CD4+ and CD8+ T-cell responses

+13 more

Secondary outcome measures

Magnitude of eOD-GT8-60mer

Magnitude of monomer Ab

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

+4 more

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inovio Pharmaceutical Inc.UNKNOWN

Access to Advanced Health Institute (AAHI)UNKNOWN

28 Previous Clinical Trials

1,620 Total Patients Enrolled

Inovio PharmaceuticalsIndustry Sponsor

53 Previous Clinical Trials

4,793 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the degree of safety associated with Group 1 patients?

"Group 1's safety is rated with a score of 1 as this Phase 1 trial has only gathered scant evidence for its efficacy and security."

Answered by AI

Does this investigation accept participants younger than sixty years old?

"This clinical trial's restrictions dictate that patients must be between 18 and 55 years of age to qualify."

Answered by AI

Who has the right to participate in this clinical experiment?

"To take part in this trial, candidates must have human immunodeficiency virus infection and be between 18 to 55 years old. This investigation is looking for a total of 45 participants."

Answered by AI

How far-reaching is the current trial in terms of geographical locations?

"This clinical trial is running in various locations, such as San Francisco Vaccine and Prevention CRS located in California, Brigham and Women's Hospital Vaccine CRS [30007] in Boston Massachusetts, and Soweto HVTN CRS situated in Gauteng."

Answered by AI

Are there vacancies available for those interested in participating within the experiment?

"According to clinicaltrials.gov the current recruitment phase of this trial has been closed since March 10th, 2023 when it was last updated. Despite its conclusion, there are still 468 other medical studies that require patient participation at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV

2023. "Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05781542.