46 Participants Needed

Synthetic DNA + Protein Boosts Vaccine for HIV Protection

Recruiting at 7 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: HIV PrEP
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, certain medications that might impair immune response or recent vaccinations could affect eligibility, so it's best to discuss your specific situation with the trial team.

What data supports the effectiveness of the treatment 3M-052-AF, IL-12 DNA, sD-NP-GT8 DNA, Trimer 4571 for HIV protection?

Research shows that DNA vaccines, like those used in the treatment, can trigger strong immune responses in animals and humans, which are important for fighting HIV. Studies have found that adding components like IL-12 can enhance these immune responses, suggesting potential effectiveness in HIV protection.12345

Is the synthetic DNA and protein vaccine for HIV generally safe in humans?

The research indicates that DNA vaccines, including those with synthetic components, have been tested in humans and animals, showing immune responses without major safety concerns. However, specific safety data for the exact combination of synthetic DNA and protein in humans is not detailed in the available studies.23567

How does the treatment IL-12 DNA, sD-NP-GT8 DNA differ from other HIV treatments?

This treatment is unique because it uses synthetic DNA with optimized codon usage to enhance the immune response, which is further boosted by a protein component. This approach aims to induce stronger and broader antibody responses compared to traditional methods, potentially offering better protection against HIV.5891011

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
See 13 more

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
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 administrations of sD-NP-GT8 DNA coformulated with IL-12 DNA, with or without Trimer 4571 boost

24 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • 3M-052-AF
  • IL-12 DNA
  • sD-NP-GT8 DNA
  • Trimer 4571
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
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

Find a Clinic Near You

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+

References

Approaches for the design and evaluation of HIV-1 DNA vaccines. [2019]
Therapeutic immunization of HIV-infected chimpanzees using HIV-1 plasmid antigens and interleukin-12 expressing plasmids. [2019]
Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. [2018]
Protection from pathogenic SIV challenge using multigenic DNA vaccines. [2019]
Increased immune response elicited by DNA vaccination with a synthetic gp120 sequence with optimized codon usage. [2020]
[The immune response in mice inoculated with HIV-1 gag-gp120 chimeric gene DNA vaccine and IL-18 plasmid]. [2020]
In vivo engineering of a cellular immune response by coadministration of IL-12 expression vector with a DNA immunogen. [2006]
HIV-1 Env DNA vaccine plus protein boost delivered by EP expands B- and T-cell responses and neutralizing phenotype in vivo. [2021]
Gene gun DNA vaccination with Rev-independent synthetic HIV-1 gp160 envelope gene using mammalian codons. [2019]
Immunogenicity of a novel DNA vaccine cassette expressing multiple human immunodeficiency virus (HIV-1) accessory genes. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
An Enhanced Synthetic Multiclade DNA Prime Induces Improved Cross-Clade-Reactive Functional Antibodies when Combined with an Adjuvanted Protein Boost in Nonhuman Primates. [2019]