drugset
drugset / Trial / NCT05781542

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

NCT05781542 ↗

Phase 1 Completed 46 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Access to Advanced Health Institute (AAHI) · collabDepartment of Health and Human Services · collabHIV Vaccine Trials Network · collabInovio Pharmaceuticals · collabThe Betty and Dale Bumpers Vaccine Research Center (VRC) · collabThe Wistar Institute · collab
RandomizedSingle-groupOpen-labelPrevention

Summary

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 this recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will elicit VRC01-class B-cell responses as well as antigen-specific T-cell responses.

Timeline

Start
2023-04-10
Primary completion
2024-10-02
Completion
2025-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject IL-12 DNA Vaccine 0.1 mg Intravenous
Subject IL-12 DNA Vaccine 0.4 mg Intravenous
Subject Trimer 4571 Vaccine 100 ug Intramuscular
Subject sD-NP-GT8 DNA Vaccine 0.4 mg Intravenous
Subject sD-NP-GT8 DNA Vaccine 1.6 mg Intravenous
Background 3M-052-AF Small molecule 5 ug Intramuscular
Background Alum Unknown 500 ug Intramuscular

Indications

HIV infectious disease