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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-11-14

Study results available
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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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

sD-NP-GT8 DNA

0.4 mg

BIOLOGICAL

sD-NP-GT8 DNA

1.6 mg

BIOLOGICAL

IL-12 DNA

0.1 mg

BIOLOGICAL

IL-12 DNA

0.4 mg

BIOLOGICAL

Trimer 4571

100 mcg

BIOLOGICAL

3M-052-AF

5 mcg

DRUG

Alum

500 mcg

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • The Wistar Institute

    collaborator OTHER

  • The Betty and Dale Bumpers Vaccine Research Center (VRC)

    collaborator UNKNOWN

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • Access to Advanced Health Institute (AAHI)

    collaborator OTHER

  • Department of Health and Human Services

    collaborator FED

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-10-02
Completion
2025-04-14
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05781542 on ClinicalTrials.gov