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NCT03831503

A Study of INO-A002 in Healthy Dengue Virus-naive Adults

Completed Phase 1 Last updated 14 December 2023
What this trial tests

Phase 1 trial testing INO-A002 in Healthy Volunteers in 30 participants. Completed in 3 October 2022.

Timeline
7 February 2019
Primary endpoint
3 October 2022
3 October 2022

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment30
Start date7 February 2019
Primary completion3 October 2022
Estimated completion3 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 60, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase 1, open label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers ages 18-60 years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. DNA vaccines: prime time is now.
    Gary EN, Weiner DB. · · 2020 · cited 138× · PMID 32259744 · DOI 10.1016/j.coi.2020.01.006
  2. In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies.
    Patel A, Bah MA, Weiner DB. · · 2020 · cited 55× · PMID 32157600 · DOI 10.1007/s40259-020-00412-3
  3. In vivo delivery of synthetic DNA-encoded antibodies induces broad HIV-1-neutralizing activity.
    Wise MC, Xu Z, Tello-Ruiz E, Beck C, et al · · 2020 · cited 37× · PMID 31697648 · DOI 10.1172/jci132779
  4. Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases.
    Xu Z, Patel A, Tursi NJ, Zhu X, et al · · 2020 · cited 32× · PMID 35047878 · DOI 10.3389/fmedt.2020.571030
  5. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
    Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7
  6. Emerging antibody-based products for infectious diseases: Planning for metric ton manufacturing.
    Whaley KJ, Zeitlin L. · · 2022 · cited 21× · PMID 34259613 · DOI 10.1080/21645515.2021.1930847
  7. Novel Delivery Systems for Checkpoint Inhibitors.
    Lamichhane P, Deshmukh R, Brown JA, Jakubski S, et al · · 2019 · cited 21× · PMID 31373327 · DOI 10.3390/medicines6030074
  8. DNA-Based Delivery of Checkpoint Inhibitors in Muscle and Tumor Enables Long-Term Responses with Distinct Exposure.
    Jacobs L, De Smidt E, Geukens N, Declerck P, et al · · 2020 · cited 17× · PMID 32101701 · DOI 10.1016/j.ymthe.2020.02.007

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other University of Pennsylvania trials

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Data sources for this page

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