deltatrials
Completed PHASE1 INTERVENTIONAL 11-arm NCT02942277

Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali

Phase 1 Dose Escalating, Double-Blind, Randomized Comparator Controlled Trial of the Safety andImmunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum at Full and Fractional Dosing in Adults in Mali

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions Malaria
Interventions AS01 Coartem Engerix-B Menactra Normal Saline Pfs230D1M-EPA Pfs25M-EPA
Updated 20 times since 2017 Last updated: Nov 18, 2024 Started: Oct 21, 2016 Primary completion: Jul 15, 2020 Completion: Jul 15, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Malaria and is currently completed. National Institute of Allergy and Infectious Diseases (NIAID) leads this study, which shows 20 recorded versions since 2016 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~May 2018 · 7 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~Aug 2019 · 7 months · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Aug 2020 · 5 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshot~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – present · 18 months · monthly snapshot

Change History

20 versions recorded

  1. Jan 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Jan 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Feb 2022 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jan 2021 — Feb 2022 [monthly]

    Completed PHASE1

▶ Show 15 earlier versions

  1. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE1

  2. Aug 2020 — Sep 2020 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  3. Mar 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1

  4. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1

  5. Oct 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

  6. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: Enrolling By Invitation → Active Not Recruiting

  7. Jan 2019 — Aug 2019 [monthly]

    Enrolling By Invitation PHASE1

  8. Sep 2018 — Jan 2019 [monthly]

    Enrolling By Invitation PHASE1

    Status: Active Not Recruiting → Enrolling By Invitation

  9. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE1

  10. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE1

  11. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  12. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  13. Oct 2017 — May 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  14. Feb 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

  15. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institutes of Health Clinical Center (CC)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations