NCT03521973 is a Phase 2 clinical trial of PfSPZ Vaccine in Malaria, sponsored by Sanaria Inc..

Who is sponsoring NCT03521973?

NCT03521973 is sponsored by Sanaria Inc..

What drugs are being tested in NCT03521973?

Interventions in NCT03521973: PfSPZ Vaccine, Normal Saline.

Is NCT03521973 still recruiting?

NCT03521973 is currently completed. Last updated 7 October 2021.

Last reviewed 2021-10-07 · How we verify

NCT03521973

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children

Completed Phase 2 Last updated 7 October 2021

What this trial tests

Phase 2 trial testing PfSPZ Vaccine in Malaria in 200 participants. Completed in 3 August 2021.

Timeline

14 June 2018

Primary endpoint
18 May 2021

3 August 2021

Quick facts

Lead sponsor	Sanaria Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	200
Start date	14 June 2018
Primary completion	18 May 2021
Estimated completion	3 August 2021
Sites	1 location across Gabon

Drugs / interventions tested

PfSPZ Vaccine — full drug profile →
Normal Saline

Conditions studied

Malaria — all drugs for Malaria →

Sponsor

Sanaria Inc. — full company profile →

Who can join

Adults 1 to 12, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.

Publications & conference data

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

Safety and efficacy of a three-dose regimen of Plasmodium falciparum sporozoite vaccine in adults during an intense malaria transmission season in Mali: a randomised, controlled phase 1 trial.
Sissoko MS, Healy SA, Katile A, Zaidi I, et al · · 2022 · cited 75× · PMID 34801112 · DOI 10.1016/s1473-3099(21)00332-7
Sporozoite immunization: innovative translational science to support the fight against malaria.
Richie TL, Church LWP, Murshedkar T, Billingsley PF, et al · · 2023 · cited 44× · PMID 37571809 · DOI 10.1080/14760584.2023.2245890
Safety, tolerability, and protective efficacy of a radiation-attenuated, whole sporozoite malaria vaccine in children in Gabon: a randomised, double-blind, placebo-controlled, phase 2 trial.
Agnandji ST, Bok J, Alabi A, Kabwende AL, et al · · 2026 · PMID 40972633 · DOI 10.1016/s1473-3099(25)00434-7

Verify or expand the search:

Other trials of PfSPZ Vaccine

Trials testing the same drug.

NCT05652504 — Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) · Phase 1 · suspended
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
NCT05604521 — A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous C · Phase 1 · terminated
NCT03503058 — Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Agains · Phase 2 · completed
NCT04966871 — Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults · Phase 1 · completed

Other recruiting trials for Malaria

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting

Other Sanaria Inc. trials

Trials by the same sponsor.

NCT06652737 — Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso · Phase 1 · completed
NCT05604521 — A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous C · Phase 1 · terminated
NCT03503058 — Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Agains · Phase 2 · completed
NCT04940130 — PfSPZ Vaccine Trial in Malian Children · Phase 2 · completed
NCT04966871 — Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03521973 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanaria Inc.
Last refreshed: 7 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03521973.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing