NCT02663700

Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

Completed Phase 1 Last updated 29 July 2019

What this trial tests

Phase 1 trial testing Artesunate in Plasmodium Falciparum Infection in 112 participants. Completed in 17 December 2018.

Timeline

7 April 2016

Primary endpoint
17 December 2018

17 December 2018

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	prevention
Enrollment	112
Start date	7 April 2016
Primary completion	17 December 2018
Estimated completion	17 December 2018
Sites	1 location across Burkina Faso

Drugs / interventions tested

• Artesunate (ARTESUNATE) — full drug profile →
• PfSPZ Vaccine — full drug profile →
• Placebo

Conditions studied

• Plasmodium Falciparum Infection — all drugs for Plasmodium Falciparum Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 21 to 40, any sex, with Plasmodium Falciparum Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The study duration shall be 34 months and subject participation duration shall be 15-26 months.

Publications & conference data

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

1. Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.
   Jongo SA, Urbano V, Church LWP, Olotu A, et al · · 2021 · cited 55× · PMID 33205741 · DOI 10.4269/ajtmh.20-0435
2. 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
3. A randomized controlled trial showing safety and efficacy of a whole sporozoite vaccine against endemic malaria.
   Sirima SB, Ouédraogo A, Tiono AB, Kaboré JM, et al · · 2022 · cited 32× · PMID 36475905 · DOI 10.1126/scitranslmed.abj3776
4. Immune responses to malaria pre-erythrocytic stages: Implications for vaccine development.
   Abuga KM, Jones-Warner W, Hafalla JCR. · · 2021 · cited 14× · PMID 32981095 · DOI 10.1111/pim.12795
5. Increased levels of anti-PfCSP antibodies in post-pubertal females versus males immunized with PfSPZ Vaccine does not translate into increased protective efficacy.
   Kc N, Church LWP, Riyahi P, Chakravarty S, et al · · 2022 · cited 10× · PMID 36389797 · DOI 10.3389/fimmu.2022.1006716
6. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?
   Potter GE, Callier V, Shrestha B, Joshi S, et al · · 2023 · cited 1× · PMID 38115002 · DOI 10.1186/s12936-023-04802-0
7. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?
   Potter GE, Callier V, Shrestha B, Joshi S, et al · · 2023 · DOI 10.21203/rs.3.rs-3370731/v1