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Regimen Optimization Trial of PfSPZ Vaccine in Equatorial Guinea

NCT03590340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-01-07

No results posted yet for this study

Summary

This is a phase 1, randomized regimen optimization study of PfSPZ Vaccine in healthy Equatoguinean volunteers to determine if a condensed, rapid immunization regimen is safe and efficacious. Four different regimens 4 weeks or less in duration will be evaluated for safety, tolerability, immunogenicity, and protective efficacy in comparison to a gold standard 16-week regimen.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)

OTHER

Normal saline

Normal saline is 0.9% sodium chloride

BIOLOGICAL

PfSPZ Challenge (for CHMI)

Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Government of Equatorial Guinea

    collaborator OTHER_GOV

  • Noble Oil Services

    collaborator INDUSTRY

  • Marathon Oil Corporation

    collaborator INDUSTRY

  • Atlantic Methanol Production Company

    collaborator UNKNOWN

  • Equatorial Guinea (EG) liquefied natural gas (LNG)

    collaborator UNKNOWN

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Said Jongo, MD, MMed · Ifakara Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2019-03-12
Completion
2019-03-12
FDA Drug
Yes

Countries

  • Equatorial Guinea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03590340 on ClinicalTrials.gov