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Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

NCT02132299 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2016-04-27

No results posted yet for this study

Summary

This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).

Conditions

  • Malaria
  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites (PfSPZ)

BIOLOGICAL

Normal Saline (Placebo)

BIOLOGICAL

PfSPZ Challenge

Live, infectious, aseptic, purified, vialed, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) for CHMI

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Tanzania Commission for Science and Technology

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Salim Abdulla, MD, PhD · Ifakara Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • Tanzania

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 NCT02132299 on ClinicalTrials.gov