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Safety and Immunogenicity in Age De-Escalation of PfSPZ Vaccine in Tanzanian Adults, Children, and Infants

NCT02613520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-10-15

No results posted yet for this study

Summary

The present trial will evaluate safety and tolerability as well as the vaccine-induced humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children, and infants who receive doses of 1.8x10\^6, 9.0x10\^5, 4.5x10\^5 or 2.7x10\^5 PfSPZ of PfSPZ Vaccine by direct venous inoculation (DVI),compared with control groups receiving normal saline (NS) placebo by DVI. In addition, as an exploratory objective, controlled human malaria infection (CHMI) will be used to assess efficacy in adults three weeks following immunization.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

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

OTHER

Normal Saline

0.9% Sodium chloride

BIOLOGICAL

PfSPZ Challenge (for CHMI)

live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge) Controlled human malaria infection (CHMI) by direct venous inoculation of 3,200 PfSPZ Challenge

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Medical Care Development, Inc.

    collaborator OTHER

  • Tanzania Commission for Science and Technology

    collaborator OTHER

  • Government of Equatorial Guinea

    collaborator OTHER_GOV

  • Marathon Oil Corporation

    collaborator INDUSTRY

  • Noble Oil Services

    collaborator INDUSTRY

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Said Jongo, MD, MMED · Ifakara Health Institute (IHI), Bagamoyo, Tanzania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-02-28
Completion
2017-03-31

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 NCT02613520 on ClinicalTrials.gov