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Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.

NCT02859350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-10-15

No results posted yet for this study

Summary

This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10\^6, 1.8x10\^6 or 2.7x10\^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10\^5 PfSPZ) under anti-malarial chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety, tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI).

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

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

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

OTHER

Normal Saline

0.9% Sodium chloride

BIOLOGICAL

PfSPZ Challenge (for PfSPZ-CVac)

live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge)

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Government of Equatorial Guinea

    collaborator OTHER_GOV

  • Marathon Oil Corporation

    collaborator INDUSTRY

  • Noble Oil Services

    collaborator INDUSTRY

  • La Paz Medical Center, Malabo, Equatorial Guinea

    collaborator UNKNOWN

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Salim Abdulla, MD, PHD · Ifakara Health Institute (IHI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-31
Completion
2018-02-28

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 NCT02859350 on ClinicalTrials.gov