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Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults

NCT03420053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-04-05

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10\^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, metabolically active, non-replicating, radiation-attenuated, cryopreserved Pf sporozoites.

OTHER

Normal Saline Placebo

0.9% sodium chloride solution

BIOLOGICAL

PfSPZ Challenge

Aseptic, purified, live, infectious, cryopreserved Pf sporozoites.

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Medical Care Development, Inc.

    collaborator OTHER

  • 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
2018-02-07
Primary Completion
2018-08-25
Completion
2018-08-25
FDA Drug
Yes

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 NCT03420053 on ClinicalTrials.gov