Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults

Completed · Phase 1

Conditions studied: Malaria

In brief

Background: \- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who receive the vaccine get malaria after being bitten in a controlled setting (a controlled human malaria infection, CHMI). Objective: \- To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting. Eligibility: \- Healthy adults 18 45 years old. Design: * Participants will be screened with medical history, physical exam, blood and lab tests, and EKG. * Participants will be split into 8 groups, to be in the study for 3 12 months. * Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or muscle. * Participants will keep a health diary and be contacted by phone. * For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5 minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be exposed to malaria more than once. * After CHMI, participants will visit the clinic very frequently (including daily visits for 12 days) for 28 days. * Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical history may also be repeated * Participants who develop malaria will be treated immediately at the clinic. Standard treatment takes 72 hours. Malaria symptoms may last up to 3 days.

Key facts

Study ID

NCT02015091

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

141

Starts

2013-12-12

Expected to finish

2016-09-08

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Woman who is breast-feeding or planning to become pregnant during the time interval needed to complete the study.
• Receipt of a malaria vaccine in a prior clinical trial.
• Any history of malaria infection.
• Evidence of increased cardiovascular disease risk; defined as >10% five year risk by the non-laboratory method.
• Current use of systemic immunosuppressant pharmacotherapy.
• History of a splenectomy, sickle cell disease or sickle cell trait.
• Plan for major surgery between enrollment and challenge.
• Known allergy to any component of the vaccine formulation; history of anaphylactic response to mosquito-bites; or known allergy to chloroquine phosphate, atovaquone or proguanil.
• Participation in any study involving another investigational vaccine or drug within 12 weeks prior to enrollment, or plan to participate in another investigational vaccine/drug research during the study.
• Personal beliefs that prohibit the receiving of vaccine product containing human serum albumin within the diluent.
• Use or planned use of any drug with anti-malarial activity that would coincide with study vaccination or challenge.
• History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine.
• Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent or to comply with the protocol schedule.

Where it is running

• University of Maryland Center for Vaccine Dev, Baltimore — Baltimore, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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