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Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly

NCT00347555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-04-12

No results posted yet for this study

Summary

Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host) that enters the human body through the bite of an infected mosquito. The purpose of this study is to find out about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies (proteins made by the body's immune system to help control or prevent infection). Four strengths of the vaccine will be tested. The lowest strength of the vaccine will be tested before the next higher strength is tested. Each dosage (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6 months. Two people in each dosage group will receive injections of a placebo (contains no medication). Participants will include 80 healthy adults between 18 and 40 years of age. Multiple blood draws will occur over the duration of the study. Participants will be involved in study related procedures for approximately 13 months.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

Aluminum Phosphate

1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.

DRUG

Placebo

0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).

BIOLOGICAL

EBA-175 RII-NG Malaria Vaccine

White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00347555 on ClinicalTrials.gov