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Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso

NCT01018459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.

Conditions

Interventions

BIOLOGICAL

Ad35.CS.01 Circumsporozoite Malaria Vaccine

Ad35.CS.01 appears clear to slightly opalescent with no visible particles. Each 0.75 mL dose of the assigned dosage will be administered via intramuscular injection into the deltoid muscle. Dosages: 10\^9 viral particles (vp)/mL, 10\^10 vp/mL, 5 x 10\^10 vp/mL, and 10\^11 vp/mL.

DRUG

Placebo

Normal saline placebo control delivered via intramuscular injection into the deltoid muscle.

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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Burkina Faso

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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 NCT01018459 on ClinicalTrials.gov