NCT00371189

Brief Summary

Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine licensed to prevent malaria. The purpose of this study is to find the most effective and safest dose of an experimental vaccine for the treatment of malaria. Participants will include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center and Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or placebo (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators will evaluate how the body responds to increasing dosage strengths of the vaccine. Study procedures include physical exam, multiple blood draws, and completion of a memory aid (diary). Each participant will be actively involved in the study for about 12 months. Then, an annual phone call will be made to check for any serious illness events for a period of 5 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 22, 2014

Status Verified

June 1, 2014

Enrollment Period

7.4 years

First QC Date

August 31, 2006

Last Update Submit

September 18, 2014

Conditions

Plasmodium Falciparum Infection

Keywords

circumsporozoite, malaria, vaccine

Outcome Measures

Primary Outcomes (1)

  • Frequency and severity of local, systemic, and safety laboratory adverse events.

    Enrollment through to Day 208

Secondary Outcomes (3)

  • T cell responses against the malaria circumsporozoite antigen by enzyme-linked immunosorbent spot (ELISPOT) and flow cytometry.

    Days 28, 56, 120, 180, 208.

  • Antibody titers against the malaria circumsporozoite antigen via enzyme-linked immunosorbent assay (ELISA).

    Days 28, 56, 120, 180, 208.

  • Neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay.

    Days 28, 56, 120, 180, 208.

Study Arms (4)

Group C: Ad35.CS.01-10^10 vp/ml

EXPERIMENTAL

15 subjects will receive dosage 10\^10 vp/mL; 3 subjects will receive placebo.

Drug: PlaceboBiological: Ad35.CS.01 Circumsporozoite Malaria Vaccine

Group D: Ad35.CS.01-10^11 vp/ml

EXPERIMENTAL

15 subjects will receive dosage 10\^11 vp/mL; 3 subjects will receive placebo.

Drug: PlaceboBiological: Ad35.CS.01 Circumsporozoite Malaria Vaccine

Group A: Ad35.CS.01-10^8 vp/ml

EXPERIMENTAL

15 subjects will receive dosage 10\^8 vp/mL; 3 subjects will receive placebo.

Drug: PlaceboBiological: Ad35.CS.01 Circumsporozoite Malaria Vaccine

Group B: Ad35.CS.01-10^9 vp/ml

EXPERIMENTAL

15 subjects will receive dosage 10\^9 vp/mL; 3 subjects will receive placebo.

Drug: PlaceboBiological: Ad35.CS.01 Circumsporozoite Malaria Vaccine

Interventions

PlaceboDRUG

Normal saline.

Group A: Ad35.CS.01-10^8 vp/mlGroup B: Ad35.CS.01-10^9 vp/mlGroup C: Ad35.CS.01-10^10 vp/mlGroup D: Ad35.CS.01-10^11 vp/ml
Ad35.CS.01 Circumsporozoite Malaria VaccineBIOLOGICAL

Adenovirus Type 35 Circumsporozoite Malaria Vaccine (Ad35.CS.01); administered at 0, 1, and 6 months; dosage levels: 10\^8 viral particles (vp)/mL, 10\^9 vp/mL, 10\^10 vp/mL and 10\^11 vp/mL.

Group A: Ad35.CS.01-10^8 vp/mlGroup B: Ad35.CS.01-10^9 vp/mlGroup C: Ad35.CS.01-10^10 vp/mlGroup D: Ad35.CS.01-10^11 vp/ml

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of informed consent before any protocol procedures are performed.
  • Males and non-pregnant females between the ages of 18 and 45 years, inclusive.
  • Females and males must agree to practice adequate contraception until at least 28 days following their last immunization dose (including abstinence; hormonal contraception; condoms with spermicidal agents; post-menopausal; or surgical sterilization/vasectomy).
  • Participants must agree to avoid high risk sexual behavior for exposure to human immunodeficiency virus (HIV).
  • In good health as determined by screening medical history, physical examination (PE), and laboratory assessments.
  • Willingness to comply with protocol requirements.
  • Willingness to be contacted annually for five years for assessment of serious adverse events.
  • Must have access to a cell phone.

You may not qualify if:

  • Current or recent (within the last four weeks) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
  • History of splenectomy.
  • Abnormal screening laboratory values. Any abnormal screening value for any screening test will exclude the subject from the study. Abnormal screening labs will not be repeated with the exception of high glucose levels will be repeated at a fasting state.
  • Detectible neutralizing antibody titer against adenovirus serotype 35.
  • History of intravenous (IV) drug abuse.
  • History of, or current medical, occupational, social or family problems as a result of alcohol or illicit drug use.
  • History of moderate to severe mental illness, as defined by symptoms interfering with social or occupational function or suicidal thoughts/attempts.
  • History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
  • Vaccination with a live vaccine within the past 30 days or with a nonreplicating, inactivated, or subunit vaccine within the last 14 days.
  • Known hypersensitivity to components of the vaccine.
  • History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions.
  • History of coagulation defect or bleeding from (bruising at) multiple sites that cannot be linked to trauma or surgery.
  • History of anaphylaxis or severe hypersensitivity reaction.
  • Severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
  • Pregnant or breastfeeding women.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305-2200, United States

Location

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, 37232-2573, United States

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 22, 2014

Record last verified: 2014-06

Locations

US(2)