A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria

NCT00984763 | Completed Phase 1 DMC

• 1 other identifier: VAC035
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle. The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response. This study will enable the investigators to assess:

1. 1.The ability of of a growth inhibition assay to predict the effectiveness of a malaria vaccine.
2. 2.The safety of the vaccine in healthy volunteers
3. 3.The response of the human immune system to the vaccine

Conditions

Malaria

Keywords

Malaria; Vaccine

Outcome Measures

Primary Outcomes (1)

• To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo

  Up to 16 days following blood stage parasite challenge

Secondary Outcomes (1)

• To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel® + CPG 7909

  Up to 16 days following blood stage parasite challenge

Study Arms (2)

Group 1

EXPERIMENTAL

AMA1-C1/Alhydrogel® + CPG 7909 vaccine given twice two months apart followed by malaria parasite challenge

Biological: AMA1-C1/Alhydrogel® + CPG 7909

Group 2

NO INTERVENTION

Control: malaria parasite challenge without prior vaccinations

Interventions

AMA1-C1/Alhydrogel® + CPG 7909 BIOLOGICAL

A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909)

Group 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is willing and able to give informed consent for participation in the study
• Healthy, non pregnant adult aged 18 - 50 years
• Resident in or near Oxford for the duration of the challenge study
• Seropositive for CMV and EBV
• Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study
• Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination
• Able (in the Investigator's opinion) and willing to comply with all study requirements
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
• Agreement to permanently refrain from blood donation.

You may not qualify if:

• Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B
• Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study
• Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
• Subjects who have previously received an investigational malaria vaccine
• History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
• Travel to a malaria endemic area within the previous 6 months
• Planned travel to malarious areas during the study period
• Any history of malaria
• Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
• concomitant use of other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
• An estimated ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system (Conroy 2003)
• Family history of sudden cardiac death
• History of cardiac arrhythmia or prolonged QT syndrome
• Any history of severe allergic reaction or anaphylaxis
• History of a known allergy to nickel

Sponsors & Collaborators

• University of Oxford: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, Headington, United Kingdom

Location

Related Publications (1)

• Duncan CJ, Sheehy SH, Ewer KJ, Douglas AD, Collins KA, Halstead FD, Elias SC, Lillie PJ, Rausch K, Aebig J, Miura K, Edwards NJ, Poulton ID, Hunt-Cooke A, Porter DW, Thompson FM, Rowland R, Draper SJ, Gilbert SC, Fay MP, Long CA, Zhu D, Wu Y, Martin LB, Anderson CF, Lawrie AM, Hill AV, Ellis RD. Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909. PLoS One. 2011;6(7):e22271. doi: 10.1371/journal.pone.0022271. Epub 2011 Jul 22.

  PMID: 21799809 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

ProMune

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Adrian VS Hill, D.Phil, FRCP

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

GB (1)