Study to Investigate the Induction of an Protective Immune Response to Malaria

NCT00442377 | Completed

• 1 other identifier: EHMI-8
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to induce a protective immune response against malaria in healthy human volunteers. The different parts of the immune response will then be studied.

Conditions

Falciparum Malaria

Keywords

Falciparum; Plasmodium; Malaria

Outcome Measures

Primary Outcomes (4)

• A significant difference in time of thick smear positivity between exposed and control groups

• A significant difference in parasitemia as measured by 18S Pf NASBA between exposed and control group

• A significant difference in kinetics of parasitemia between exposed and control groups as measured by 18S Pf NASBA.

• A difference in occurrence or height of fever between exposed and control groups.

Secondary Outcomes (6)

• Significant differences in immune response between exposed and control volunteers (including NK-cell reactivity, TLR reactivity and regulatory T-cell reactivity)

• Significant differences in the outcome of in vitro functional malaria assays between exposed and control volunteers

• Significant differences in cellular reactivity against Pf antigens

• Significant differences in parasite VAR gene expression during infection

• The identification of immune mechanisms that correlate with protection

Interventions

exposure to malaria sporozoites PROCEDURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 and \< 45 years healthy volunteers (males or females).
• General good health based on history and clinical examination.
• All volunteers have to sign the informed consent form.
• Negative pregnancy test.
• Use of adequate contraception for females
• Reachable by phone during the whole study period.
• Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial

You may not qualify if:

• History of malaria or residence in malaria endemic areas within the past six months.
• Positive serology for P. falciparum
• Previously participated in any malaria vaccine study
• Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
• Cardiovascular risk \>10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes
• Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests.
• Volunteers should not be enrolled in any other clinical trial during the whole trial period.
• Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period.
• Pregnant or lactating women.
• Volunteers unable to give written informed consent.
• Volunteers unable to be closely followed for social, geographic or psychological reasons.
• Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study.
• Known hypersensitivity for anti-malaria drugs
• Volunteers are not allowed to travel to malaria endemic countries during the study period.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

• Coffeng LE, Hermsen CC, Sauerwein RW, de Vlas SJ. The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection. PLoS Comput Biol. 2017 Jan 12;13(1):e1005255. doi: 10.1371/journal.pcbi.1005255. eCollection 2017 Jan.

  PMID: 28081133 DERIVED

• Roestenberg M, McCall M, Hopman J, Wiersma J, Luty AJ, van Gemert GJ, van de Vegte-Bolmer M, van Schaijk B, Teelen K, Arens T, Spaarman L, de Mast Q, Roeffen W, Snounou G, Renia L, van der Ven A, Hermsen CC, Sauerwein R. Protection against a malaria challenge by sporozoite inoculation. N Engl J Med. 2009 Jul 30;361(5):468-77. doi: 10.1056/NEJMoa0805832.

  PMID: 19641203 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Sauerwein, Prof

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: January 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 16, 2007

Record last verified: 2007-08

Locations

NL (1)