Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01031524

Acronym

DG002

Enrollment

Registered

2009-12-14

Start date

2004-03-31

Completion date

2004-11-30

Last updated

2009-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Falciparum Malaria

Keywords

Plasmodium falciparum malaria

Brief summary

Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.

Interventions

BIOLOGICALPfCS102

Antigen of the sporozoite protein

BIOLOGICALMontanide ISA 720

adjuvant alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* resident in or near Lausanne; * age \>18 and \<45 years; * written informed consent; * \>10/12 correct responses to the questionnaire of understanding.

Exclusion criteria

* history of malaria; possible exposure to malaria within the previous 6 months; * positive serology for PfCS102by ELISA; * history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines; * pregnant or lactating female; * any confirmed or suspected immunodeficient condition; * seropostivity for HIV; * chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease; * hemoglobinopathies; * history of \>2 hospitalisations for invasive bacterial infections; * requirement of any chronic medication; * suspected or known current alcohol or illegal drug abuse (excluding cannabis); * any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study; * a body mass index \< 18kg/m2 or \> 32 kg/m2; * evidence of past or present psychiatric condition; * seropositivity for HIV, hepatitis C or B (other than HBs Ab); * 10-year risk of coronary heart disease \<10%; * any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.

Design outcomes

Primary

Measure	Time frame
Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy	1month

Secondary

Measure	Time frame
Incidence of adverse events	15 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026