Who is sponsoring NCT01083095?

NCT01083095 is sponsored by Malaria Vaccine and Drug Development Center.

What drugs are being tested in NCT01083095?

Interventions in NCT01083095: Sporozoite Challenge Model for Plasmodium vivax in Humans.

What condition does NCT01083095 study?

NCT01083095 studies Malaria, Vivax.

Is NCT01083095 still recruiting?

NCT01083095 is currently completed. Last updated 8 March 2010.

Last reviewed 2010-03-08 · How we verify

NCT01083095: ChallengeII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Establishment of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Completed EARLY_PHASE1 Last updated 8 March 2010

What this trial tests

EARLY_PHASE1 trial testing Sporozoite Challenge Model for Plasmodium vivax in Humans in Malaria, Vivax in 18 participants. Completed in 1 December 2006.

Timeline

1 January 2005

Primary endpoint
1 March 2005

1 December 2006

Quick facts

Lead sponsor	Malaria Vaccine and Drug Development Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Enrollment	18
Start date	1 January 2005
Primary completion	1 March 2005
Estimated completion	1 December 2006
Sites	1 location across Colombia

Drugs / interventions tested

Sporozoite Challenge Model for Plasmodium vivax in Humans — full drug profile →

Conditions studied

Malaria, Vivax — all drugs for Malaria, Vivax →

Sponsor

Malaria Vaccine and Drug Development Center — full company profile →

Who can join

Adults 18 to 50, any sex, with Malaria, Vivax. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of infected naïve human volunteers after different number of infected mosquito biting
Time frame: 30 days

Sponsor's own description

A clinical trial aimed to standardize a vivax sporozoite infection model in human volunteers was conducted at the Malaria Vaccine and Drug Development Center (MVDC) in collaboration with the Immunology Institute at Valle State University and the Fundación Clínica Valle del Lili (FCVL) in Cali, Colombia. The primary objective was to determine if naïve human volunteers could be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands and a secondary objective consisted in determining the minimal number of infected mosquitoes required to infect all volunteers, with a reproducible pre-patent period. The trial was divided into two steps: Step A directed to obtain human blood infected with P.vivax parasite used to infect anopheles mosquitoes and Step B to produce P. vivax sporozoites in Anopheles mosquitoes to determine the dose response of naive human volunteers exposed to 3 +/- 1, 6 +/- 1 y 9 +/- 1 mosquitoes bites. A total of 15 samples of P. vivax infected donors were used to infect different batches of mosquitoes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Malaria, Vivax

Currently open trials in the same condition.

NCT06666491 — An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken · Phase 3 · recruiting
NCT05788094 — ACT vs CQ With Tafenoquine for P. Vivax Mono-infection · Phase 4 · recruiting

Other Malaria Vaccine and Drug Development Center trials

Trials by the same sponsor.

NCT07373301 — Phase IIa/b Trial of PvCS/Montanide ISA-51 Malaria Vaccine in Adults in Chocó, Colombia · Phase 2 · not yet recruiting
NCT04739917 — Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune V · Phase 2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01083095 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Malaria Vaccine and Drug Development Center
Last refreshed: 8 March 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01083095.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing