NCT00374998

CompletedPhase 1

Safety and Immunogenicity Study of the Malaria Vaccines FP9 ...

European Vaccine Initiative Source

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Other study identifiers

Sponsor study identifier

VAC027.1

Secondary identifiers

EudraCT number: 2004-002424-17

EMVI trial identifier: PP_1_04

Study Type

interventional

Reported enrollment (type unavailable)

35

Locations

1 country

Sites

1

Timeline

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

January 2007

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 35 participants
Study completion date: January 2007
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 10, 2006
Actual (reported)
First Posted
September 12, 2006
Actual (reported)
Study Completion
January 2007
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: March 1, 2007
Status Verified: February 2007
Last Update Submitted: February 28, 2007

Conditions

Malaria Malaria, Falciparum

Keywords

MalariaVaccinePrime-boost

Outcome Measures

Primary Outcomes (3)

Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)

Secondary Outcomes (3)

T-cell immunogenicity (prime-boost groups)
Humoral immunogenicity (prime-boost groups)
Gene expression (prime-boost groups)

Interventions

FP9-PP (FP9 polyprotein)Biological

MVA-PP (Modified Virus Ankara polyprotein)Biological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adults aged 18 to 50 years
Resident in or near Oxford, UK for the duration of the vaccination study

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Oxford, OX3 7LJ, United Kingdom

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

Adrian VS Hill, MA, BM BCh, DPhil, DM
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

Study Record Dates

First Submitted

September 10, 2006

First Posted

September 12, 2006

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

January 2007

Date type not reported

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Willingness to allow the investigators to access hospital and General Practitioner medical notes

For females only, willingness to practice continuous effective contraception during the study and if participating, during the subsequent challenge study.

Agreement to refrain from blood donation during the course of the study

Written informed consent

Willingness to undergo an HIV test

You may not qualify if:

Any deviation from the protocol-defined normal range in biochemistry or haematology blood tests or in urine analysis
Prior receipt of an investigational malaria vaccine
Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination
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
Any history of malaria
Travel to a malaria endemic country within the previous 6 months prior to the planned challenge
Planned travel to malarious areas during the study period
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
Evidence of cardiovascular disease
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
History of haemoglobinopathies
History of diabetes mellitus
Chronic or active neurological disease
+8 more criteria

Contact the study team to confirm eligibility.

Othercollaborator

This date has not been verified as actual or estimated.

Last Updated

March 1, 2007

Record last verified: 2007-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00374998
Data provider: ClinicalTrials.gov
Source updated: 2007-03-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:30 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations