VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules
NCT ID: NCT03970993
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2019-06-17
2021-08-24
Brief Summary
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The study will assess the safety \& immune responses to vaccination, and the efficacy of the vaccine.
Detailed Description
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Arms 2a \& 2b receive 3 vaccinations at 0, 4 and 24 weeks. The protected volunteers in 2a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 3a and 3b receive 3 vaccinations at 0, 4 and 8 weeks. The protected volunteers in 3a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B.
Arms 4a and 4b will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Group 5 will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination.
Groups 6 \& 7 are control groups and will receive controlled human malaria infection (CHMI)
Healthy volunteers will be recruited in England across four research sites in Oxford, London, and Southampton.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1a
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart and an optional booster vaccination 12 months after the third dose
R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
R21 Matrix-M vaccination booster
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Group 2a
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge
R21 Matrix-M vaccination and CHMI
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
R21 Matrix-M vaccination booster
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Group 3a
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart, followed by CHMI by sporozoite challenge (mosquito bite) 4 weeks later. If protected from malaria, volunteers will receive an optional booster vaccination 28 days prior to malaria rechallenge
R21 Matrix-M vaccination and CHMI
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
R21 Matrix-M vaccination booster
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Group 4a
Volunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later
R21 Matrix-M vaccination and CHMI
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
Group 5
Volunteers will receive 2 doses of 10μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 2μg R21/50μg Matrix-M at 24 weeks. This is followed by optional CHMI by sporozoite challenge (mosquito bite) 4 weeks later
R21 Matrix-M vaccination and CHMI
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
Group 6
They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated.
No interventions assigned to this group
Group 7
They are infectivity control volunteers for the sporozoite challenge procedures: these volunteers are not vaccinated.
No interventions assigned to this group
Group 1b
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M, 4 weeks apart followed by an optional vaccination booster 12 months after the third dose.
R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
R21 Matrix-M vaccination booster
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Group 2b
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M at 0, 4 and 24 weeks.
R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
Group 3b
Volunteers will receive 3 doses of 10μg R21/50μg Matrix-M 4 weeks apart.
R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
Group 4b
Volunteers will receive 2 doses of 50μg R21/50μg Matrix-M 4 weeks apart and a 3rd fractional dose of 10μg R21/50μg Matrix-M at 24 weeks.
R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
Interventions
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R21 Matrix-M vaccination
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
R21 Matrix-M vaccination and CHMI
Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
R21 Matrix-M vaccination booster
Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Eligibility Criteria
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Inclusion Criteria
* Able and willing (in the Investigator's opinion) to comply with all study requirements.
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner.
* Women only: Must practice continuous effective contraception for the duration of the study.
* Agreement to refrain from blood donation during the course of the study.
* Agree to refrain from blood donation for at least 3 years after the end of their involvement in the study.\*
* Written informed consent to participate in the trial.
* Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.\*
* Willingness to take a curative anti-malaria regimen following CHMI.\*
* For volunteers not living close to the malaria challenge follow-up site (CCVTM, Oxford) agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).\*
* Answer all questions on the informed consent quiz correctly.\*
Exclusion Criteria
* Travel to a clearly malaria endemic locality during the study period or within the preceding six months
* Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim- sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)\*
* Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
* Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data as assessed by the investigator.
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
* Use of immunoglobulins or blood products within 3 months prior to enrolment.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products) or malaria infection.
* Any history of anaphylaxis post vaccination.
* History of clinically significant contact dermatitis.
* History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
* Pregnancy, lactation or intention to become pregnant during the study.
* Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone\*
* Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone\*
* Any clinical condition known to prolong the QT interval and existing contraindication to the use of Malarone.\*
* History of cardiac arrhythmia, including clinically relevant bradycardia and existing contraindication to the use of Malarone.\*
* Clinically significant disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia
* Family history of congenital QT prolongation or sudden death and existing contraindication to the use of Malarone.\*
* Contraindications to the use of both Riamet and Malarone\*
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
* History of serious psychiatric condition that may affect participation in the study.
* Any other serious chronic illness requiring hospital specialist supervision.
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
* Suspected or known injecting drug abuse in the 5 years preceding enrolment.
* Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
* Positive family history in both 1st and 2nd degree relatives \< 50 years old for cardiac disease.\*
* Volunteers unable to be closely followed for social, geographic or psychological reasons.
* Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
* Not applicable for volunteers who do not undergo CHMI (Groups 1, 4 and 5)
18 Years
45 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Adrian V Hill, DPhill FRCP
Role: PRINCIPAL_INVESTIGATOR
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
Locations
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Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
CCVTM, University of Oxford, Churchill Hospital
Oxford, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Other Identifiers
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VAC072
Identifier Type: -
Identifier Source: org_study_id