Malaria, VivaxVAC068NCT03377296
Study of Controlled Human Plasmodium Vivax Infection
A study testing Plasmodium vivax infection and Collection of 250mL blood from each volunteer (N=2) in people with Malaria, Vivax, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Vivax
- What is being tested?
- Plasmodium vivax infection and Collection of 250mL blood from each volunteer (N=2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Mar 2018to 13 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Healthy adult aged 18 to 50 years.
- Blood group O, Rhesus negative.
- Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
- High metaboliser of primaquine (as determined by CYP2D6 genotype).
- Normal serum levels of Glucose-6-phosphate dehydrogenase (G6PDH).
- Satisfactory serum levels of Primaquine (when administered as test dose).
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- 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 clinic visits (first 3 months post-CHMI).
- Agreement to refrain from blood donation during the course of the study and for at least 5 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 all antimalarial treatment.
- Willing to take a curative anti-malaria regimen following CHMI.
- Willing to be admitted to the research bay on the John Warin ward at the Churchill Hospital for blood donation and clinical monitoring, until antimalarial treatment is underway and their symptoms are settling.
- Willing to reside in Oxford for the duration of the study, until all antimalarials have been completed.
- Answer all questions on the informed consent quiz correctly. * Female volunteers are required to use an effective form of contraception during the course of the study as malaria challenge could pose a serious risk to both maternal health and the unborn foetus.
- Acceptable forms of contraception for female volunteers include:
- Established use of oral, injected or implanted hormonal methods of contraception (an additional form of contraception will be required when taking the antimalarial medication, as this can interfere with the efficacy of hormonal contraception).
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Total abdominal hysterectomy.
- Barrier methods of contraception (condom or occlusive cap with spermicide).
- Male sterilisation, if the vasectomised partner is the sole partner for the subject.
- True abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception).
Who cannot join
- • History of clinical malaria (any species).
- 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).
- Blood group A/B and/or Rhesus positive.
- Red blood cells negative for the Duffy antigen/chemokine receptor (DARC).
- Glucose-6-phosphate dehydrogenase (G6PDH) deficient.
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- Inadequate serum levels of Primaquine (when administered as test dose).
- Current anaemia (Haemoglobin < 9 g/dL).
- Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
- History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
- Venepuncture unlikely to allow a 250 mL blood donation (as determined by the Investigator).
- 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 or the P. vivax parasite 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).
- History of allergic disease or reactions likely to be exacerbated by 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.
- History of cardiac arrhythmia, including clinically relevant bradycardia.
- Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- Family history of congenital QT prolongation or sudden death.
- Contraindications to the use of both of the proposed anti-malarial medications; Riamet Malarone.
- Contraindications to the use of Primaquine.
- 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 42 standard UK units every week.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Hepatitis B surface antigen (HBsAg) detected in serum.
- Seropositive for HTLV I or II (antibodies to HTLV) at screening.
- 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).
- Seropositive for RPR (antibodies to syphilis) at screening.
- 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 clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria are shown in Appendix A.
- 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.
- Testing for HIV, HTLV, hepatitis B and C and syphilis will be performed at screening and then repeated 1 week prior to CHMI (day C-7) to ensure no new acquisition of infection prior to blood donation. Other infections will be screened for if the volunteer has recently travelled to an area where they may have been exposed to a blood-borne infection that could theoretically be transmitted to another healthy volunteer during a future blood-stage challenge.
- Exclusion criteria on day of CHMI
- The following constitute absolute contraindications to CHMI:
- Acute disease, defined as moderate or severe illness with or without fever.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Clinical Vaccinology & Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
John Warin Ward, Oxford University NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Clinical Study to Assess the Safety of Controlled Human Plasmodium Vivax Malaria Infection Through Experimental Sporozoite Infection of Healthy Malaria-naïve UK Adults, and to Characterise Parasite Growth and Immune Responses to P.Vivax
This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.
Read the detailed description
This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.
Two healthy, malaria-naïve adults aged between 18 and 50 years will be recruited at the CCVTM, Oxford. CHMI by sporozoites will be delivered by mosquito bite at Imperial College, London, and follow-up during the post-challenge period will be at the CCVTM in Oxford.
The two volunteers will have blood taken at regular intervals post-CHMI to assess the immune response to primary P. vivax infection, and also the gametocytaemia following P. vivax infection, and the volunteers will be monitored closely until the volunteers meet the criteria for treatment. Up to 250 mL (half a unit) of blood will be taken just prior to treatment from the two successfully infected volunteers (as determined by measurement of the parasitaemia) and frozen down for future use in blood-stage CHMI trials. The volunteers will be treated with a standard 60-hour course of oral artemether-lumefantrine (Riamet) followed by a 2-week course of partially-observed oral Primaquine for radical cure of P. vivax hypnozoites. The volunteers will be followed up for 3 months in the clinic and email follow-up will continue out to 5 years to monitor for clinical relapse.
- Conditions
- Malaria, Vivax
- Being tested
- Plasmodium vivax infection, Collection of 250mL blood from each volunteer (N=2)
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmodium vivax infectionOther
Two healthy human volunteers are exposed to the bites of five infectious mosquitoes per participant (by placing their forearms over the pot containing mosquitoes) for 5-10 minutes. Fed mosquitoes (as indicated by the presence of a blood meal in the abdomen) are individually dissected and assessed for sporozoite load (graded 0 to +4; a gland rating of +2 or more, representing 10 or more observed sporozoites, qualifies as being infectious). If, by this method the volunteer is found to have been inoculated by less than five infected mosquitoes, further mosquitoes are allowed to feed on the volunteer until a total of 5 appropriately infected mosquitoes have fed. The bite-challenge procedure continues until the subject has been bitten by 5 infectious mosquitoes.
Collection of 250mL blood from each volunteer (N=2)Procedure or surgery
Collection of 250mL of P. vivax-infected blood from each volunteer when a threshold parasitaemia/ symptoms are met
| Study group | Role | What they receive |
|---|---|---|
| Plasmodium Vivax infection | Experimental | Both volunteers will be infected with Plasmodium Vivax (as described below in full in "Interventions"). i.e., there is only one arm to this study. Receives: Other: Plasmodium vivax infection; Procedure: Collection of 250mL blood from each volunteer (N=2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of (Serious) Adverse Events following P. vivax CHMI
Safety of P. vivax CHMI, as measured by incidence of (Serious) Adverse Events (Safety and Tolerability)
Measured: Up to 21 days post challenge
Clinical symptoms of malaria infection post CHMI
Measure of successful infection (development of clinical symptoms of malaria)
Measured: Up to 21 days post challenge
Parasitaemia post CHMI
Measure of successful infection (development of detectable persistent parasitaemia) symptoms).
Measured: Up to 90 days post challenge
Immune response to P. vivax
Immune response to P. vivax, as measured by antibody, B cell and T cell responses.
Measured: Up to 90 days post challlenge
Gametocytaemia
Gametocytaemia, as measured by qPCR
Measured: Up to 90 days post challenge
Secondary outcomes (1)
Collection and freezing down of P. vivax-infected blood.
Collection and freezing down of up to 250 mL P. vivax-infected blood from 2 volunteers.
Measured: Collected between day 8 and day 14 post challenge, determined by symptoms and parasitaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start3 Mar 2018
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, VivaxStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela M Minassian, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377296
- Sponsor's protocol ID
- VAC068
- Other IDs
- 228948
- Acronym
- VAC068
- Status last verified
- Jun 2023
- First submitted
- 7 Dec 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Minassian AM, Themistocleous Y, Silk SE, Barrett JR, Kemp A, Quinkert D, Nielsen CM, Edwards NJ, Rawlinson TA, Ramos Lopez F, Roobsoong W, Ellis KJ, Cho JS, Aunin E, Otto TD, Reid AJ, Bach FA, Labbe GM, Poulton ID, Marini A, Zaric M, Mulatier M, Lopez Ramon R, Baker M, Mitton CH, Sousa JC, Rachaphaew N, Kumpitak C, Maneechai N, Suansomjit C, Piteekan T, Hou MM, Khozoee B, McHugh K, Roberts DJ, Lawrie AM, Blagborough AM, Nugent FL, Taylor IJ, Johnson KJ, Spence PJ, Sattabongkot J, Biswas S, Rayner JC, Draper SJ. Controlled human malaria infection with a clone of Plasmodium vivax with high-quality genome assembly. JCI Insight. 2021 Dec 8;6(23):e152465. doi: 10.1172/jci.insight.152465.
PubMed 34609964
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Safety of Controlled Human Plasmodium Vivax Malaria Infection Through Experimental Sporozoite Infection of Healthy Malaria-naïve UK Adults, and to Characterise Parasite Growth and Immune Responses to P.Vivax
- ClinicalTrials.gov ID
- NCT03377296
- Acronym / sponsor ID
- VAC068 / VAC068
- Conditions
- Malaria, Vivax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.
Detailed description
This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.
Two healthy, malaria-naïve adults aged between 18 and 50 years will be recruited at the CCVTM, Oxford. CHMI by sporozoites will be delivered by mosquito bite at Imperial College, London, and follow-up during the post-challenge period will be at the CCVTM in Oxford.
The two volunteers will have blood taken at regular intervals post-CHMI to assess the immune response to primary P. vivax infection, and also the gametocytaemia following P. vivax infection, and the volunteers will be monitored closely until the volunteers meet the criteria for treatment. Up to 250 mL (half a unit) of blood will be taken just prior to treatment from the two successfully infected volunteers (as determined by measurement of the parasitaemia) and frozen down for future use in blood-stage CHMI trials. The volunteers will be treated with a standard 60-hour course of oral artemether-lumefantrine (Riamet) followed by a 2-week course of partially-observed oral Primaquine for radical cure of P. vivax hypnozoites. The volunteers will be followed up for 3 months in the clinic and email follow-up will continue out to 5 years to monitor for clinical relapse.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasmodium Vivax infection | Experimental | Other: Plasmodium vivax infection, Procedure: Collection of 250mL blood from each volunteer (N=2)Both volunteers will be infected with Plasmodium Vivax (as described below in full in "Interventions"). i.e., there is only one arm to this study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- • Healthy adult aged 18 to 50 years.
- Established use of oral, injected or implanted hormonal methods of contraception (an additional form of contraception will be required when taking the antimalarial medication, as this can interfere with the efficacy of hormonal contraception).
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Total abdominal hysterectomy.
- Barrier methods of contraception (condom or occlusive cap with spermicide).
Key exclusion criteria (42 listed)
- • History of clinical malaria (any species).
- Testing for HIV, HTLV, hepatitis B and C and syphilis will be performed at screening and then repeated 1 week prior to CHMI (day C-7) to ensure no new acquisition of infection prior to blood donation. Other infections will be screened for if the volunteer has recently travelled to an area where they may have been exposed to a blood-borne infection that could theoretically be transmitted to another healthy volunteer during a future blood-stage challenge.
- Exclusion criteria on day of CHMI
- Acute disease, defined as moderate or severe illness with or without fever.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmodium vivax infectionTwo healthy human volunteers are exposed to the bites of five infectious mosquitoes per participant (by placing their forearms over the pot containing mosquitoes) for 5-10 minutes. Fed mosquitoes (as indicated by the presence of a blood meal in the abdomen) are individually dissected and assessed for sporozoite load (graded 0 to +4; a gland rating of +2 or more, representing 10 or more observed sporozoites, qualifies as being infectious). If, by this method the volunteer is found to have been inoculated by less than five infected mosquitoes, further mosquitoes are allowed to feed on the volunteer until a total of 5 appropriately infected mosquitoes have fed. The bite-challenge procedure continues until the subject has been bitten by 5 infectious mosquitoes. | Other | Plasmodium Vivax infection |
| Collection of 250mL blood from each volunteer (N=2)Collection of 250mL of P. vivax-infected blood from each volunteer when a threshold parasitaemia/ symptoms are met | Procedure or surgery | Plasmodium Vivax infection |
Primary outcome
Incidence of (Serious) Adverse Events following P. vivax CHMI
Time frame: Up to 21 days post challenge
Safety of P. vivax CHMI, as measured by incidence of (Serious) Adverse Events (Safety and Tolerability)
Clinical symptoms of malaria infection post CHMI
Time frame: Up to 21 days post challenge
Measure of successful infection (development of clinical symptoms of malaria)
Parasitaemia post CHMI
Time frame: Up to 90 days post challenge
Measure of successful infection (development of detectable persistent parasitaemia) symptoms).
Immune response to P. vivax
Time frame: Up to 90 days post challlenge
Immune response to P. vivax, as measured by antibody, B cell and T cell responses.
Gametocytaemia
Time frame: Up to 90 days post challenge
Gametocytaemia, as measured by qPCR
1 secondary outcome
Collection and freezing down of P. vivax-infected blood.
Time frame: Collected between day 8 and day 14 post challenge, determined by symptoms and parasitaemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 34609964Minassian AM, Themistocleous Y, Silk SE, Barrett JR, Kemp A, Quinkert D, Nielsen CM, Edwards NJ, Rawlinson TA, Ramos Lopez F, Roobsoong W, Ellis KJ, Cho JS, Aunin E, Otto TD, Reid AJ, Bach FA, Labbe GM, Poulton ID, Marini A, Zaric M, Mulatier M, Lopez Ramon R, Baker M, Mitton CH, Sousa JC, Rachaphaew N, Kumpitak C, Maneechai N, Suansomjit C, Piteekan T, Hou MM, Khozoee B, McHugh K, Roberts DJ, Lawrie AM, Blagborough AM, Nugent FL, Taylor IJ, Johnson KJ, Spence PJ, Sattabongkot J, Biswas S, Rayner JC, Draper SJ. Controlled human malaria infection with a clone of Plasmodium vivax with high-quality genome assembly. JCI Insight. 2021 Dec 8;6(23):e152465. doi: 10.1172/jci.insight.152465.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Minassian principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmodium vivax infection and Collection of 250mL blood from each volunteer (N=2) in people with Malaria, Vivax, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of (Serious) Adverse Events following P. vivax CHMI (time frame: Up to 21 days post challenge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.