MalariaPhase 1/2NCT03707353
An Efficacy Study of IV Boosting With ChAd63/MVA ME-TRAP
A Phase 1/2 study testing ChAd63 ME-TRAP and MVA ME-TRAP vaccination in people with Malaria, run by University of Oxford at 4 sites in United Kingdom.
Trial summary
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- ChAd63 ME-TRAP and MVA ME-TRAP vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 30 Oct 2018to 10 Jun 2019
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 45 years
- 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
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent to participate in the trial.
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- Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
- Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
- Willingness to provide a named person who may be contacted in the event it is not possible to locate the volunteer following CHMI
- Willingness to take a curative anti-malaria regimen following CHMI.
- For volunteers not living in 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.
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
- 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. This may include non-malaria adenovirus vectored experimental vaccine. If any volunteers undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in the VAC066 trial.
- 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, Kathon) or malaria infection.
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- Any history of anaphylaxis post vaccination.
- History of clinically significant contact dermatitis.
- Pregnancy, lactation or intention to become pregnant during the study.
- 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 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).
- Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
- 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 (described in section 9.6.1).
- 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.
- Clinically significant disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia
- Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).
- History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
- 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.
- Contraindications to the use of both Riamet and Malarone.
- Any clinical condition known to prolong the QT interval and existing contraindication to the use of Malarone.
- Family history of congenital QT prolongation or sudden death and existing contraindication to the use of Malarone.
- History of cardiac arrhythmia, including clinically relevant bradycardia and existing contraindication to the use of Malarone.
- Positive family history in both 1st and 2nd degree relatives < 50 years old for cardiac disease.
- Volunteer unable to be closely followed for social, geographic or psychological reason.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
NIHR Clinical Research Facility, Hammersmith Hospital
London, W12 0HS
CCVTM, University of Oxford
Oxford, OX3 7LE
John Radcliffe Hospital
Oxford, OX3 9DU
Southampton National Institute for Health Research
Southampton, SO16 6YD
About this study
Official title: A Phase I/IIa Sporozoite Challenge Study to Assess the Safety, Immunogenicity and Protective Efficacy of Intravenous Boosting With Malaria Vaccine Candidates ChAd63 and MVA Encoding ME-TRAP
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and progressing towards global eradication, but those in clinical trials are currently someway short of WHO targets.
ChAd63 ME-TRAP and MVA ME-TRAP are leading candidate vaccines being developed by Adrian Hill's group at the University of Oxford, and collaborators. Since 2007, testing of these vaccines intramuscularly in over 900 volunteers has shown them to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying the efficacy of giving a boosting dose of the vaccines intravenously in what the investigators call a "prime-target" strategy. It follows very encouraging pre-clinical work showing this route can target desirable immune responses to the liver to fight a crucial stage of malaria infection. An ongoing recent phase I study is dose escalating both these vaccines intravenously as a single dose prior to commencing this trial where intramuscular and intravenous doses will be combined for the first time. The investigators will initially recruit 46 healthy UK adult volunteers who will be enrolled into 4 vaccination arms (10 volunteers each) and an unvaccinated control group (6 volunteers) who will undergo a controlled human malaria infection (CHMI). These are standardised, carefully supervised infection experiments used internationally to assess vaccine efficacy. As this is the first time giving intramuscular and intravenous doses of these vaccines in a combined schedule, the investigators will closely profile the safety and immune response during the vaccination follow-up. All trial activity will take place in Oxford.
Read the detailed description
The study is considered of low risk to the health of participants. Volunteers will receive investigational vaccines, be infected with malaria by mosquito bite, may develop clinical malaria disease, will be treated with antimalarial drugs, and will have blood taken regularly. They will also be given the option to undergo a minimally invasive procedure - Fine Needle Aspiration of the liver - to examine the immune response in this target organ which is also considered to be low risk.
As this is the first time intravenous dose of the vaccines following intramuscular prime/boost doses will be administered, once volunteers have received their intramuscular doses the investigators will stagger the intravenous vaccinations to allow for interim safety reviews. The first volunteer in groups 1\&2, once they have received their two intramuscular doses, will receive their intravenous vaccine dose alone and observed for a minimum 8 hours. If there have been no concerns identified at the 8 hour and 24 hour reviews identified by the CI and Local Safety Committee (LSC) chair, the next two volunteers in these groups will receive their intravenous vaccine dose. There will be a further safety 24 hours after these volunteers have been vaccinated before the remaining volunteers are vaccinated.
Volunteers are expected to have both vaccine site reactions (eg, pain, swelling, warmth in the arm where the vaccine is given) and systemic reactions to vaccination (eg, fever, headache, tiredness, sore muscles and joints). These are expected to resolve completely within several days, and symptoms strong enough to prevent usual activities over this time are expected to be uncommon.
- Conditions
- Malaria
- Being tested
- ChAd63 ME-TRAP and MVA ME-TRAP vaccination
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd63 ME-TRAP and MVA ME-TRAP vaccinationBiological
vaccination with ChAd63 ME-TRAP 5x10^10 vp (intramuscularly and intravenously) vaccination with MVA METRAP 2x10^8 pfu (intramuscularly) and MVA METRAP 2x10^7 pfu (intravenously) Group 5 will be challenged with malaria by mosquito bite.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Volunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by ChAd63 ME-TRAP vaccination intravenously. Receives: Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccination |
| Group 2 | Experimental | Volunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by MVA ME-TRAP vaccination intravenously. Receives: Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccination |
| Group 3 | Experimental | Volunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, followed by ChAd63 ME-TRAP vaccination intravenously. Receives: Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccination |
| Group 4 | Experimental | Volunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, followed by MVA ME-TRAP vaccination intravenously. 4 weeks after the last vaccine dose, all vaccinated volunteers will undergo malaria challenge by mosquito bite. Receives: Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccination |
| Group 5 | No intervention | 6 Volunteers will receive no vaccinations but will undergo malaria challenge infection by mosquito bite at the same time as groups 1-4. |
| Group 6 | No intervention | 6 Volunteers will be used as infectivity controls if any volunteers from Groups 1-4 are rechallenged 5 - 7 months after the initial CHMI. |
| Group A | Experimental | Volunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by MVA ME-TRAP vaccination intravenously. Receives: Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve volunteers, assessed by frequency of adverse events
Occurrence of solicited and unsolicited local and systemic adverse events
Measured: Solicited and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period (16 weeks following completion of the prime target regimen)
Secondary outcomes (1)
To assess cell-mediated immunogenicity generated in malaria naïve individuals of vaccination schedules incorporating intramuscular prime dose(s) followed by intravenous booster with ChAd63 and MVA encoding ME-TRAP.
The key measure of immunogenicity will be ELISPOT to enumerate IFN-γ producing T cells.
Measured: Up to 11-13 months from initial vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Oct 2018
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V Hill, DPhill FRCP, Principal investigator, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707353
- Sponsor's protocol ID
- VAC066
- Status last verified
- Jul 2019
- First submitted
- 10 Oct 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Sporozoite Challenge Study to Assess the Safety, Immunogenicity and Protective Efficacy of Intravenous Boosting With Malaria Vaccine Candidates ChAd63 and MVA Encoding ME-TRAP
- ClinicalTrials.gov ID
- NCT03707353
- Acronym / sponsor ID
- VAC066
- Conditions
- Malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 16 Oct 2018 (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.
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and progressing towards global eradication, but those in clinical trials are currently someway short of WHO targets.
ChAd63 ME-TRAP and MVA ME-TRAP are leading candidate vaccines being developed by Adrian Hill's group at the University of Oxford, and collaborators. Since 2007, testing of these vaccines intramuscularly in over 900 volunteers has shown them to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying the efficacy of giving a boosting dose of the vaccines intravenously in what the investigators call a "prime-target" strategy. It follows very encouraging pre-clinical work showing this route can target desirable immune responses to the liver to fight a crucial stage of malaria infection. An ongoing recent phase I study is dose escalating both these vaccines intravenously as a single dose prior to commencing this trial where intramuscular and intravenous doses will be combined for the first time. The investigators will initially recruit 46 healthy UK adult volunteers who will be enrolled into 4 vaccination arms (10 volunteers each) and an unvaccinated control group (6 volunteers) who will undergo a controlled human malaria infection (CHMI). These are standardised, carefully supervised infection experiments used internationally to assess vaccine efficacy. As this is the first time giving intramuscular and intravenous doses of these vaccines in a combined schedule, the investigators will closely profile the safety and immune response during the vaccination follow-up. All trial activity will take place in Oxford.
Detailed description
The study is considered of low risk to the health of participants. Volunteers will receive investigational vaccines, be infected with malaria by mosquito bite, may develop clinical malaria disease, will be treated with antimalarial drugs, and will have blood taken regularly. They will also be given the option to undergo a minimally invasive procedure - Fine Needle Aspiration of the liver - to examine the immune response in this target organ which is also considered to be low risk.
As this is the first time intravenous dose of the vaccines following intramuscular prime/boost doses will be administered, once volunteers have received their intramuscular doses the investigators will stagger the intravenous vaccinations to allow for interim safety reviews. The first volunteer in groups 1\&2, once they have received their two intramuscular doses, will receive their intravenous vaccine dose alone and observed for a minimum 8 hours. If there have been no concerns identified at the 8 hour and 24 hour reviews identified by the CI and Local Safety Committee (LSC) chair, the next two volunteers in these groups will receive their intravenous vaccine dose. There will be a further safety 24 hours after these volunteers have been vaccinated before the remaining volunteers are vaccinated.
Volunteers are expected to have both vaccine site reactions (eg, pain, swelling, warmth in the arm where the vaccine is given) and systemic reactions to vaccination (eg, fever, headache, tiredness, sore muscles and joints). These are expected to resolve completely within several days, and symptoms strong enough to prevent usual activities over this time are expected to be uncommon.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccinationVolunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by ChAd63 ME-TRAP vaccination intravenously. |
| Group 2 | Experimental | Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccinationVolunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by MVA ME-TRAP vaccination intravenously. |
| Group 3 | Experimental | Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccinationVolunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, followed by ChAd63 ME-TRAP vaccination intravenously. |
| Group 4 | Experimental | Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccinationVolunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, followed by MVA ME-TRAP vaccination intravenously. 4 weeks after the last vaccine dose, all vaccinated volunteers will undergo malaria challenge by mosquito bite. |
| Group 5 | No intervention | –6 Volunteers will receive no vaccinations but will undergo malaria challenge infection by mosquito bite at the same time as groups 1-4. |
| Group 6 | No intervention | –6 Volunteers will be used as infectivity controls if any volunteers from Groups 1-4 are rechallenged 5 - 7 months after the initial CHMI. |
| Group A | Experimental | Biological: ChAd63 ME-TRAP and MVA ME-TRAP vaccinationVolunteers will receive ChAd63 ME-TRAP vaccination intramuscularly, then MVA ME-TRAP vaccination intramuscularly followed by MVA ME-TRAP vaccination intravenously. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adults aged 18 to 45 years
- 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
- For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (30 listed)
- History of clinical malaria (any species).
- Travel to a clearly malaria endemic locality during the study period or within the preceding six months
- 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. This may include non-malaria adenovirus vectored experimental vaccine. If any volunteers undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in the VAC066 trial.
- 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).
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 |
|---|---|---|
| ChAd63 ME-TRAP and MVA ME-TRAP vaccinationvaccination with ChAd63 ME-TRAP 5x10^10 vp (intramuscularly and intravenously) vaccination with MVA METRAP 2x10^8 pfu (intramuscularly) and MVA METRAP 2x10^7 pfu (intravenously) Group 5 will be challenged with malaria by mosquito bite. | Biological | Group 1, Group 2, Group 3, Group 4, Group A |
Primary outcome
Efficacy and safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve volunteers, assessed by frequency of adverse events
Time frame: Solicited and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period (16 weeks following completion of the prime target regimen)
Occurrence of solicited and unsolicited local and systemic adverse events
1 secondary outcome
To assess cell-mediated immunogenicity generated in malaria naïve individuals of vaccination schedules incorporating intramuscular prime dose(s) followed by intravenous booster with ChAd63 and MVA encoding ME-TRAP.
Time frame: Up to 11-13 months from initial vaccination
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 26 Sep 2019.
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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.
Adrian V Hill, DPhill FRCP principal investigator
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAd63 ME-TRAP and MVA ME-TRAP vaccination in people with Malaria, run by University of Oxford at 4 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 12 inclusion and 30 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy and safety of intramuscular vaccination followed by intravenous boosting with ChAd63 and MVA encoding ME-TRAP, in healthy malaria-naïve volunteers, assessed by frequency of adverse events (time frame: Solicited and Unsolicited AEs will be collected for 28 days. SAEs will be collected from enrolment until the end of the follow-up period (16 weeks following completion of the prime target regimen)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2019.