Plasmodium Falciparum MalariaPhase 1/2NCT02252640

A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

A Phase 1/2 study testing RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01) and ChAd63 ME-TRAP (5 x 10^10 vp) in people with Plasmodium Falciparum Malaria, run by University of Oxford at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess: 1. The ability of the vaccines to prevent malaria infection. 2. The safety of the vaccines in healthy participants. 3. The response of the human immune system to the vaccines. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Plasmodium Falciparum Malaria
What is being tested?: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01) and ChAd63 ME-TRAP (5 x 10^10 vp)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 4 sitesUnited Kingdom
Study dates: Jan 2015to Oct 2015
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.
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 and for at least 3 years after the end of their involvement in the study.
Written informed consent to participate in the trial.

Show all 10Show fewer

Reachable (24/7) by mobile phone during the period between Controlled Human Malaria Infection (CHMI) and completion of antimalarial treatment.
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 malaria endemic region during the study period or within the preceding six months with significant risk of malaria exposure.
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 malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data. If any volunteers in Group 1-4 undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in this 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).

Show all 31Show fewer

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.
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
History of cardiac arrhythmia, including clinically relevant bradycardia
Disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia
Family history of congenital QT prolongation or sudden death
Contraindications to the use of all three proposed anti-malarial medications; Riamet, Malarone and Chloroquine.
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).
An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.59
Positive family history in 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.
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.

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

Surrey Clinical Research Centre, University of Surrey
Guildford, Surrey, GU2 7XP
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital, Imperial College NHS Trust
London, W12 0HS
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Oxfordshire, OX3 7LE
NIHR WTCRF, University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA Encoding ME-TRAP and Also RTS,S/AS01B Alone

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess:

The ability of the vaccines to prevent malaria infection.
The safety of the vaccines in healthy participants.
The response of the human immune system to the vaccines.

We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccine combination provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. We will also recruit 4 individuals to be control subjects - these participants won't receive any vaccinations but will be challenged with malaria.

Vaccinated volunteers who do not develop malaria infection in the blood after being infected with malaria by mosquito bite the first time may be invited back to be again infected with malaria in a repeat challenge experiment. This would happen approximately 5-7 months after the first challenge. The purpose of this second challenge will be to see how long the protection of the investigational vaccine against malaria lasts.

Conditions: Plasmodium Falciparum Malaria
Being tested: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01), ChAd63 ME-TRAP (5 x 10^10 vp), MVA ME-TRAP (2 x 10^8 pfu)
Keywords: Plasmodium Falciparum, Malaria, Vaccine, Plasmodium, Falciparum
Medical subject headings: Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)Biological
RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)Biological
ChAd63 ME-TRAP (5 x 10^10 vp)Biological
MVA ME-TRAP (2 x 10^8 pfu)Biological

Study groups in NCT02252640
Study group	Role	What they receive
Group 1	Active comparator	Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers. Receives: Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)
Group 2	Active comparator	Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers. Receives: Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01); Biological: RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)
Group 3	Active comparator	Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers. Receives: Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01); Biological: ChAd63 ME-TRAP (5 x 10^10 vp); Biological: MVA ME-TRAP (2 x 10^8 pfu)
Group 4	Active comparator	Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers. Receives: Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01); Biological: RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01); Biological: ChAd63 ME-TRAP (5 x 10^10 vp); Biological: MVA ME-TRAP (2 x 10^8 pfu)
Group 5	No intervention	Week 11: Controlled Human Malaria Infection
Group 6	No intervention	Week 31-39: Controlled Human Malaria Infection

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
Use statistical analysis to compare number of completely protected individuals (those who do not, by Day 23 following sporozoite challenge, develop blood stage infection measured by occurrence of P. falciparum parasitemia, assessed by blood slide)
Measured: 6 months
Safety of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
Occurrence of solicited and unsolicited adverse events will be monitored. Solicited and unsolicited AE data will be collected at each clinic visit. It will be collected from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups.
Measured: 6 months

Secondary outcomes (1)

Immunogenicity generated in malaria naïve individuals of two different dosing regimens of RTS,S/AS01B given concomitantly with ChAd63/MVA ME-TRAP, and of RTS,S/AS01B alone at either full standard dose or with a reduced third dose.
To document immunogenicity measures, capturing humoral and cellular immune responses to both ChAd63/MVA ME-TRAP and RTS,S as follows: Anti-CS (RT, C-term, full-length), anti-HBs, and anti-ME-TRAP antibody titers; frequency of CS-specific, HBs-specific, and TRAP and ME specific T cells; ChAd63 neutralizing antibody titers; avidity index of anti-CS antibodies. To undertake exploratory analysis of the correlation of these measures with vaccine efficacy. To, furthermore, undertake an exploratory analysis of transcriptomic correlates of vaccine immunogenicity and efficacy. This may be undertaken by microarray analysis or RNA sequencing or both techniques.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Oct 2015

First posted30 Sep 2014 (estimated)
Study startJan 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Plasmodium Falciparum 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02252640
Sponsor's protocol ID: VAC059
Other IDs: 2014-001301-40, 2014
Status last verified: Dec 2015
First submitted: 25 Sep 2014
Last updated: 3 Dec 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2015. 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 and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA Encoding ME-TRAP and Also RTS,S/AS01B Alone
ClinicalTrials.gov ID: NCT02252640
Acronym / sponsor ID: VAC059
Conditions: Plasmodium Falciparum Malaria
Keywords: Plasmodium Falciparum, Malaria, Vaccine, Plasmodium, Falciparum
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: The PATH Malaria Vaccine Initiative (MVI), National Institute for Health Research, United Kingdom
Study start: Jan 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 30 Sep 2014 (estimated)
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.

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess:

The ability of the vaccines to prevent malaria infection.
The safety of the vaccines in healthy participants.
The response of the human immune system to the vaccines.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group 1	Active comparator	Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
Group 2	Active comparator	Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Biological: RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
Group 3	Active comparator	Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Biological: ChAd63 ME-TRAP (5 x 10^10 vp), Biological: MVA ME-TRAP (2 x 10^8 pfu)Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
Group 4	Active comparator	Biological: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Biological: RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01), Biological: ChAd63 ME-TRAP (5 x 10^10 vp), Biological: MVA ME-TRAP (2 x 10^8 pfu)Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01) \& MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
Group 5	No intervention	–Week 11: Controlled Human Malaria Infection
Group 6	No intervention	–Week 31-39: Controlled Human Malaria Infection

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 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.
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 and for at least 3 years after the end of their involvement in the study.

Key exclusion criteria (31 listed)

History of clinical malaria (any species).
Travel to a malaria endemic region during the study period or within the preceding six months with significant risk of malaria exposure.
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 malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data. If any volunteers in Group 1-4 undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in this trial

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
RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)	Biological	Group 1, Group 2, Group 3, Group 4
RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)	Biological	Group 2, Group 4
ChAd63 ME-TRAP (5 x 10^10 vp)	Biological	Group 3, Group 4
MVA ME-TRAP (2 x 10^8 pfu)	Biological	Group 3, Group 4

Primary outcome

Efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
Time frame: 6 months
Use statistical analysis to compare number of completely protected individuals (those who do not, by Day 23 following sporozoite challenge, develop blood stage infection measured by occurrence of P. falciparum parasitemia, assessed by blood slide)
Safety of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
Time frame: 6 months
Occurrence of solicited and unsolicited adverse events will be monitored. Solicited and unsolicited AE data will be collected at each clinic visit. It will be collected from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups.

1 secondary outcome

Immunogenicity generated in malaria naïve individuals of two different dosing regimens of RTS,S/AS01B given concomitantly with ChAd63/MVA ME-TRAP, and of RTS,S/AS01B alone at either full standard dose or with a reduced third dose.
Time frame: 6 months

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 3 Dec 2015.

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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 VS Hill principal investigator

University of Oxford

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 31 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 3 Dec 2015. 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 of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge. (time frame: 6 months). The study lists 2 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 NCT02252640.

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 3 Dec 2015.