Advanced Non-small Cell Lung CancerPhase 1NCT03371485
AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer
A Phase 1 study testing AST-VAC2 in people with Advanced Non-small Cell Lung Cancer, run by Cancer Research UK at 2 sites in United Kingdom.
Trial summary
This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- AST-VAC2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 May 2018to 8 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a) Patients with advanced NSCLC (metastatic or locally advanced), for whom there are no other suitable treatment options.-
- Able to and likely to be well enough to receive six vaccinations i.e. judged by the Investigator to not require alternate treatment for the duration of the vaccination schedule and period to end of vaccination visit.
- Has had sufficient wash out periods from previous treatments as follows:
- four weeks for chemotherapy ii) six weeks for investigational medicinal products (IMPs) iii) eight weeks for immunotherapy (shorter intervals may be acceptable based on half-life of treatment. Eligibility will be confirmed by the Sponsor and CI).
- Measurable disease
- Biopsiable disease is preferable however patients without biopsiable disease can still be considered for the study.
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- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- Confirmed HLA A*02:01 positive genotype.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-2.
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed prior to the patient receiving the first AST-VAC2 vaccination.
- Laboratory Test and Value required
- Haemoglobin (Hb) ≥9.0 g/dL; Absolute neutrophil count (ANC) ≥1.5 x 10^9 /L; Platelet count ≥100 x 10 ^9/L; Lymphocyte count ≥1.0 x 10^9 /L; Bilirubin ≤1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3.0 x ULN; Calculated creatinine clearance > 30 mL/min
- 18 years or over at the time consent is given.
Who cannot join
- Radiotherapy (except for palliative reasons) during the previous four weeks before treatment.
- Ongoing toxic manifestations of previous treatments greater than CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
- Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial with the exception of replacement treatment. Inhaled and topical steroids are permitted. The predictable need of their use will preclude the patient from trial entry.
- Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence*, effective from the first administration of AST-VAC2 throughout the trial and for six months afterwards are considered eligible.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence* effective from the first administration of AST-VAC2, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
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- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Evidence of any ongoing active autoimmune disease.
- Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I trial of AST-VAC2. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.
- Any vaccination given within four weeks before the first AST-VAC2 vaccination (except for COVID-19 vaccinations which are permitted at investigators discretion).
- Any planned prophylactic vaccination from trial entry until completion of the AST-VAC2 vaccinations (except for COVID-19 vaccinations which are permitted at investigators discretion).
- Any condition which might interfere with the patient's ability to generate an immune response.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Elizabeth Hospital
Birmingham
Southampton General Hospital
Southampton
About this study
Official title: A Cancer Research UK Phase I Trial of AST-VAC2 (Allogeneic Dendritic Cell Vaccine) Administered Weekly Via Intradermal Injection in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to AST-VAC2 inside the body.
Read the detailed description
This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laboratory studies but it has never been tested in man.
Dendritic cells occur naturally in your body as part of the immune system however these dendritic cells have a special role in finding proteins in the body which are associated with cancer and it is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer.
Some cancers tend to have more of a certain type of protein (part of the body's building blocks that make up cells) called 'hTERT' and it has been shown in laboratory studies (and also studies in patients using a similar type of vaccine), that targeting hTERT can lead to destruction of cancer cells by the immune system. AST-VAC2 will target the hTERT protein.
Human Leukocyte Antigen (HLA) is another type of protein. An HLA pre-screening test will be able to show if a person is positive or negative for a specific HLA protein (AST-VAC2 can only work with some types of HLA), as being positive for the protein may mean there is a better chance of the vaccine attacking the cancer. Patients who are positive for the specific HLA type will be asked to consent to the vaccine. Those patients who are negative for the HLA type will not be eligible for the trial.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- AST-VAC2
- Keywords
- Non-small cell lung cancer, Immunotherapy, Cancer vaccine, Dendritic cell vaccine, Allogeneic vaccine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-VAC2Biological
Allogeneic dendritic cell vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Participants with advanced NSCLC, to receive AST-VAC2 | Experimental | Participants will receive up to a maximum of six vaccinations over six weeks. Each weekly AST-VAC2 vaccination will be administered as a split dose via two intradermal injections at a target dose defined as 1 x 10^7 viable cells. There is no dose escalation planned during the study; only one dose level will be explored. Receives: Biological: AST-VAC2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2
Number of SAEs, NSAEs and Grade ≥3 AEs overall and number of SAEs, NSAEs and Grade ≥3 AEs related to AST-VAC2. AEs categorised according to Medical Dictionary for Regulatory Activities (MedDRA) version (v) 25.0 and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.02 or protocol specific grading system for injection site reactions (ISRs; Section 9.8 of protocol). AEs assessed by the reporting study doctors for a causal relationship to AST-VAC2. Related are those AEs with a causality of possible, probable or highly probable. All AEs and SAEs were collected until 30 days post last vaccination but only related AEs and SAEs were collected thereafter.
Measured: From the time of informed consent up to 2 years from the first dose of AST-VAC2, a median (range) of 402.5 days (101-770).
Number of Participants Experiencing ISRs by Grade
Number of participants experiencing ISRs Grade 1 to 4 according to protocol-specific grading of ISRs (protocol section 9.8); Grade 1: minimal effect on activities of daily living, Grade 2: restricts activities of daily living, Grade 3: prevents/severely limits activities of daily living, Grade 4: life-threatening consequences; urgent intervention indicated. Participants may have had ISRs of different grades at different vaccinations and are counted once for each grade of ISR reported.
Measured: From the time of informed consent up to 2 years from the first dose of AST-VAC2, a median (range) of 402.5 days (101-770).
Secondary outcomes (6)
Number of Participants Showing a Durable Peripheral Immune Response
Immunological response in whole blood (peripheral blood mononuclear cells) by human telomerase reverse transcriptase (hTERT) specific T cells measured by enzyme-linked immunospot (ELISPOT), with a durable peripheral immune response defined as a change in one validated assay at two time points after at least two vaccinations (where a change is defined as 2.5 fold change over baseline [after removal of background], assay control and >35 spots/10^6 cells).
Measured: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 1 Assay (p1-387)
Immunological response in whole blood (peripheral blood mononuclear cells) by hTERT specific T cells measured by ELISPOT and presented as mean fold change in spots/10^6 cells (after removal of background) from baseline to each timepoint assessed. Mean (full range) data are reportable data from the participants analysed at each timepoint. Non-reportable data and timepoints where no participants had reportable data are not shown.
Measured: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763)
Immunological response in whole blood (peripheral blood mononuclear cells) by hTERT specific T cells measured by ELISPOT and presented as mean fold change in spots/10^6 cells (after removal of background) from baseline to each timepoint assessed. Mean (full range) data are reportable data from the participants analysed at each timepoint. Non-reportable data and timepoints where no participants had reportable data are not shown.
Measured: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132)
Immunological response in whole blood (peripheral blood mononuclear cells) by hTERT specific T cells measured by ELISPOT and presented as mean fold change in spots/10^6 cells (after removal of background) from baseline to each timepoint assessed. Mean (full range) data are reportable data from the participants analysed at each timepoint. Non-reportable data and timepoints where no participants had reportable data are not shown.
Measured: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Tumour Response According to Immune-Related Response Criteria (irRC) Post Vaccination
Number of participants with complete response, partial response, stable disease, progressive disease or who were not evaluable at radiological disease assessment (computerised tomography and/or magnetic resonance imaging) at the End of Vaccination visit according to irRC (Appendix 3 of protocol).
Measured: Radiological disease assessment at Baseline and End of Vaccination visit (30 days post last vaccination), up to 94 days.
Overall Survival at 2 Years Post First Vaccination
Number of participants alive at 2 years post their first vaccination.
Measured: From first AST-VAC2 vaccination to 2 years post first vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start29 May 2018
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Middleton, Prof, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371485
- Sponsor's protocol ID
- CRUKD/17/003
- Other IDs
- 2016-002577-35, 2016
- Status last verified
- Mar 2024
- First submitted
- 29 Sep 2017
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cancer Research UK Phase I Trial of AST-VAC2 (Allogeneic Dendritic Cell Vaccine) Administered Weekly Via Intradermal Injection in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03371485
- Acronym / sponsor ID
- CRUKD/17/003
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Immunotherapy, Cancer vaccine, Dendritic cell vaccine, Allogeneic vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to AST-VAC2 inside the body.
Detailed description
This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laboratory studies but it has never been tested in man.
Dendritic cells occur naturally in your body as part of the immune system however these dendritic cells have a special role in finding proteins in the body which are associated with cancer and it is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer.
Some cancers tend to have more of a certain type of protein (part of the body's building blocks that make up cells) called 'hTERT' and it has been shown in laboratory studies (and also studies in patients using a similar type of vaccine), that targeting hTERT can lead to destruction of cancer cells by the immune system. AST-VAC2 will target the hTERT protein.
Human Leukocyte Antigen (HLA) is another type of protein. An HLA pre-screening test will be able to show if a person is positive or negative for a specific HLA protein (AST-VAC2 can only work with some types of HLA), as being positive for the protein may mean there is a better chance of the vaccine attacking the cancer. Patients who are positive for the specific HLA type will be asked to consent to the vaccine. Those patients who are negative for the HLA type will not be eligible for the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with advanced NSCLC, to receive AST-VAC2 | Experimental | Biological: AST-VAC2Participants will receive up to a maximum of six vaccinations over six weeks. Each weekly AST-VAC2 vaccination will be administered as a split dose via two intradermal injections at a target dose defined as 1 x 10^7 viable cells. There is no dose escalation planned during the study; only one dose level will be explored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- a) Patients with advanced NSCLC (metastatic or locally advanced), for whom there are no other suitable treatment options.-
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- Confirmed HLA A*02:01 positive genotype.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-2.
Key exclusion criteria (16 listed)
- Radiotherapy (except for palliative reasons) during the previous four weeks before treatment.
- Ongoing toxic manifestations of previous treatments greater than CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
- Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial with the exception of replacement treatment. Inhaled and topical steroids are permitted. The predictable need of their use will preclude the patient from trial entry.
- Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence*, effective from the first administration of AST-VAC2 throughout the trial and for six months afterwards are considered eligible.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence* effective from the first administration of AST-VAC2, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
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 |
|---|---|---|
| AST-VAC2Allogeneic dendritic cell vaccine. | Biological | Participants with advanced NSCLC, to receive AST-VAC2 |
Primary outcome
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2
Time frame: From the time of informed consent up to 2 years from the first dose of AST-VAC2, a median (range) of 402.5 days (101-770).
Number of SAEs, NSAEs and Grade ≥3 AEs overall and number of SAEs, NSAEs and Grade ≥3 AEs related to AST-VAC2. AEs categorised according to Medical Dictionary for Regulatory Activities (MedDRA) version (v) 25.0 and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.02 or protocol specific grading system for injection site reactions (ISRs; Section 9.8 of protocol). AEs assessed by the reporting study doctors for a causal relationship to AST-VAC2. Related are those AEs with a causality of possible, probable or highly probable. All AEs and SAEs were collected until 30 days post last vaccination but only related AEs and SAEs were collected thereafter.
Number of Participants Experiencing ISRs by Grade
Time frame: From the time of informed consent up to 2 years from the first dose of AST-VAC2, a median (range) of 402.5 days (101-770).
Number of participants experiencing ISRs Grade 1 to 4 according to protocol-specific grading of ISRs (protocol section 9.8); Grade 1: minimal effect on activities of daily living, Grade 2: restricts activities of daily living, Grade 3: prevents/severely limits activities of daily living, Grade 4: life-threatening consequences; urgent intervention indicated. Participants may have had ISRs of different grades at different vaccinations and are counted once for each grade of ISR reported.
6 secondary outcomes
Number of Participants Showing a Durable Peripheral Immune Response
Time frame: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 1 Assay (p1-387)
Time frame: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763)
Time frame: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132)
Time frame: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.
Tumour Response According to Immune-Related Response Criteria (irRC) Post Vaccination
Time frame: Radiological disease assessment at Baseline and End of Vaccination visit (30 days post last vaccination), up to 94 days.
Overall Survival at 2 Years Post First Vaccination
Time frame: From first AST-VAC2 vaccination to 2 years post first vaccination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Simple summary of trial on Cancer Research UK website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gary Middleton, Prof principal investigator
The Queen Elizabeth Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AST-VAC2 in people with Advanced Non-small Cell Lung Cancer, run by Cancer Research UK 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 14 inclusion and 16 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 9 Aug 2024. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 (time frame: From the time of informed consent up to 2 years from the first dose of AST-VAC2, a median (range) of 402.5 days (101-770).). 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?
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 9 Aug 2024.