Trial Outcomes & Findings for AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer (NCT NCT03371485)

Last Updated: 2024-08-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

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).

Results posted on

2024-08-09

Participant Flow

Trial participants were enrolled at two trial sites between 29 May 2018 and 04 February 2022.

Participant milestones

Participant milestones
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Main Trial (6 AST-VAC2 Vaccinations) STARTED	9
Main Trial (6 AST-VAC2 Vaccinations) COMPLETED	8
Main Trial (6 AST-VAC2 Vaccinations) NOT COMPLETED	1
2-year Follow-up STARTED	8
2-year Follow-up COMPLETED	3
2-year Follow-up NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Main Trial (6 AST-VAC2 Vaccinations) Participant died before receiving AST-VAC2.	1
2-year Follow-up Death	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=9 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Age, Continuous	56 years n=9 Participants
Sex: Female, Male Female	7 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=9 Participants
Region of Enrollment United Kingdom	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 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).

Population: Safety Population: All enrolled participants who received at least one AST-VAC2 vaccination. This population will also be used for overall survival at 2 years post first AST-VAC2 vaccination. Participants are evaluable for survival regardless of whether they go on to receive another anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Total SAEs	0 Adverse Events
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Total NSAEs	97 Adverse Events
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Grade ≥3 AEs	3 Adverse Events
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Related SAEs	0 Adverse Events
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Related NSAEs	59 Adverse Events
Frequency and Causality of Serious Adverse Events (SAEs), Non-Serious Adverse Events (NSAEs) and Grade ≥3 Adverse Events (AEs) to AST-VAC2 Related Grade ≥3 AEs	1 Adverse Events

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Number of Participants Experiencing ISRs by Grade Total Grade 1 ISRs	8 Participants
Number of Participants Experiencing ISRs by Grade Total Grade 2 ISRs	2 Participants
Number of Participants Experiencing ISRs by Grade Total Grade 3 ISRs	0 Participants
Number of Participants Experiencing ISRs by Grade Total Grade 4 ISRs	0 Participants

SECONDARY outcome

Timeframe: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.

Population: Secondary Immunogenicity Endpoint Population: All eligible participants who received at least 3 AST-VAC2 vaccinations and had baseline and at least 2 post-vaccination blood samples taken.

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).

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Number of Participants Showing a Durable Peripheral Immune Response	2 Participants

SECONDARY outcome

Timeframe: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.

Population: Secondary Immunogenicity Endpoint Population: All eligible participants who received at least 3 AST-VAC2 vaccinations and had baseline and at least 2 post-vaccination blood samples taken (N=8). Some participants did not have data at all timepoints.

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.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 1 Assay (p1-387) Week 3 Vaccination	29.54 Fold Change from Baseline Interval 29.54 to 29.54
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 1 Assay (p1-387) 3 months post first vaccination	29.75 Fold Change from Baseline Interval 29.75 to 29.75

SECONDARY outcome

Timeframe: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) Week 3 Vaccination	156.89 Fold Change from Baseline Interval 30.1 to 283.67
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) Week 4 Vaccination	118.78 Fold Change from Baseline Interval 32.55 to 205.0
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) Week 6 Vaccination	47.90 Fold Change from Baseline Interval 47.9 to 47.9
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) 2 weeks post last vaccination	269.00 Fold Change from Baseline Interval 269.0 to 269.0
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) 3 months post first vaccination	331.67 Fold Change from Baseline Interval 331.67 to 331.67
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) 6 months post first vaccination	331.00 Fold Change from Baseline Interval 331.0 to 331.0
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 2 Assay (p377-763) 12 months post first vaccination	72.60 Fold Change from Baseline Interval 72.6 to 72.6

SECONDARY outcome

Timeframe: Screening, vaccination weeks 3, 4 and 6; 2 weeks post last vaccination and 3, 6 and 12 months post first vaccination.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) Week 3 Vaccination	43.79 Fold Change from Baseline Interval 43.79 to 43.79
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) Week 4 Vaccination	285.10 Fold Change from Baseline Interval 32.11 to 538.0
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) Week 6 Vaccination	515.34 Fold Change from Baseline Interval 34.68 to 996.0
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) 2 weeks post last vaccination	42.53 Fold Change from Baseline Interval 42.53 to 42.53
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) 3 months post first vaccination	45.68 Fold Change from Baseline Interval 45.68 to 45.68
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) 6 months post first vaccination	49.11 Fold Change from Baseline Interval 49.11 to 49.11
Mean Fold Change in hTERT Specific T Cells Over Baseline by Timepoint: hTERT Peptide Pool 3 Assay (p753-1132) 12 months post first vaccination	88.20 Fold Change from Baseline Interval 88.2 to 88.2

SECONDARY outcome

Timeframe: Radiological disease assessment at Baseline and End of Vaccination visit (30 days post last vaccination), up to 94 days.

Population: Response Population: All eligible participants who have received at least one AST-VAC2 vaccination and have had a baseline assessment of disease and at least one repeat disease assessment measured according to irRC. For details of irRC, refer to Appendix 3 of the study protocol. Participants with rapid tumour progression before completion of 6 AST-VAC2 vaccinations were classified as early progression and included in the Response Population.

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).

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Tumour Response According to Immune-Related Response Criteria (irRC) Post Vaccination Progressive disease (irPD)	3 Participants
Tumour Response According to Immune-Related Response Criteria (irRC) Post Vaccination Stable disease (irSD)	5 Participants

SECONDARY outcome

Timeframe: From first AST-VAC2 vaccination to 2 years post first vaccination.

Number of participants alive at 2 years post their first vaccination.

Outcome measures

Outcome measures
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 Participants 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Overall Survival at 2 Years Post First Vaccination Alive	3 Participants
Overall Survival at 2 Years Post First Vaccination Deceased	5 Participants

Adverse Events

Participants With Advanced NSCLC, to Receive AST-VAC2

Serious events: 0 serious events

Other events: 8 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Advanced NSCLC, to Receive AST-VAC2 n=8 participants at risk 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. AST-VAC2: Allogeneic dendritic cell vaccine.
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	37.5% 3/8 • Number of events 4 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Axillary pain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Bone Pain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 2/8 • Number of events 2 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Metabolism and nutrition disorders Decreased appetite	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Gastrointestinal disorders Dyspepsia	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Fatigue	75.0% 6/8 • Number of events 10 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Nervous system disorders Headache	12.5% 1/8 • Number of events 4 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Vascular disorders Hot flush	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Metabolism and nutrition disorders Hypercalcaemia	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Influenza like illness	25.0% 2/8 • Number of events 2 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Immune system disorders Infusion related hypersensitivity reaction	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Injection site reaction	100.0% 8/8 • Number of events 41 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Injury, poisoning and procedural complications Muscle strain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	25.0% 2/8 • Number of events 2 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 2/8 • Number of events 2 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Skin and subcutaneous tissue disorders Nail disorder	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Non-cardiac chest pain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Musculoskeletal and connective tissue disorders Plantar fasciitis	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Skin and subcutaneous tissue disorders Psoriasis	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Gastrointestinal disorders Rectal haemorrhage	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Swelling	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
General disorders Vaccination site pain	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.
Respiratory, thoracic and mediastinal disorders Wheezing	12.5% 1/8 • Number of events 1 • Safety data were collected from the time of informed consent until 2 years from the first dose of AST-VAC2 for this interim report. Participants were to be followed-up for 5 years and any changes to information reported at end of trial updated. However, no participants continued beyond 2 years and end of trial was reached. Median (range) time from informed consent to end of follow-up was 402.5 days (101-770). AEs and SAEs collected until 30 days post last vaccination; only related AEs and SAEs collected thereafter. AE terms from vocabulary MedDRA v25.0. Reported for the Safety Population: all enrolled participants who received at least one AST-VAC2 vaccination (N=8). All-cause mortality reported for all participants (N=9), including those who died prior to receiving AST-VAC2 (n=1) or during survival follow-up for reasons unrelated to AST-VAC2 (n=5) and that were not part of the safety analyses.

Additional Information

Regulatory Affairs Manager

Cancer Research UK Centre for Drug Development

Phone: +44 203 4696878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place