Trial Outcomes & Findings for Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects (NCT NCT04671017)
NCT ID: NCT04671017
Last Updated: 2022-04-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
153 participants
Primary outcome timeframe
within 7 days after any vaccination
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
Low Dose: VLA2001
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Black
|
0 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
0 count of participants
n=4 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 9.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 count of participants
n=5 Participants
|
51 count of participants
n=7 Participants
|
46 count of participants
n=5 Participants
|
143 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
1 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
4 count of participants
n=5 Participants
|
4 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin
|
1 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
1 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
2 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
2 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latino
|
1 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
0 count of participants
n=5 Participants
|
1 count of participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White European
|
0 count of participants
n=5 Participants
|
0 count of participants
n=7 Participants
|
1 count of participants
n=5 Participants
|
1 count of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 7 days after any vaccinationOutcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Subjects with at least one Solicited Injection Site Reaction
|
35 events
|
31 events
|
36 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Injection site tenderness
|
32 events
|
23 events
|
34 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Injection site pain
|
19 events
|
21 events
|
24 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Injection site itching
|
3 events
|
3 events
|
2 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Injection site swelling
|
1 events
|
0 events
|
1 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Subjects with at least one Solicited Systemic Reactions
|
37 events
|
32 events
|
37 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Headache
|
28 events
|
17 events
|
26 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Fatigue
|
23 events
|
15 events
|
22 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Muscle pain
|
18 events
|
15 events
|
17 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Nausea/Vomiting
|
5 events
|
7 events
|
6 events
|
|
Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Fever/Body temperature
|
2 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Day 36Population: Overall Number of Participants analyzed according to Per-Protocol Analysis Set. The Per-Protocol Analysis Set includes all participants who have no major protocol deviations. Participants who received an already licensed COVID-19 vaccine outside of the study or participants who received less than 2 vaccinations will be excluded.
Outcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=49 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=50 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
|
161.1 Geometric Mean Titer
Interval 121.35 to 213.82
|
222.3 Geometric Mean Titer
Interval 171.84 to 287.67
|
530.4 Geometric Mean Titer
Interval 421.49 to 667.52
|
SECONDARY outcome
Timeframe: until Day 36Outcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Frequency of Any Unsolicited AE
Subjects with at least one unsolicited AE
|
22 events
|
17 events
|
21 events
|
|
Frequency of Any Unsolicited AE
Investigations
|
10 events
|
8 events
|
8 events
|
|
Frequency of Any Unsolicited AE
Red blood cell sedimentation rate increased
|
5 events
|
4 events
|
5 events
|
|
Frequency of Any Unsolicited AE
Aspartate aminotransferase increased
|
2 events
|
1 events
|
2 events
|
|
Frequency of Any Unsolicited AE
Blood bilirubin increased
|
2 events
|
0 events
|
2 events
|
|
Frequency of Any Unsolicited AE
Haemoglobin decreased
|
0 events
|
0 events
|
2 events
|
|
Frequency of Any Unsolicited AE
Lymphocyte count decreased
|
0 events
|
1 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Red blood cells urine
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
White blood cell count decreased
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Alanine aminotransferase increased
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Blood sodium decreased
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
C-reactive protein increased
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Neutrophil count decreased
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Prothrombin time prolonged
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Red blood cell count decreased
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
White blood cell count increased
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Infections and infestations
|
4 events
|
5 events
|
2 events
|
|
Frequency of Any Unsolicited AE
COVID-19
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Gastroenteritis
|
1 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Tooth infections
|
0 events
|
1 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Vulvovaginal candidiasis
|
0 events
|
2 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Epididymitis
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Onychomycosis
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Paronychia
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Urinary tract infections
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Blood and lymphatic system disorders
|
4 events
|
2 events
|
4 events
|
|
Frequency of Any Unsolicited AE
Neutropenia
|
2 events
|
0 events
|
3 events
|
|
Frequency of Any Unsolicited AE
Lymphopenia
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Thrombocytopenia
|
0 events
|
1 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Eosinophilia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Leukopenia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Microcytic anaemia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Neutrophilia
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Nervous system disorders
|
3 events
|
1 events
|
3 events
|
|
Frequency of Any Unsolicited AE
Headache
|
0 events
|
1 events
|
3 events
|
|
Frequency of Any Unsolicited AE
Dizziness
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Paraesthesia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Presyncope
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Respiratory, thoracic and mediastinal disorders
|
3 events
|
3 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Oropharyngeal pain
|
3 events
|
3 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Cough
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Rhinorrhoea
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Sinus congestion
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Injury, poisoning and procedural complications
|
1 events
|
2 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Vaccination complications
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Chillblains
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Ligament sprain
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Gastrointestinal disorders
|
3 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Aphthous ulcer
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Constipation
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Diarrhoea
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Gingival discomfort
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
General disorders and administration site conditions
|
1 events
|
1 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Influenza like illness
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Pain
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Peripheral swelling
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Musculoskeletal and connective tissue disorders
|
1 events
|
2 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Arthritis
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Limb discomfort
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Musculoskeletal stiffness
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Pain in extremity
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Metabolism and nutrition disorders
|
1 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Dehydration
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Increased appetite
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Renal and urinary disorders
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Haematuria
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Reproductive system and breast disorders
|
1 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Dysmenorrhoea
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Vaginal haemorrhage
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Unsolicited AE
Eye disorders
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Asthenopia
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Psychiatric disorders
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Anxiety
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Skin and subcutaneous tissue disorders
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Unsolicited AE
Rash erythematous
|
0 events
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: until Day 36Outcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Frequency of Any Vaccine-related AE
Neutropenia
|
1 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Diarrhoea
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Subjects with at least one treatment related unsolicited AE until Day 36
|
12 events
|
7 events
|
8 events
|
|
Frequency of Any Vaccine-related AE
Investigations
|
6 events
|
5 events
|
4 events
|
|
Frequency of Any Vaccine-related AE
Red blood cell sedimentation rate increased
|
5 events
|
3 events
|
3 events
|
|
Frequency of Any Vaccine-related AE
Alanine aminotransferase increased
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Blood bilirubin increased
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Lymphocyte count decreased
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
White blood cell count decreased
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Blood and lymphatic system disorders
|
2 events
|
0 events
|
2 events
|
|
Frequency of Any Vaccine-related AE
Eosinophilia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Thromocytopenia
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Nervous system disorders
|
2 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Dizziness
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Headache
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Paraesthesia
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Respiratory, thoracic and mediastinial disorders
|
2 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Oropharyngeal pain
|
2 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Musculoskeletal and connective tissue disorders
|
1 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Limb discomfort
|
0 events
|
1 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Musculoskeletal stiffness
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Gastrointestinal disorders
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
General disorders and administration site conditions
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Pain
|
1 events
|
0 events
|
0 events
|
|
Frequency of Any Vaccine-related AE
Infections and infestations
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Gastroenteritis
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Skin and subcutaneous tissue disorders
|
0 events
|
0 events
|
1 events
|
|
Frequency of Any Vaccine-related AE
Rash erythematous
|
0 events
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 36All Adverse Events of Special Interest (AESIs) were treated as important medical event and were therefore be treated as SAE according to protocol.
Outcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Frequency of Any SAE
|
0 events
|
1 events
|
0 events
|
SECONDARY outcome
Timeframe: until Day 36Outcome measures
| Measure |
Low Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 Participants
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Frequency of Any AESI
|
0 events
|
1 events
|
0 events
|
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 7 plus 6 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 10Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 10Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Day 208Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until Visit 9Outcome measures
Outcome data not reported
Adverse Events
Low Dose: VLA2001
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Medium Dose: VLA2001
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
High Dose: VLA2001
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
0.00%
0/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
Other adverse events
| Measure |
Low Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
Medium Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
High Dose: VLA2001
n=51 participants at risk
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
|
|---|---|---|---|
|
Investigations
Red blood cell sedimentation rate increased
|
9.8%
5/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
7.8%
4/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
9.8%
5/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.9%
2/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
0.00%
0/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
5.9%
3/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
2.0%
1/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
5.9%
3/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
3/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
5.9%
3/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
2.0%
1/51 • Adverse event data was collected from the date of first vaccination until the second part of the study, where participants were followed up on Day 106 (Visit 5) and will be followed up further until Day 208/Month 7 (Visit 6), 6 months after the second vaccination.
The number of participants here represent the number of healthy adults recruited in 3 dose groups (low, medium and high). Adverse event information was collected at specified time points up to the cut-off date for Day 106 (Visit 5) analysis of 30 June 2021.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place