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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

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ClinicalTrials.gov Identifier: NCT04671017
Recruitment Status : Completed
First Posted : December 17, 2020
Results First Posted : March 24, 2022
Last Update Posted : April 22, 2022
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition SARS-CoV-2 Virus Infection
Intervention Biological: VLA2001
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Period Title: Overall Study
Started 51 51 51
Completed 51 51 51
Not Completed 0 0 0
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001 Total
Hide Arm/Group Description VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide Total of all reporting groups
Overall Number of Baseline Participants 51 51 51 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 51 participants 153 participants
33.7  (8.89) 35.5  (9.53) 31.3  (8.52) 33.5  (9.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 51 participants 153 participants
Female 24 17 29 70
Male 27 34 22 83
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Count of participants
Number Analyzed 51 participants 51 participants 51 participants 153 participants
White 46 51 46 143
Black 0 0 0 0
Asian 1 0 0 1
Mixed 0 0 4 4
Latin 1 0 0 1
Latin American 2 0 0 2
Latino 1 0 0 1
White European 0 0 1 1
1.Primary Outcome
Title Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series
Hide Description [Not Specified]
Time Frame within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 51 51
Measure Type: Number
Unit of Measure: events
Subjects with at least one Solicited Injection Site Reaction 35 31 36
Injection site tenderness 32 23 34
Injection site pain 19 21 24
Injection site itching 3 3 2
Injection site swelling 1 0 1
Subjects with at least one Solicited Systemic Reactions 37 32 37
Headache 28 17 26
Fatigue 23 15 22
Muscle pain 18 15 17
Nausea/Vomiting 5 7 6
Fever/Body temperature 2 0 0
2.Primary Outcome
Title Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay
Hide Description [Not Specified]
Time Frame Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 49 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric Mean Titer
161.1
(121.35 to 213.82)
222.3
(171.84 to 287.67)
530.4
(421.49 to 667.52)
3.Secondary Outcome
Title Frequency of Any Unsolicited AE
Hide Description [Not Specified]
Time Frame until Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 51 51
Measure Type: Number
Unit of Measure: events
Subjects with at least one unsolicited AE 22 17 21
Investigations 10 8 8
Red blood cell sedimentation rate increased 5 4 5
Aspartate aminotransferase increased 2 1 2
Blood bilirubin increased 2 0 2
Haemoglobin decreased 0 0 2
Lymphocyte count decreased 0 1 1
Red blood cells urine 1 1 0
White blood cell count decreased 1 1 0
Alanine aminotransferase increased 0 0 1
Blood sodium decreased 1 0 0
C-reactive protein increased 1 0 0
Neutrophil count decreased 1 0 0
Prothrombin time prolonged 1 0 0
Red blood cell count decreased 0 0 1
White blood cell count increased 0 1 0
Infections and infestations 4 5 2
COVID-19 1 1 0
Gastroenteritis 1 0 1
Tooth infections 0 1 1
Vulvovaginal candidiasis 0 2 0
Epididymitis 0 1 0
Onychomycosis 1 0 0
Paronychia 0 1 0
Urinary tract infections 1 0 0
Blood and lymphatic system disorders 4 2 4
Neutropenia 2 0 3
Lymphopenia 1 1 0
Thrombocytopenia 0 1 1
Eosinophilia 1 0 0
Leukopenia 1 0 0
Microcytic anaemia 1 0 0
Neutrophilia 0 1 0
Nervous system disorders 3 1 3
Headache 0 1 3
Dizziness 1 0 0
Paraesthesia 1 0 0
Presyncope 1 0 0
Respiratory, thoracic and mediastinal disorders 3 3 1
Oropharyngeal pain 3 3 1
Cough 1 0 0
Rhinorrhoea 0 1 0
Sinus congestion 1 0 0
Injury, poisoning and procedural complications 1 2 1
Vaccination complications 1 1 0
Chillblains 0 1 0
Ligament sprain 0 0 1
Gastrointestinal disorders 3 0 0
Aphthous ulcer 1 0 0
Constipation 1 0 0
Diarrhoea 1 0 0
Gingival discomfort 1 0 0
General disorders and administration site conditions 1 1 1
Influenza like illness 0 0 1
Pain 1 0 0
Peripheral swelling 0 1 0
Musculoskeletal and connective tissue disorders 1 2 0
Arthritis 0 1 0
Limb discomfort 0 1 0
Musculoskeletal stiffness 1 0 0
Pain in extremity 1 0 0
Metabolism and nutrition disorders 1 0 1
Dehydration 0 0 1
Increased appetite 1 0 0
Renal and urinary disorders 1 1 0
Haematuria 1 1 0
Reproductive system and breast disorders 1 0 1
Dysmenorrhoea 0 0 1
Vaginal haemorrhage 1 0 0
Eye disorders 0 0 1
Asthenopia 0 0 1
Psychiatric disorders 0 0 1
Anxiety 0 0 1
Skin and subcutaneous tissue disorders 0 0 1
Rash erythematous 0 0 1
4.Secondary Outcome
Title Frequency of Any Vaccine-related AE
Hide Description [Not Specified]
Time Frame until Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 51 51
Measure Type: Number
Unit of Measure: events
Subjects with at least one treatment related unsolicited AE until Day 36 12 7 8
Investigations 6 5 4
Red blood cell sedimentation rate increased 5 3 3
Alanine aminotransferase increased 0 0 1
Blood bilirubin increased 1 0 0
Lymphocyte count decreased 0 1 0
White blood cell count decreased 0 1 0
Blood and lymphatic system disorders 2 0 2
Neutropenia 1 0 1
Eosinophilia 1 0 0
Thromocytopenia 0 0 1
Nervous system disorders 2 0 1
Dizziness 1 0 0
Headache 0 0 1
Paraesthesia 1 0 0
Respiratory, thoracic and mediastinial disorders 2 1 0
Oropharyngeal pain 2 1 0
Musculoskeletal and connective tissue disorders 1 1 0
Limb discomfort 0 1 0
Musculoskeletal stiffness 1 0 0
Gastrointestinal disorders 1 0 0
Diarrhoea 1 0 0
General disorders and administration site conditions 1 0 0
Pain 1 0 0
Infections and infestations 0 0 1
Gastroenteritis 0 0 1
Skin and subcutaneous tissue disorders 0 0 1
Rash erythematous 0 0 1
5.Secondary Outcome
Title Frequency and Severity of Any AE
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Frequency and Severity of Any Vaccine-related AE
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Frequency of Any SAE
Hide Description All Adverse Events of Special Interest (AESIs) were treated as important medical event and were therefore be treated as SAE according to protocol.
Time Frame until Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 51 51
Measure Type: Number
Unit of Measure: events
0 1 0
8.Secondary Outcome
Title Frequency of Any AESI
Hide Description [Not Specified]
Time Frame until Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description:
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
Overall Number of Participants Analyzed 51 51 51
Measure Type: Number
Unit of Measure: events
0 1 0
9.Secondary Outcome
Title Frequency and Severity of Any SAE
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Frequency and Severity of an AESI
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination
Hide Description [Not Specified]
Time Frame until Visit 7 plus 6 days
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Frequency and Severity of Any Unsolicited AE
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Frequency and Severity of Any Vaccine-related AE
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Frequency and Severity of Any SAE
Hide Description [Not Specified]
Time Frame until Visit 10
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Frequency and Severity of Any AESI
Hide Description [Not Specified]
Time Frame until Visit 10
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
19.Secondary Outcome
Title GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Proportion of Participants With Seroconversion in Terms of IgG Antibodies Against SARS-CoV-2, as Determined by ELISA in Participants Negative for SARS-CoV-2 at Screening
Hide Description [Not Specified]
Time Frame until Day 208
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Hide Description [Not Specified]
Time Frame until Visit 8
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Hide Description [Not Specified]
Time Frame until Visit 8
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Hide Description [Not Specified]
Time Frame until Visit 8
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to S-protein Binding Antibodies (ELISA)
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Hide Description [Not Specified]
Time Frame until Visit 8
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Proportion of Participants With 4-fold Increase From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose in Regards to S-protein Binding Antibodies (ELISA)
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA
Hide Description [Not Specified]
Time Frame until Visit 9
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Hide Arm/Group Description VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide VLA2001 whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in comibinationn with aluminium hydroxide
All-Cause Mortality
Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/51 (0.00%)      0/51 (0.00%)    
Hide Serious Adverse Events
Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      1/51 (1.96%)      0/51 (0.00%)    
Injury, poisoning and procedural complications       
Chillblains *  0/51 (0.00%)  0 1/51 (1.96%)  1 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose: VLA2001 Medium Dose: VLA2001 High Dose: VLA2001
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/51 (15.69%)      6/51 (11.76%)      12/51 (23.53%)    
Blood and lymphatic system disorders       
Neutropenia *  2/51 (3.92%)  0/51 (0.00%)  3/51 (5.88%) 
Investigations       
Red blood cell sedimentation rate increased *  5/51 (9.80%)  4/51 (7.84%)  5/51 (9.80%) 
Nervous system disorders       
Headache   0/51 (0.00%)  1/51 (1.96%)  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain *  3/51 (5.88%)  3/51 (5.88%)  1/51 (1.96%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Strategy Manager
Organization: Valneva Austria GmbH
Phone: +43 1 206 20 ext 0
EMail: office@valneva.com
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04671017    
Other Study ID Numbers: VLA2001-201
First Submitted: December 15, 2020
First Posted: December 17, 2020
Results First Submitted: March 7, 2022
Results First Posted: March 24, 2022
Last Update Posted: April 22, 2022