Phase 2
N=153
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
SARS-CoV-2 Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04671017 ↗Enrolled (actual)
153
Serious AEs
0.7%
Results posted
Mar 2022
Primary outcome: Primary: Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series — 35; 31; 36; 32 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VLA2001 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series |
35; 31; 36; 32; 23; 34 | — |
| PRIMARY Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay |
161.1; 222.3; 530.4 | — |
| SECONDARY Frequency of Any Unsolicited AE |
22; 17; 21; 10; 8; 8 | — |
| SECONDARY Frequency of Any Vaccine-related AE |
12; 7; 8; 6; 5; 4 | — |
| SECONDARY Frequency and Severity of Any AE |
— | — |
| SECONDARY Frequency and Severity of Any Vaccine-related AE |
— | — |
| SECONDARY Frequency of Any SAE |
0; 1; 0 | — |
| SECONDARY Frequency of Any AESI |
0; 1; 0 | — |
| SECONDARY Frequency and Severity of Any SAE |
— | — |
| SECONDARY Frequency and Severity of an AESI |
— | — |
| SECONDARY Frequency and Severy of Solicited AEs (Local and Systemic Reactions) After the Booster Vaccination |
— | — |
| SECONDARY Frequency and Severity of Any Unsolicited AE |
— | — |
| SECONDARY Frequency and Severity of Any Vaccine-related AE |
— | — |
| SECONDARY Frequency and Severity of Any SAE |
— | — |
| SECONDARY Frequency and Severity of Any AESI |
— | — |
| SECONDARY Immune Response as Measured by Neutralizing Antibody Titres Against SARS-CoV-2 |
— | — |
| SECONDARY Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies |
— | — |
| SECONDARY Fold Increase of SARS-CoV-2 Neutralizing Antibody Titres Compared With Baseline |
— | — |
| SECONDARY GMTs for IgG Antibodies Against SARS-CoV-2 Determined by ELISA |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 2 Weeks After Booster Dose With Regards to Neutralizing Antibodies |
— | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Pre-booster Time Point (Visit 7) to 4 Weeks After Booster Dose With Regards to Neutralizing Antibodies |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Geometric Mean Titres (GMT) Measured as Neutralizing Antibody Titres Against SARSCoV-2 |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY Geometric Mean Titres (GMT) Measured as IgG Antibodies Against SARS-CoV-2 (ELISA |
— | — |
Summary
A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.
Eligibility Criteria
Inclusion Criteria - Subjects who meet ALL of the following criteria are eligible for the study:
- Participant is 18 to 55 years of age
- Participant who has a smart phone and is willing and able to install and use the eDiary.
- Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
- Participant is generally healthy as determined by the Investigator
- Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
- If subject is of childbearing potential:
- Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0).
- Participant has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively.
- Participant agrees to employ adequate birth control measures up to Day 106 (Visit 5).
Inclusion Criteria for Booster Phase - Subjects who meet ALL of the following criteria are eligible for the Booster phase:
- B1. Participant has received complete VLA2001 primary immunization (two vaccinations according to the protocol)
- B2. Participant who has a smart phone and is willing and able to install and use the e-Diary.
- B3. Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
- B4. Participant is generally healthy as determined by the Investigator's clinical judgement
- B5. If a participant is of childbearing potential:
- Participant has a negative urine pregnancy test at Visit 7 prior to booster vaccination.
- Participant agrees to employ adequate birth control measures up to 3 months after the Booster vaccination.
Exclusion criteria - Participants who meet ANY of the following criteria are NOT eligible for this study:
- Clinically significant infection or other acute illness, including fever ≥ 38°C within 24 hours prior to the planned study vaccination.
- History of laboratory-confirmed SARS-CoV-2 infection.
- Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0).
- Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
- Participant has an acute or recent infection not due to SARS-CoV-2
- Participant has a history of SARS-CoV-1 or MERS infection (self-reported)
- Participant tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Participant has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination.
- Participant has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.
- Participants with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator's clinical judgement.
- Participants with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected
- Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site.
- Participant has a known or suspected defect of the immune system, such as Participants with congenital or acquired immune deficiency
- Participant received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
- Part
Data sourced from ClinicalTrials.gov (NCT04671017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.