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Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE)

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ClinicalTrials.gov Identifier: NCT04864561
Recruitment Status : Active, not recruiting
First Posted : April 29, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:

This is a multicentre, randomized, observer-blind, active-controlled, superiority, study to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT.

Approximately 4000 participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis.


Condition or disease Intervention/treatment Phase
Sars-Cov-2 Virus Infection Biological: VLA2001 Biological: AZD1222 Phase 3

Detailed Description:

This is a multicentre, randomized, observer-blind, active-controlled, superiority, study to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT.

Approximately 4000 participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of either VLA2001 (n=3000) or AZD1222 (n=1000). In addition, approximately 1000 subjects aged 18-29 years will participate in this study in a non-randomized, open-label fashion to receive VLA2001. The 2 doses of vaccination for both vaccines will be administered 28 days apart, on Days 1 and 29. All visits will be conducted at the clinical site on an outpatient basis.

Immunogenicity (neutralizing antibody titers) and safety will be assessed up to months 12 after the first vaccination.

Participants will be provided with an electronic Diary (e-Diary) and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4019 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: study participants aged 18-29 years at the time of enrolment are unblinded
Primary Purpose: Prevention
Official Title: A Randomized, Observer-Blind, Controlled, Superiority Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine, In Adults
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Active Comparator: VLA2001
<30 years will receive VLA2001; participants aged >=30 years will be randomised 2:1 to receive VLA2001 or AZD1222
Biological: VLA2001

whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phosphor-guanine (CpG) 1018 in combination with aluminium hydroxide

2 vaccinations 28 days apart


Active Comparator: AZD1222
<30 years will receive VLA2001; participants aged >=30 years will be randomised 2:1 to receive VLA2001 or AZD1222
Biological: AZD1222
2 vaccinations 28 days apart




Primary Outcome Measures :
  1. Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]
  2. Frequency and severity of any Adverse Events (AE) [ Time Frame: Up to Day 43 ]

Secondary Outcome Measures :
  1. Proportion of participants with seroconversion [ Time Frame: on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365. ]
  2. Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies. [ Time Frame: on Day 8 (age 55+ only), Day 29, Day 71, Day 208 and Day 365 ]
  3. Immune response as determined by the GMT of IgG antibodies to SARS-CoV-2 S-protein. [ Time Frame: on Day 8 (age 55+ only), Day 29, Day 43, Day 71, Day 208 and Day 365 ]
  4. Assessment of T-cell responses on selected time points in a subset of participants [ Time Frame: on Day 1, Day 29, Day 43, Day 71, Day 208 and Day 365 ]
  5. Frequency and severity of solicited injection site and systemic reactions [ Time Frame: seven days after each and after any vaccination. ]
  6. Frequency and severity of any Adverse Events (AE) [ Time Frame: until Month 12 ]
  7. Frequency and severity of any unsolicited Adverse Events (AE) [ Time Frame: until Day 43 ]
  8. Frequency and severity of any Serious Adverse Event (SAE) [ Time Frame: until Month 12 ]
  9. Frequency and severity of any adverse event of special interest (AESI) [ Time Frame: until Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants must have read, understood, and signed the informed consent form (ICF).
  2. Participants of either gender aged 18 years and older at screening.
  3. Medically stable
  4. Must be able to attend all visits of the study and comply with all study procedures,
  5. Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine.
  6. WOCBPs must have a negative pregnancy test prior to each vaccination.

Exclusion Criteria:

  1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration.
  2. History of allergy to any component of the vaccine.
  3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever > 100 °F (> 37.8 °C) 48 hours before vaccination.
  4. Participant has a known or suspected defect of the immune system
  5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
  6. 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 participant 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.
  7. History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
  8. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1).
  9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
  10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition.
  11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer

    Prior/concomitant therapy:

  12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study.
  13. Receipt of medications and or vaccinations intended to prevent COVID-19.
  14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1).
  15. Any member of the study team or sponsor.
  16. An immediate family member or household member of the study's personnel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864561


Locations
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Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Chair: Valneva Clinical Development Valneva Austria GmbH
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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04864561    
Other Study ID Numbers: VLA2001-301
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valneva Austria GmbH:
VLA2001
Sars-Cov-2 Virus Infection
Covid-19
inactivated-adjuvanted Sars-Cov-2 virus vaccine
Additional relevant MeSH terms:
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Virus Diseases