Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04864561
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
This is a multicentre, randomized, observer-blind, active-controlled, superiority, study in adults to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT of SARS-CoV-2-specific neutralising antibodies. Furthermore, VLA2001 will be compared to placebo in an adolescent population.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Virus Infection Biological: VLA2001 Biological: AZD1222 Biological: VLA2001 - adolescent part Biological: Placebo Phase 3

Detailed Description:

Approximately 4000 Adult 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=2000) 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.

Approximately 660 Adolescent participants will be recruited and randomized in a 1:1 ratio to receive 2 intramuscular doses of either VLA2001 (n=330) or placebo (n=300). Adolescents randomized to receive VLA2001, will receive a booster vaccination with VLA2001 at Day 208. Participants in the placebo group will receive a 2-dose primary immunization with VLA2001 at day 208 and the second vaccination 28 days later. For safety reasons, the first 16 adolescents will be enrolled in an open label, non-randomized manner (sentinel dosing).

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4679 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, study participant aged 12-18 and 30 years above at the time of enrolment are blinded (sentinel group is unblinded) until 28 days after vaccination on day 208, when all participants will be 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 Including a Randomized, Observer-blind, Placebo Controlled Part in Adolescents (≥12 to <18 Years)
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 16, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

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 phospho-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 AZD1222 is a recombinant, replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 S surface glycoprotein.

Active Comparator: VLA2001 - adolescent part
≥12 to < 18 years will be randomized 1:1 to receive VLA2001 or Placebo
Biological: VLA2001 - adolescent part
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxid 2 vaccinations 28 days apart and with a booster vaccination on day 208. Placebo group will receive VLA2001 on day 208 and following second vaccination 28 days later.

Placebo Comparator: Placebo
≥12 to < 18 years will be randomized 1:1 to receive VLA2001 or Placebo
Biological: Placebo
2 vaccinations 28 days apart with placebo (PBS buffer based on Dulbecco's PBS media formulation without Calcium and Magnesium )




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. Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies [ Time Frame: Day 43 ]
  3. Frequency and severity of any Adverse Events (AE) [ Time Frame: Up to Day 43 post-vaccination ]

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. ]
    Seroconversion is defined as >= 4-fold increase in SARS-CoV-2 neutralizing antibody titer and S-protein binding IgG levels between Day 1 and post-vaccination timepoints

  2. Immune response as determined by the geometric mean titer (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 geometric mean titer (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 (Th1/Th2 polarization) from PBMCs in a subset of participants after in vitro stimulation with SARS-CoV-2 antibodies using, e.g. ELISpot ir intracellular cytokine staining [ Time Frame: on Day 1, Day 8, Day 29, Day 43, Day 71, Day 208 and Day 365 ]
  5. Frequency and severity of solcited injection site and systemic reactions [ Time Frame: within 7 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 unsolicited vaccine-related Adverse Events (AE) [ Time Frame: until Day 43 ]
  9. Frequency and severity of any Serious Adverse Event (SAE) [ Time Frame: until Month 12 ]
  10. Frequency and severity of any Adverse Event Of Special Interest (AESI) [ Time Frame: until Month 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, 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 12 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.

Booster Vaccination (Adolescents)

In addition to the above described eligibility criteria, the following criteria must be met:

- Participant has completed the primary vaccination schedule per protocol (i.e. has received 2 study vaccinations within protocol windows).


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


Contacts
Layout table for location contacts
Contact: Valneva Clinical Development +43 1 206 20 ext 0 office@valneva.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Layout table for investigator information
Study Chair: Valneva Clinical Development Valneva Austria GmbH
Layout table for additonal information
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: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
COVID-19
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases