Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (VAW00001)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798027
Recruitment Status : Active, not recruiting
First Posted : March 15, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objectives of the study are:

  • To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose.
  • To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.

The secondary objectives of the study are:

  • To describe binding antibody profile from Day 1 to Day 387 of each study intervention group.
  • To describe the neutralizing antibody profile from Day 90 to Day 387 of each study intervention group.
  • To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed SARS-CoV-2 infection.
  • To evaluate the correlation/association between antibody responses to SARS-CoV-2 mRNA vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SARS-CoV-2 mRNA vaccine formulation 1 Biological: SARS-CoV-2 mRNA vaccine formulation 2 Biological: SARS-CoV-2 mRNA vaccine formulation 3 Biological: Placebo (0.9% normal saline) Phase 1 Phase 2

Detailed Description:
The duration of each participant's participation in the study will be approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a sequential group prevention study consisting of a sentinel cohort followed by the Full Enrollment Cohort. There will be 3 dose levels (up to 25 participants 18-49 years of age for each dose level) in the Sentinel Cohort, which will be done in an open-label fashion with stepwise safety evaluation for each dose level and each vaccination. All sentinel participants will receive 2 vaccinations, 21 days apart. For the Full Enrollment Cohort, participants will be stratified into 2 age groups based on age at enrollment: the younger adult age group (140 participants 18-49 years of age) and the older adult age group (168 participants ≥ 50 years of age). The Full Enrollment Cohort 1 (Groups 1 to 4) will receive a single injection of study intervention while participants in Cohort 2 (Groups 5 to 8) will receive 2 vaccinations (to be given 21 days apart).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

In the Full Enrollment Cohort: blinding for vaccine group assignment (formulation) of participants, outcome assessors, Investigators, laboratory personnel, and Sponsor study staff. Only study site staff who prepare and administer the vaccine and are not involved with the safety evaluations will be unblinded to vaccine group assignment. There will be no blinding for injection schedule.

The Sentinel Cohort is open-label (no blinding).

Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : November 2, 2022
Estimated Study Completion Date : November 2, 2022

Arm Intervention/treatment
Experimental: Group 1
1 injection of SARS-CoV-2 mRNA vaccine formulation 1 at Day 1
Biological: SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Experimental: Group 2
1 injection of SARS-CoV-2 mRNA vaccine formulation 2 at Day 1
Biological: SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Experimental: Group 3
1 injection of SARS-CoV-2 mRNA vaccine formulation 3 at Day 1
Biological: SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Placebo Comparator: Group 4
1 injection of placebo at Day 1
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection

Experimental: Group 5
2 injections of SARS-CoV-2 mRNA vaccine formulation 1 at Day 1 and Day 22
Biological: SARS-CoV-2 mRNA vaccine formulation 1
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Experimental: Group 6
2 injections of SARS-CoV-2 mRNA vaccine formulation 2 at Day 1 and Day 22
Biological: SARS-CoV-2 mRNA vaccine formulation 2
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Experimental: Group 7
2 injections of SARS-CoV-2 mRNA vaccine formulation 3 at Day 1 and Day 22
Biological: SARS-CoV-2 mRNA vaccine formulation 3
Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

Placebo Comparator: Group 8
2 injections of placebo at Day 1 and Day 22
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: Liquid Route of administration: Intramuscular injection




Primary Outcome Measures :
  1. Presence of immediate adverse events [ Time Frame: Within 30 minutes after vaccination ]
    Immediate adverse events include unsolicited systemic adverse events occurring within 30 minutes after vaccination

  2. Presence of solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills.

  3. Presence of unsolicited adverse events [ Time Frame: Within 21 days after vaccination ]
    Adverse events other than solicited reactions.

  4. Presence of medically attended adverse events [ Time Frame: From Day 1 to Day 387 ]
    A medically attended adverse event is a new-onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department

  5. Presence of serious adverse events (SAE) and adverse events of special interest (AESI) [ Time Frame: From Day 1 to Day 387 ]
    SAEs are collected throughout the study.

  6. Presence of out-of-range biological test results [ Time Frame: From Day 1 up to 8 days post-last injection ]
    Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test) are considered. The assessment include white blood cell count, hemoglobin, platelet count, clinical chemistry parameters, and coagulation parameters.

  7. Neutralizing antibody titer [ Time Frame: From Day 1 to Day 36 ]
    Neutralizing antibody titers expressed as geometric mean titers.

  8. Fold-rise in neutralizing antibody titer [ Time Frame: From Day 1 to Day 36 ]
    Fold-rise in serum neutralization titer post-vaccination relative to Day 1

  9. 2-fold and 4-fold rise in neutralizing antibody titer [ Time Frame: From Day 1 to Day 36 ]
    Fold-rise relative to Day 1.

  10. Occurrence of neutralizing antibody seroconversion [ Time Frame: From Day 1 to Day 36 ]
    Seroconversion is defined as baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ post-vaccination


Secondary Outcome Measures :
  1. Binding antibody concentration [ Time Frame: From Day 1 to Day 387 ]
  2. Binding antibody concentration ratio [ Time Frame: From Day 1 to Day 387 ]
    Fold-rise in binding antibody concentration postvaccination relative to Day 1

  3. Fold-rise in binding antibody concentration (post/pre) ≥ 2 and ≥ 4 [ Time Frame: From Day 1 to Day 387 ]
  4. Neutralizing antibody titers at Day 91 to Day 387 [ Time Frame: From Day 91 to Day 387 ]
  5. Fold-rise in neutralizing antibody titer at Day 91 to Day 387 [ Time Frame: From Day 91 to Day 387 ]
    Fold-rise in serum neutralization titer post-vaccination relative to Day 1

  6. 2-fold and 4-fold rise in neutralizing antibody titer at Day 91 to Day 387 [ Time Frame: From Day 91 to Day 387 ]
  7. Occurrence of neutralizing antibody seroconversion at Day 91 to Day 387 [ Time Frame: From Day 91 to Day 387 ]
    Seroconversion is defined as baseline values below LLOQ with detectable neutralization titer above assay LLOQ post-vaccination

  8. Occurrences of virologically-confirmed COVID-19-like illness [ Time Frame: From Day 1 to Day 387 ]
    Virologically-confirmed COVID-19-like illness is defined as a positive result for SARS CoV-2 by Nucleic Acid Amplification Test (NAAT) on a respiratory sample in association with a COVID-19-like illness

  9. Occurrences of serologically-confirmed SARS-CoV-2 infection [ Time Frame: From Day 1 to Day 387 ]
    Serologically-confirmed COVID-19-like illness is defined as a positive result in serum for the presence of antibodies specific to SARS-CoV-2 detected by immunoassay

  10. Correlates of risk/protection based on antibody responses to SARS-CoV-2 [ Time Frame: From Day 1 to Day 387 ]
    Correlate analysis considering virologically-confirmed COVID-19-like illness and/or serologically confirmed SARS CoV 2 infection



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

Inclusion criteria :

  • Aged ≥ 18 years on the day of inclusion.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.

OR

  • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination.

A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention.

  • Informed Consent Form has been signed and dated.
  • Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.

Exclusion criteria:

  • History of COVID-19 disease or prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed serologically.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
  • Known liver disease or fatty liver.
  • Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment.
  • Receipt of immuneglobulins, blood or blood-derived products in the past 3 months.
  • Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus [MERS-CoV]).
  • Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which may be received at least 2 weeks before and a minimum of 2 weeks after study vaccines.
  • Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36.
  • Residence in a nursing home or long-term care facility.
  • Health care workers providing direct patient care for COVID-19 patients.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT04798027


Locations
Show Show 21 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04798027    
Other Study ID Numbers: VAW00001
U1111-1251-5486 ( Registry Identifier: ICTRP )
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 18, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs