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Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

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: NCT04537208
Recruitment Status : Active, not recruiting
First Posted : September 3, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objectives of the study are:

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

The secondary objectives of the study are:

  • To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group.
  • To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group.
  • To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
COVID-19 (Healthy Volunteers) Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 1 Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 2 Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 1 Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 2 Biological: SARS-CoV-2 vaccine formulation 2 without adjuvant 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a parallel group prevention study. Participants from 2 age groups (adults 18 through 49 years of age and adults 50 years of age and older) will receive either 1 injection (Cohort 1) or 2 injections (Cohort 2) of study vaccine or placebo control.

As a precautionary step, a sentinel safety cohort of 6 participants (younger adults only) within each dosing group from Cohort 1 will be enrolled. An early safety data review will be performed, including evaluation of safety data and laboratory measures to Day 9. Upon acceptable safety demonstrated from unblinded data review by limited members of the Sponsor Study Team, the remaining participants will be enrolled simultaneously.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, outcome assessors, Investigators, laboratory personnel, and the majority of Sponsor study staff will be blinded to vaccine group assignment; injection schedule will be unblinded and those preparing/administering the study interventions will be unblinded.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Group 1 (18 - 49 years of age)
1 injection of SARS-CoV-2 vaccine formulation 1 with adjuvant 1 at Day 1
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 2 (18 - 49 years of age)
1 injection of SARS-CoV-2 vaccine formulation 1 with adjuvant 2 at Day 1
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 3 (18 - 49 years of age)
1 injection of SARS-CoV-2 vaccine formulation 2 with adjuvant 1 at Day 1
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 4 (18 - 49 years of age)
1 injection of SARS-CoV-2 vaccine formulation 2 with adjuvant 2 at Day 1
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Placebo Comparator: Group 5 (18 - 49 years of age)
1 injection of placebo at Day 1
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 6 (18 - 49 years of age)
2 injections of SARS-CoV-2 vaccine formulation 1 with adjuvant 1 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 7 (18 - 49 years of age)
2 injection of SARS-CoV-2 vaccine formulation 1 with adjuvant 2 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 8 (18 - 49 years of age)
2 injections of SARS-CoV-2 vaccine formulation 2 with adjuvant 1 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 9 (18 - 49 years of age)
2 injections of SARS-CoV-2 vaccine formulation 2 with adjuvant 2 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 10 (18 - 49 years of age)
2 injections of SARS-CoV-2 vaccine formulation 2 without adjuvant at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 2 without adjuvant
Pharmaceutical form: liquid; route of administration: intramuscular injection

Placebo Comparator: Group 11 (18 - 49 years of age)
2 injections of placebo at Day 1 and Day 22
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 1 (50 years of age and older)
1 injection of SARS-CoV-2 vaccine formulation 1 with adjuvant 1 at Day 1
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 2 (50 years of age and older)
1 injection of SARS-CoV-2 vaccine formulation 1 with adjuvant 2 at Day 1
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 3 (50 years of age and older)
1 injection of SARS-CoV-2 vaccine formulation 2 with adjuvant 1 at Day 1
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 4 (50 years of age and older)
1 injection of SARS-CoV-2 vaccine formulation 2 with adjuvant 2 at Day 1
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Placebo Comparator: Group 5 (50 years of age and older)
1 injection of placebo at Day 1
Biological: Placebo (0.9% normal saline)
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 6 (50 years of age and older)
2 injections of SARS-CoV-2 vaccine formulation 1 with adjuvant 1 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 7 (50 years of age and older)
2 injections of SARS-CoV-2 vaccine formulation 1 with adjuvant 2 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 1 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 8 (50 years of age and older)
2 injections of SARS-CoV-2 vaccine formulation 2 with adjuvant 1 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 1
Pharmaceutical form: liquid; route of administration: intramuscular injection

Experimental: Group 9 (50 years of age and older)
2 injections of SARS-CoV-2 vaccine formulation 2 with adjuvant 2 at Day 1 and Day 22
Biological: SARS-CoV-2 vaccine formulation 2 with adjuvant 2
Pharmaceutical form: liquid; route of administration: intramuscular injection

Placebo Comparator: Group 11 (50 years of age and older)
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. Neutralizing Antibody Titer at Day 1 [ Time Frame: Day 1 ]
    Neutralizing antibody titer expressed as geometric mean titer.

  2. Neutralizing Antibody Titer at Day 22 [ Time Frame: Day 22 ]
    Neutralizing antibody titer expressed as geometric mean titer.

  3. Neutralizing Antibody Titer at Day 36 [ Time Frame: Day 36 ]
    Neutralizing antibody titer expressed as geometric mean titer.

  4. Fold-rise of Neutralizing Antibody Titer at Day 22 [ Time Frame: Day 22 ]
    Fold rise in antibody neutralization titer post-vaccination relative to Day 1.

  5. Fold-rise of Neutralizing Antibody Titer at Day 36 [ Time Frame: Day 36 ]
    Fold rise in antibody neutralization titer post-vaccination relative to Day 1.

  6. 2-fold and 4-fold Rise in Neutralization Antibody titer at Day 22 [ Time Frame: Day 22 ]
    Rise in antibody neutralizing titer (post/pre) relative to Day 1.

  7. 2-fold and 4-fold Rise in Neutralization Antibody titer at Day 36 [ Time Frame: Day 36 ]
    Rise in antibody neutralizing titer (post/pre) relative to Day 1.

  8. Percentage of Participants with Neutralizing Antibody Seroconversion at Day 22 [ Time Frame: Day 22 ]
    Percentage of participants with baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ.

  9. Percentage of Participants with Neutralizing Antibody Seroconversion at Day 36 [ Time Frame: Day 36 ]
    Percentage of participants with baseline values below LLOQ with detectable neutralization titer above assay LLOQ.

  10. Number of Participants with Immediate Adverse Events [ Time Frame: Within 30 minutes after vaccination ]
    Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination.

  11. Number of Participants With Solicited Injection Site or Systemic Reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise and myalgia.

  12. Number of Participants with Unsolicited Adverse Events [ Time Frame: Within 21 days after vaccination ]
    Adverse events other than solicited reactions.

  13. Number of Participants with Medically Attended Adverse Events [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    Medically attended adverse events are adverse events with 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.

  14. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    SAEs are collected throughout the study.

  15. Number of Participants with Adverse Events of Special Interest [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.

  16. Number of Participants with Out-of-range Biological Test Results [ Time Frame: From Day 1 up to 7 days post-last injection ]

Secondary Outcome Measures :
  1. Binding Antibody Concentration [ Time Frame: Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) ]
    Antibody titers are expressed as geometric mean concentration.

  2. Binding Antibody Concentration Ratio [ Time Frame: Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) ]
    Fold rise in concentration relative to Day 1.

  3. Fold Rise in Binding Antibody Concentration [ Time Frame: Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) ]
    ≥ 2 and ≥ 4 fold rise in concentration post/pre-vaccination.

  4. Neutralizing Antibody Titer [ Time Frame: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) ]
    Neutralizing antibody titer expressed as geometric mean titer.

  5. Fold-rise in Neutralization Titer at Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) [ Time Frame: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) ]
    Fold rise in antibody neutralization titer post-vaccination relative to Day 1.

  6. 2-fold and 4-fold Rise in Neutralization Titer [Post/Pre] at Day 181 and 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) [ Time Frame: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) ]
    Fold rise in antibody neutralization titer post-vaccination relative to Day 1.

  7. Percentage of Participants with Neutralizing Antibody Seroconversion at Day 181 and 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) [ Time Frame: Day 181 and Day 366 (Cohort 1) and Day 202 and Day 387 (Cohort 2) ]
    Neutralizing antibody seroconversion is defined as values below LLOQ at baseline with detectable neutralization titer above assay LLOQ at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) or Day 387 (Cohort 2)

  8. Number of Participants with Virologically-confirmed COVID-19-like Illness [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    Virologically-confirmed COVID-19-like illness is defined by specified clinical symptoms and signs and confirmed by nucleic acid viral detection assay. Illness surveillance is performed by active surveillance from Day 1 to Day 181 in Cohort 1 and from Day 1 to Day 202 in Cohort 2, and by passive surveillance during the remainder of the study period.

  9. Number of Participants with Serologically-confirmed SARS-CoV-2 Infection [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    Serologically-confirmed SARS-CoV-2 infection is defined by SARS-CoV-2-specific antibody detection. Illness surveillance is performed by active surveillance from Day 1 to Day 181 in Cohort 1 and from Day 1 to Day 202 in Cohort 2, and by passive surveillance during the remainder of the study period.

  10. Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2 [ Time Frame: From Day 1 up to the end of study (Day 366 for Cohort 1 and Day 387 for Cohort 2) ]
    Correlate of risk / protection is based on antibody responses to SARS-CoV-2, considering cases of virologically-confirmed COVID-19 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.


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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:

  • Aged 18 years of age or older on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile
  • 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
  • Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome)
  • 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)
  • History of SARS-CoV-2 infection, confirmed either clinically, serologically, or microbiologically
  • 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
  • Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw
  • 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): NCT04537208


Locations
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United States, Alabama
Investigational Site Number 8400004
Birmingham, Alabama, United States, 35294
United States, California
Investigational Site Number 8400012
Rolling Hills Estates, California, United States, 90274
United States, Florida
Investigational Site Number 8400011
Hollywood, Florida, United States, 33024
Investigational Site Number 8400019
Melbourne, Florida, United States, 32934
United States, Massachusetts
Investigational Site Number 8400016
Boston, Massachusetts, United States, 02115
United States, Nebraska
Investigational Site Number 8400002
Omaha, Nebraska, United States, 68134
United States, New York
Investigational Site Number 8400001
Rochester, New York, United States, 14609
Investigational Site Number 8400007
Rochester, New York, United States, 14642
United States, Ohio
Investigational Site Number 8400008
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Investigational Site Number 8400003
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Investigational Site Number 8400014
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
GlaxoSmithKline
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04537208    
Other Study ID Numbers: VAT00001
U1111-1250-4757 ( Other Identifier: UTN )
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs