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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

21 sites in 4 countries.

About this study

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

Conditions

COVID-19

Being tested

SARS-CoV-2 mRNA vaccine formulation 1, SARS-CoV-2 mRNA vaccine formulation 2, SARS-CoV-2 mRNA vaccine formulation 3, Placebo (0.9% normal saline)

Medical subject headings

COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• SARS-CoV-2 mRNA vaccine formulation 1Biological

  Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

• SARS-CoV-2 mRNA vaccine formulation 2Biological

  Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

• SARS-CoV-2 mRNA vaccine formulation 3Biological

  Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

• Placebo (0.9% normal saline)Biological

  Pharmaceutical form: Liquid Route of administration: Intramuscular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)

   AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

   Measured: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

2. Number of Participants With Solicited Injection Site Reactions

   Solicited reaction (SR): expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, \& swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

   Measured: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

3. Number of Participants With Solicited Systemic Reactions

   SR was an expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF \& considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia \& chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

   Measured: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

4. Number of Participants With Unsolicited Adverse Events

   An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

   Measured: Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

5. Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

   SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring \& rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.

   Measured: From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)

6. Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance

   Laboratory tests: hemoglobin (male \& female), above \& below normal white blood cell, lymphocytes, neutrophils \& eosinophils, platelet count, creatinine \& blood urea nitrogen, hyponatremia \& hypernatremia, hyperkalemia \& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test [LFT], bilirubin (normal LFT), prothrombin \& partial thromboplastin time (seconds), Urine: protein, glucose \& blood. US FDA "Toxicity Grading Scale for Healthy Adults \& Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate \& Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category \& '0'=none of participants were available for assessment for specified Group.

   Measured: From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)

7. Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1

   GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

   Measured: Day 1 (pre-vaccination)

8. Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22

   GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

   Measured: Day 22 (post-vaccination)

9. Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36

   GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

   Measured: Day 36 (post-vaccination)

10. Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22

    SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

    Measured: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

11. Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36

    SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

    Measured: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

12. Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22

    SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

    Measured: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

13. Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36

    SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

    Measured: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

14. Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22

    Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.

    Measured: Day 22 (post-vaccination)

15. Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36

    Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.

    Measured: Day 36 (post-vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Mar 2021
2. Study start12 Mar 2021
3. Primary completion27 Jun 2022
4. Study completion27 Jun 2022

Why it stopped: Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for COVID-19Studies of the same condition, open and under way.
• More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.