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Moderna COVID-19 Vaccine, mRNA-1273

Phase 3

Immunocompromised Patients | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: Jan 25, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment610
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04805125Immunocompromised Swiss Cohorts Based Trial PlatformPHASE3 COMPLETED 610Apr 19, 2021Sep 23, 2023Jan 25, 20244 Switzerland
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Study Endpoints
Primary Endpoints
immunological outcome: change in pan-Ig antibody response (pan-Ig anti-S1-RBD)
at baseline (day of vaccination) and three months after vaccination

A commercial immunoassay Elecsys® Anti-SARS-CoV-2 S for the in vitro quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum and plasma is used. This assay detects pan-Ig antibody response (pan-Ig anti-S1-RBD) and allows for a quantitative assessment of the serological response of the participants.

immunological outcome: change in anti-Nucleocapsid (N) response
at baseline (day of vaccination) and three months after vaccination

Qualitative measurement of anti-Nucleocapsid (N) responses with Elecsys® Anti-SARS-CoV-2 N assay

immunological outcome: change in SARS-CoV-2-binding antibodies
at baseline (day of vaccination) and three months after vaccination

SARS-CoV-2-binding antibody responses of the participants are assessed by analyzing the IgM, IgA and IgG responses to a wider range of SARS-CoV-2 proteins (S1, S2, RBD and N) using an in-house method (ABCORA). The ABCORA test allows a parallel assessment of IgG, IgM and IgA reactivity.

Number of participants with newly polymerase chain reaction (PCR)-confirmed asymptomatic COVID-19 infection
at any time point in within 48 weeks following randomisation (day of vaccination)

Number of participants with newly PCR-confirmed asymptomatic COVID-19 infection (identified by the presence of anti-SARS-CoV-2 nucleocapsid antibodies or Sars-Cov-2 PCR or rapid antigen test) and no related symptoms \[(i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea\])

Number of participants with newly PCR-confirmed symptomatic COVID-19 infection
at any time point in within 48 weeks following randomisation (day of vaccination)

Number of participants with newly PCR-confirmed symptomatic COVID-19 infection with at least one of the following symptoms (i.e. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose nausea or vomiting, and diarrhea

Number of participants with severe COVID-19 infection
at any time point in within 48 weeks following randomisation (day of vaccination)

Number of participants with severe COVID-19 infection with respiratory failure, evidence of shock (as diagnosed by a treating physician), clinically significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death

Clinical Outcome: COVID-19 burden of diseases (BOD)
within 48 weeks following randomisation (day of vaccination)

COVID-19 burden of diseases (BOD), a composite, will be scored as by using 0 for no COVID-19, 1 for non-severe COVID-19, and 2 for severe COVID-19.

Duration of RCT set up (specific endpoint related to trial conduct feasibility)
one time assessment at baseline (from deciding which interventions will be tested until the first patient is randomised)

Duration of RCT set up (i.e. time from deciding which interventions will be tested until the first patient is randomised).

Time of patient recruitment from activation of first study site until 40 patients are randomised
one time assessment after approx. 3 months (from activation of first study site until 40 patients are randomised)
Time of patient recruitment from activation of first study site until 380 patients are randomised
one time assessment after approx. 3 months (from activation of first study site until 380 patients are randomised)
Patient consent rate
approx. 3 months

Patient consent rate (i.e. proportion of patients giving informed consent out of approached eligible patients)

Proportion of missing data for all baseline variables from routinely collected cohort data
one time assessment at baseline
Proportion of missing data for all clinical outcomes
one time assessment after approx. 3 months

Proportion of missing data for all clinical outcomes from routinely collected cohort data and outcome data that is collected in the trial platform

SARS-CoV-2-specific antibodies
three months after vaccination

SARS-CoV-2-specific antibodies (using a pan-IgG antibody assay against the receptor binding domain (RBD) against the nP and spike 1 subunits)

SARS-CoV-2-specific titers
three months after vaccination

SARS-CoV-2-specific titers (using an in-house assay developed by the Institute of Medical Virology, University of Zurich which can detect multiple viral epitopes)

The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed in the observational second sub- protocol
8 weeks (¨+/- 2 weeks) after 3. vaccination

The proportion of patients with a positive antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain in human serum or plasma assessed or plasma assessed in the observational second sub- protocol by the commercial immunoassay Elecsys Anti-SARS-CoV-2 S (Elecsys S) from Roche Diagnostics. An antibody response will be considered as positive using the threshold ≥ 100 units/ml, predicting a protective immune response.

Secondary Endpoints
The proportion of patients with a positive antibody response using SARS-CoV-2 spike (S1) Elecsys S by Roche in the observational second sub- protocol, using a threshold of ≥0.8 units/ml as defined by the manufacturer
8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with a positive antibody response using antibody response using the Antibody CORonavirus Assay (ABCORA) 2 in the observational second sub- protocol
8 weeks (¨+/- 2 weeks) after 3. vaccination
The proportion of patients with neutralizing neutralization activity against the vaccine strain Wuhan-Hu-1 in the observational second sub- protocol
8 weeks (¨+/- 2 weeks) after 3. vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Moderna mRNA COVID-19 vaccineACTIVE_COMPARATORThe Moderna COVID-19 Vaccine, mRNA-1273 (100 μg) is administered intramuscularly as a series of two doses (0.5 mL each), given 28 days apart. ARM CLOSED
Comirnaty® (Pfizer / BioNTech) mRNA COVID-19 vaccineACTIVE_COMPARATORActive: The comparator product is the first licensed vaccine against SARS-CoV-2 in Switzerland. Pfizer-BioNTech COVID-19 Vaccine, BNT162b2 (30 µg) Comirnaty®, is administered intramuscularly (IM) as a series of two 30 µg doses of the diluted vaccine solution (0.3 mL each) according to the following schedule: a single dose followed by a second dose 21 days later. ARM CLOSED
Interventions
NameTypeDescription
Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)BIOLOGICALintramuscular injection, proposed as a series of two doses (0.5 mL each), dosing is 100 microgram on day 0 and day 28
Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)BIOLOGICALintramuscular injection, proposed dosing is 30 microgram of the diluted vaccine solution (0.3 mL each) on day 0 and day 21
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: * All patients registered with informed consent from participating cohorts aged ≥18 years * Additional consent for participation in the specific sub-protocol trial Inclusion criteria for pilot trial: * All patients with either a chronic HIV infection or recipients of solid org...

Countries:Switzerland
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