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MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcgWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1648 MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg Wiki 1.00
drug1650 MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg Wiki 1.00
drug2413 Remdesivir Wiki 0.23
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dosage-Escalation, Single Centre Study to Evaluate the Safety and Immunogenicity of an Adjuvanted SARS-CoV-2 Sclamp Protein Subunit Vaccine in Healthy Adults Aged 18 to 55 Years Old.

This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

NCT04495933 SARS-CoV2 Covid19 Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg Other: Placebo

Primary Outcomes

Description: - the frequency of solicited local reactogenicity adverse events (AEs)

Measure: Frequency of Solicited local reactogenicity adverse events (AEs)

Time: 7 days following each vaccination (at Days 1 and 29)

Description: - the frequency of solicited systemic reactogenicity AEs

Measure: Frequency of Solicited systemic reactogenicity adverse events (AEs)

Time: 7 days following each vaccination (at Days 1 and 29)

Description: - the grading of solicited local reactogenicity adverse events (AEs)

Measure: Grading of Solicited local reactogenicity adverse events (AEs)

Time: 7 days following each vaccination (at Days 1 and 29)

Description: - the grading of solicited systemic reactogenicity AEs

Measure: Grading of Solicited systemic reactogenicity adverse events (AEs)

Time: 7 days following each vaccination (at Days 1 and 29)

Description: - the frequency, duration, intensity and relationship to vaccination of unsolicited local adverse events (AEs)

Measure: Unsolicited adverse events (AEs)

Time: 28 days following each vaccination (at Days 1 and 29)

Description: - the frequency, duration, intensity and relationship to vaccination of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study (including decision by the Principal Investigator [PI] not to proceed with the second dose) at any time during the study

Measure: Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study

Time: through study completion (394 days)

Description: - Geometric mean titre (GMT) of the serum antibody response compared to placebo

Measure: Geometric Mean Titer (GMT) of the serum antibody response

Time: 28 days following each vaccination (Days 29 and 57)

Description: GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo

Measure: Geometric Mean Titer (GMT) of the serum neutralizing antibody (NAb) response to SARS-CoV-2 virus

Time: 28 days following each vaccination (Days 29 and 57)

Secondary Outcomes

Description: GMT of the serum antibody response compared to placebo

Measure: Total serum antibody immune responses

Time: through study completion (394 days)

Description: proportion of participants with greater than or equal to 4 fold increase in titre above baseline compared to placebo.

Measure: proportion of participants with ≥ 4 fold increase in titer above baseline

Time: through study completion (394 days)

Description: GMT of the serum neutralizing antibody (NAb) immune responses compared to placebo

Measure: GMT of the serum neutralizing antibody (NAb) titres

Time: through study completion (394 days)

No related HPO nodes (Using clinical trials)