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Intramuscular VaccineWiki

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drug2907 nCapp, a cell phone-based auto-diagnosis system Wiki 1.00

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D018352 Coronavirus Infections NIH 0.04

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There is one clinical trial.

Clinical Trials

1 A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age

The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of six months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.

NCT04450004 SARS-CoV 2 Biological: Intramuscular Vaccine
MeSH:Coronavirus Infections

Primary Outcomes

Description: Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs)

Measure: Immediate adverse event (AEs)

Time: 30 minutes

Description: Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination

Measure: Solicited local and systemic adverse events (AEs)

Time: 7 days

Description: Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration

Measure: Unsolicited adverse events (AEs)

Time: 21 days

Description: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration

Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths

Time: 21 days

Description: Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.

Measure: Safety labs

Time: 3 days

Description: Nab response induced by the vaccine against the SARS-CoV-2 virus

Measure: Neutralizing antibody (Nab assay) response

Time: 21 days

Description: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot)

Measure: Specific Th1 cell-mediated immunity (CMI) response

Time: 21 days

Description: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot

Measure: Specific Th2 cell-mediated immunity (CMI) response

Time: 21 days

Secondary Outcomes

Description: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths from 22 days after the last vaccination up to the end of the study

Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths

Time: Day 42 to 201

Description: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus, as measured by total IgG and/or IgM levels

Measure: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus measured by total IgG and/or IgM levels

Time: Day 21, 42 and 201

Description: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus

Measure: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus

Time: Day 201

Description: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IFN- γ ELISpot

Measure: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus

Time: Day 201

Description: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IL-4 ELISpot.

Measure: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus

Time: Day 201

Other Outcomes

Description: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by the percentage of CD4+ T cells expressing functional markers

Measure: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus

Time: Day 21 and 201

Description: Specific antibody response induced by the vaccine against plant glycans as measured by serum IgE levels directed against Cross-reactive Carbohydrate Determinants (CCD) MUXF3 using bromelain glycoprotein

Measure: Specific antibody response induced by the vaccine against plant glycans

Time: Day 21 and 201

Description: If deemed necessary, further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine

Measure: Further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine

Time: Day 21, 42, 201

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