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Thursday, 11/26/2020 2:41:04 PM

Thursday, November 26, 2020 2:41:04 PM

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Ino-4800 P2: US-measures-B-KillerT-cell-response. China-measures-same-and-B-cell-durability-640-ppl
Humoral immunity is named so because it involves substances found in the humors, or body fluids. It contrasts with cell-mediated immunity. Humoral immunity can also be referred to as antibody-mediated immunity.

B cells are responsible for humoral immunity. Helper T cells aid the development of B cells into plasma cells. It is plasma cells that produce and secrete immunoglobulins iG, or antibodies.

Humoral immunity secretes antibodies to fight against antigens, whereas cell-mediated immunity secretes cytokines and no antibodies to attack the pathogens. The Humoral immunity is rapid or quick in their action against antigens, while the Cell-mediated immunity (by Killer T cells) show delay though permanent action against any pathogens.

https://clinicaltrials.gov/ct2/show/NCT04642638?term=Ino-4800&draw=2&rank=3

Primary Outcome Measures :
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-?) Enzyme-linked Immunospot (ELISpot) Assay [ Time Frame: Baseline up to Day 393 ]
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
Phase 3: Percentage of Participants With Virologically-confirmed COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]

Primary objectives: ? To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old); ? To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Secondary objective: ? To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Exploratory objective: ? To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old).

http://www.chictr.org.cn/showprojen.aspx?proj=64452
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