Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study
건강한 성인에서 AS03 보조제 SARS-CoV-2 재조합 단백질 백신(CoV2 preS dTM)의 안전성 및 면역원성: 2상, 무작위, 용량 찾기, 다기관 연구의 중간 결과
Clinical Trial
Published on
Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단,
Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단,
[키워드] 95% CI
abstinence
adjuvants
Adults
adverse event
adverse events
Adverse reaction
Adverse reactions
age
All participant
All participants
antibody
Antibody titre
Antigen
AS03
assessments
assigned
authority
baseline
booster vaccination
candidate vaccine
Chemotherapy
childbearing potential
clinical development
Clinical research
clinical trial
Cohort
Contraception
COVID-19 vaccine
D614G variant
development
dose
effective
Endpoint
enrolled
evaluated
expected
fixed
Frequency
geometric mean
geometric mean titre
GMT
GMT ratio
GMTs
groups
healthy
High dose
High-dose
high-dose group
Immunocompromised
immunogenicity
increase in
increased risk
injection
injection site
Injections
intensity
interim results
investigator
investigators
involved
Laboratory
lactating
low dose
low-dose
medical condition
Medical conditions
medium
medium dose
Mild
mild to moderate
moderate
multicentre
Neutralising Antibodies
neutralising antibody
neutralising antibody titre
neutralising antibody titres
occurred
Older
Older adults
Organ transplant
outcome
outcome assessor
outcome assessors
parallel-group
participant
Participants
Phase 2
Phase 3
positive
prefusion
pregnant
primary immunogenicity
progression
proportion
Protein
protocol
provided
pseudovirus neutralisation assay
randomised
Randomly
reactogenicity
receive
Registered
reported
Research
research and development
responses
robust
Safety
safety analysis
safety endpoints
safety profile
Sanofi Pasteur
SARS-CoV-2
second dose
second vaccination
selected
Serious Adverse Event
Serious Adverse Events
serodiagnostic
Seven
severe COVID-19
Stratification
study period
supported
systemic
test result
titre
titres
Treatment
treatment group
treatment groups
Trial
USA
vaccination
Vaccine
was done
were excluded
were measured
yes or no
[DOI] 10.1016/S1473-3099(21)00764-7 PMC 바로가기 [Article Type] Clinical Trial
[DOI] 10.1016/S1473-3099(21)00764-7 PMC 바로가기 [Article Type] Clinical Trial