Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

Phase
Recruitment status
Participants
Lead sponsor
Clover Biopharmaceuticals USA, LLC
Start date
Number of sites

Summary
CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.
Short title
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
Official title
A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Clover Biopharmaceuticals USA, LLC
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine

    Timeframe: Within 7 days after vaccination

    Proportion of participants with local and systemic solicited AEs

  2. To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine

    Timeframe: Within 28 days after vaccination

    Proportion of participants with unsolicited AEs

  3. To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine

    Timeframe: Throughout the study period, from enrollment to 6 months follow up

    Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Maximum age
85 Years
Healthy volunteers
Yes

  1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
  2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
  3. Individuals willing and able to give an informed consent, prior to screening.
  4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

  1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
  2. Recurrent or un-controlled neurological disorders or seizures.
  3. Serious or unstable chronic illnesses
  4. Any history of dementia or any medical condition that moderately or severely impairs cognition
  5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Sources for eligibility

  • AMR PhoenixPhoenix, United StatesRecruiting
  • AMR Fort MyersFort Myers, United StatesRecruiting
  • AMR LexingtonLexington, United StatesRecruiting
  • AMR Kansas CityKansas City, United StatesRecruiting
  • KnoxvilleKnoxville, United StatesRecruiting
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)