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RecruitingNCT06843317Updated May 14, 2025

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

A Phase 1 interventional study of Candidate vaccine, SCB-1019T and AREXVY in RSV Infection, sponsored by Clover Biopharmaceuticals USA, LLC. Recruiting at 5 sites in United States. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Clover Biopharmaceuticals USA, LLC · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

02

Conditions studied

  • RSV Infection
03

In context

Respiratory Syncytial Virus Infections

302 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 48 are open to participants now.

This study's planned enrollment of 160 is above the median of 89 across 219 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

This is the only study on the registry with Clover Biopharmaceuticals USA, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  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.

Exclusion criteria

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Group 1 (SCB-1019T)

    50 adults to receive low dose SCB-1019T at Day 1

    Biological: Candidate vaccine, SCB-1019T

  • Experimental
    Group 2 (SCB-1019T)

    50 adults to receive high dose SCB-1019T at Day 1

    Biological: Candidate vaccine, SCB-1019T

  • Active comparator
    Group 3 (AREXVY)

    50 adults to receive AREXVY at Day 1

    Biological: AREXVY

  • Placebo comparator
    Group 4 (Placebo)

    10 adults to receive Placebo at Day 1

    Other: placebo

Interventions

  • BiologicalCandidate vaccine, SCB-1019T

    SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.

  • BiologicalAREXVY

    positive comparator

  • Otherplacebo

    Placebo Comparator

06

What researchers measure

Primary outcomes

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

    Proportion of participants with local and systemic solicited AEs

    Time frame: Within 7 days after vaccination

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

    Proportion of participants with unsolicited AEs

    Time frame: Within 28 days after vaccination

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

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

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

07

Study locations

5 of 5 sites recruiting
  • AMR Phoenix
    Phoenix, Arizona 85282, United States
    Recruiting
  • AMR Fort Myers
    Fort Myers, Florida 33912, United States
    Recruiting
  • AMR Lexington
    Lexington, Kentucky 40509, United States
    Recruiting
  • AMR Kansas City
    Kansas City, Missouri 64114, United States
    Recruiting
  • Knoxville
    Knoxville, Tennessee 37909, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Mar 2026, 11 months after the start.

Of 44 industry-sponsored phase 1 interventional studies under Respiratory Syncytial Virus Infections, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 10. This study's planned 11 months is above that.

Counting every sponsor, half of 57 studies reached it within 8 months; a quarter within 4 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2025
First posted
Feb 24, 2025
StartActual
Mar 21, 2025
Primary completionEst.
Mar 3, 2026
CompletionEst.
Jun 3, 2026
Last update
May 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06843317
Lead sponsor
Clover Biopharmaceuticals USA, LLC
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Mar 21, 2025
Primary completion
Mar 3, 2026 (estimated)
Completion
Jun 3, 2026 (estimated)
Last update
May 14, 2025

Study contacts

Xuesong Pei, MD
Contact
xuesong.pei@cloverbiopharma.com
(+86) 18515445890

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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