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

ConditionRSV Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorClover Biopharmaceuticals USA, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.

Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.

Individuals willing and able to give an informed consent, prior to screening.

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).

Disqualifiers

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.

Recurrent or un-controlled neurological disorders or seizures.

Serious or unstable chronic illnesses

Any history of dementia or any medical condition that moderately or severely impairs cognition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Candidate vaccine, SCB-1019T

    Biological/Vaccine

    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™.

  • AREXVY

    Biological/Vaccine

    positive comparator

  • placebo

    Other intervention

    Placebo Comparator

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Group 1 (SCB-1019T)Experimental treatment 1 intervention
Group B: Group 2 (SCB-1019T)Experimental treatment 1 intervention
Group C: Group 3 (AREXVY)Active comparator 1 intervention
Group D: Group 4 (Placebo)Placebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clover Biopharmaceuticals USA, LLC

Lead sponsor

Source ClinicalTrials.gov
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