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A Study of BLB-201 RSV Vaccine in Infants and Children

ConditionRespiratory Syncytial Virus Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-5
SponsorBlue Lake Biotechnology Inc.

About this trial

This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10\^6 PFU and 10\^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • PIV5-vectored RSV Vaccine (BLB-201) Low Dose

    Biological/Vaccine

    BLB201 10\^6 PFU

  • PIV5-vectored RSV Vaccine (BLB-201) High Dose

    Biological/Vaccine

    BLB201 10\^7 PFU

  • Placebo

    Drug

    The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).

Treatment groups

137 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFUExperimental treatment 1 intervention
Group B: Group 1, infants (age 18-59 months), RSV+, PlaceboPlacebo comparator 1 intervention
Group C: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFUExperimental treatment 1 intervention
Group D: Group 2, infants (age 18-59 months), RSV+, PlaceboPlacebo comparator 1 intervention
Group E: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFUExperimental treatment 1 intervention
Group F: Group 3, children (age 8-24 months), RSV+ or RSV-, PlaceboPlacebo comparator 1 intervention
Group G: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFUExperimental treatment 1 intervention
Group H: Group 4, children (age 8-24 months), RSV+ or RSV-, PlaceboActive comparator 1 intervention
Group I: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFUExperimental treatment 1 intervention
Group J: Group 6, children (age 8-24 months), RSV+ or RSV-, PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Solicited Adverse Events

Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.

Time frame
Day 1-15
2

Unsolicited Adverse Events

Frequencies and grades of unsolicited AEs during a 28-day period after dosing.

Time frame
Day 1-29

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Blue Lake Biotechnology Inc.

Lead sponsor

Source ClinicalTrials.gov
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