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

Conditions

• Respiratory Syncytial Virus Infections

Eligibility Criteria

Sex

ALL

Age

6 Months - 5 Years

Healthy Volunteers

Accepted

Interventions

• PIV5-vectored RSV Vaccine (BLB-201) Low Dose — BIOLOGICAL
  BLB201 10\^6 PFU
• PIV5-vectored RSV Vaccine (BLB-201) High Dose — BIOLOGICAL
  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).

Study Details

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.

Key Dates

First listed

Dec 19, 2022

Start date

Mar 9, 2023

Status verified

Jul 2026

Primary completion

Dec 30, 2028

Completion

Dec 30, 2028

Study Design

Enrollment

137 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
  6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
• Placebo Comparator: Group 1, infants (age 18-59 months), RSV+, Placebo
  4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
• Experimental: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
  6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
• Placebo Comparator: Group 2, infants (age 18-59 months), RSV+, Placebo
  4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
• Experimental: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
  16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
• Placebo Comparator: Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
  8 participants will be administered placebo by intranasal route on Day 1
• Experimental: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
  32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
• Active Comparator: Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
  16 participants will be administered placebo by intranasal route on Day 1
• Experimental: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
  30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
• Placebo Comparator: Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
  15 participants will be administered Placebo by intranasal route on Day 1 and Day 57

Primary Outcome Measure

Solicited Adverse Events [ Time Frame: Day 1-15 ]

Central Contacts

• Henry Radziewicz, MD PhD
  585-313-0027
  [email protected]
• Nubia Kaba
  585-313-0027
  [email protected]

Locations (16)

Find similar trials in La Mesa, CA

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