Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV

Sponsor
argenx
Study ID
NCT05163834
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Efgartigimod — BIOLOGICAL
    intravenous infusion of efgartigimod
  • Placebo — OTHER
    intravenous infusion of placebo
  • PNEUMOVAX 23 — BIOLOGICAL
    PNEUMOVAX 23 vaccine

Study Details

This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.

Key Dates

Start date
Nov 17, 2021
Status verified
Mar 2022
Primary completion
Mar 8, 2022
Completion
Mar 8, 2022

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Efgartigimod-1
    Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 22
  • Experimental: Efgartigimod-2
    Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 36
  • Placebo Comparator: Placebo
    Weekly placebo infusions and the pneumovax 23 vaccine on day 22

Primary Outcome Measure

Variation in the immune response assessed by comparing pneumococcal capsular polysaccharide (PCP) titers pre- and postadministration of the PNEUMOVAX 23 vaccine between study arms [ Time Frame: throughout the study (up to 12 weeks) ]

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