AFX3772 for Pneumonia, Pneumococcal

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. John's Center for Clinical Research, Saint Augustine, FL
Pneumonia, Pneumococcal+1 More
AFX3772 - Biological
Eligibility
< 18
All Sexes
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Study Summary

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different dose levels of AFX3772 compared with PCV13. Infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. Enrollment in Cohorts 2 and 3 will proceed following Data Monitoring Committee (DMC) review of cumulative safety and tolerability data from preceding cohorts. Following completion of DMC review of safety and tolerability data for the cohorts enrolled in Part 1, additional infants will be enrolled and randomized equally to receive either PCV13 or AFX3772 at different dose levels approved for evaluation in Part 2.

Eligible Conditions

  • Pneumonia, Pneumococcal
  • Pneumococcal Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pneumonia, Pneumococcal

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four

Day 30
To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13
Month 13
To describe the safety and tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 with respect to the proportion of participants with AEs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Pneumonia, Pneumococcal

Trial Design

4 Treatment Groups

Group 4
1 of 4
Group 1
1 of 4
Group 3
1 of 4
Group 2
1 of 4
Active Control
Experimental Treatment

472 Total Participants · 4 Treatment Groups

Primary Treatment: AFX3772 · No Placebo Group · Phase 2

Group 1
Biological
Experimental Group · 1 Intervention: AFX3772 · Intervention Types: Biological
Group 3
Biological
Experimental Group · 1 Intervention: AFX3772 · Intervention Types: Biological
Group 2
Biological
Experimental Group · 1 Intervention: AFX3772 · Intervention Types: Biological
Group 4
Biological
ActiveComparator Group · 1 Intervention: Prevnar 13 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four
Closest Location: St. John's Center for Clinical Research · Saint Augustine, FL
2009First Recorded Clinical Trial
1 TrialsResearching Pneumonia, Pneumococcal
2 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.