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A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants

Primary Purpose

Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prevnar 13
AFX3772
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Bacterial

Eligibility Criteria

42 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.

Exclusion Criteria:

  • Had prior administration of any pneumococcal vaccine.
  • Has a known or suspected hypersensitivity to AFX3772, PCV13 or any components of the formulations used.
  • Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
  • Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
  • Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
  • Has received immunoglobulins.
  • Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
  • Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.
  • Has febrile illness at Visit 1.

Sites / Locations

  • The Children's Clinic of Jonesboro, P.A.
  • Madera Family Medical Group
  • Bio-Medical Research, LLC
  • SEC Clinical Research
  • St. John's Center for Clinical Research
  • Tekton Research
  • Meridian Clinical Research, LLC
  • MedPharmcis, LLC
  • Mankato Clinic
  • Boeson Research
  • Boeson Research
  • GSK Investigational Site
  • Meridian Clinical Research
  • Senders Pediatrics
  • Oklahoma State University- Center for Health Sciences
  • Cyn3rgy Research
  • Meridian Clinical Research
  • Tribe Clinical Research LLC
  • Tribe Clinical Research
  • Forest Lane Pediatrics, LLC
  • Bay Colony Pediatrics
  • Kool Kids Pediatrics
  • Pediatric Associates
  • Houston Clinical Research Associates
  • Kingsland Pediatrics
  • Pediatric Center
  • Tekton Research
  • Alliance for Multispecialty Research
  • Wee Care Pediatric
  • Cottonwood Pediatrics
  • GSK Investigational Site
  • Intermountain River Hospital
  • Alliance for Multispecialty Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

1 mcg AFX3772 administered intramuscularly 4 times within 12 months

2 mcg AFX3772 administered intramuscularly 4 times within 12 months

5 mcg AFX3772 administered intramuscularly 4 times within 12 months

PCV13 administered intramuscularly 4 times within 12 months

Outcomes

Primary Outcome Measures

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
Solicited injection site and systemic AEs post-vaccination
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
Adverse Events
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
Serious Adverse Events

Secondary Outcome Measures

To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13
Participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL
To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13
Serotype-specific IgG GMC

Full Information

First Posted
June 3, 2022
Last Updated
June 14, 2023
Sponsor
GlaxoSmithKline
Collaborators
Affinivax, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05412030
Brief Title
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants
Official Title
A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCV13 in Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
April 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Affinivax, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
1 mcg AFX3772 administered intramuscularly 4 times within 12 months
Arm Title
Group 2
Arm Type
Experimental
Arm Description
2 mcg AFX3772 administered intramuscularly 4 times within 12 months
Arm Title
Group 3
Arm Type
Experimental
Arm Description
5 mcg AFX3772 administered intramuscularly 4 times within 12 months
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
PCV13 administered intramuscularly 4 times within 12 months
Intervention Type
Biological
Intervention Name(s)
Prevnar 13
Intervention Description
PCV13 administered intramuscularly 4 times within 12 months
Intervention Type
Biological
Intervention Name(s)
AFX3772
Intervention Description
AFX3772 administered intramuscularly 4 times within 12 months
Primary Outcome Measure Information:
Title
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
Description
Solicited injection site and systemic AEs post-vaccination
Time Frame
Day 1 through Day 7 post-vaccination
Title
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
Description
Adverse Events
Time Frame
Day 1 through Day 30
Title
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
Description
Serious Adverse Events
Time Frame
Day 1 through study completion, an average of 13 months
Secondary Outcome Measure Information:
Title
To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13
Description
Participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL
Time Frame
30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four
Title
To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13
Description
Serotype-specific IgG GMC
Time Frame
30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Is a full-term infant approximately 2 months of age at time of obtaining the informed consent. Exclusion Criteria: Had prior administration of any pneumococcal vaccine. Has a known or suspected hypersensitivity to AFX3772, PCV13 or any components of the formulations used. Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive. Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series. Has a history of microbiologically proven invasive disease caused by S. pneumoniae. Has received immunoglobulins. Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection. Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine. Has febrile illness at Visit 1.
Facility Information:
Facility Name
The Children's Clinic of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Bio-Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
SEC Clinical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
St. John's Center for Clinical Research
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Tekton Research
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
MedPharmcis, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
Mankato Clinic
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Boeson Research
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
GSK Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Oklahoma State University- Center for Health Sciences
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Meridian Clinical Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Tribe Clinical Research LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29609
Country
United States
Facility Name
Tribe Clinical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Forest Lane Pediatrics, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Bay Colony Pediatrics
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Facility Name
Kool Kids Pediatrics
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Pediatric Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Houston Clinical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Kingsland Pediatrics
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Pediatric Center
City
Richmond
State/Province
Texas
ZIP/Postal Code
77469
Country
United States
Facility Name
Tekton Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
Alliance for Multispecialty Research
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wee Care Pediatric
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
Cottonwood Pediatrics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
GSK Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Intermountain River Hospital
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Alliance for Multispecialty Research
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants

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