Pfizer C4931020

Purpose of this Study

We are doing this study to find out if an experimental vaccine called PG4 is a safe and effective option to protect against pneumococcal disease. We want to find out if the study vaccine can prevent or reduce the severity of these infections in older adults.

Who Can Participate?

Eligibility

Adults ages 65-84 who:
  • Are in good general health
  • Have not received a pneumococcal vaccine (e.g., Vaxneuvance, Prevnar 20, CAPVAXIVE, or Pneumovax23) in the past 5 years
  • Have not been hospitalized or had to change medications because of a worsening health condition in the past 12 weeks
  • Do not have a history of any of the following medical conditions: autoimmune disorder, blood cancer, HIV, solid organ transplant, cirrhosis, severe kidney disease, or any lung disease that requires the use of supplemental oxygen
For more information about who can join this study, please contact the study team at dvtustudies@duke.edu or 919-971-5649. You can also get in touch with us by filling out an online contact form: https://duke.qualtrics.com/jfe/form/SV_9tUb8z2G83DSWOy

Age Range

65-84

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes

What is Involved?

Description

The study vaccine will be given with or without adjuvants called PA-001 and PA-002, which are also experimental. Adjuvants are designed to enhance the effectiveness of vaccines so that they can provide more powerful and longer-lasting protection. After your first study visit, you will get a random assignment (by chance) to 1 of 6 groups:
  • Group 1: If you are in this group, you will get PG4 with a lower dose of PA-001
  • Group 2: If you are in this group, you will get PG4 with a higher dose of PA-001
  • Group 3: If you are in this group, you will get PG4 with a lower dose of PA-002
  • Group 4: If you are in this group, you will get PG4 with a higher dose of PA-002
  • Group 5: If you are in this group, you will get PG4 with no adjuvant
  • Group 6: If you are in this group, you will get Prevnar 20 (an FDA-approved vaccine for pneumococcal disease)

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS

Study Website

Study Website

Principal Investigator

Michael
Smith

Protocol Number

PRO00118817

NCT ID

NCT07086677

Phase

I

Enrollment Status

Open to Enrollment
ClinicalTrials.gov