A Study to Learn About How a New Pneumococcal Vaccine Works in Adults (NCT07086677)
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
Who can join: Review the eligibility criteria below.
Location: Orange County Research Center — Lake Forest, California
Age range: 65 Years to 84 Years
🧪 Interventions in This Study
- PG4 vaccine in Buffer 1 with low dose PA-001 (BIOLOGICAL)
- PG4 in Buffer 1 with low dose PA-002 (BIOLOGICAL)
- PG4 in Buffer 1 with high dose PA-001 (BIOLOGICAL)
- PG4 vaccine in Buffer 1 with high dose PA-002 (BIOLOGICAL)
- PG4 vaccine in Buffer 2 (BIOLOGICAL)
- 20-valent pneumococcal conjugate vaccine (BIOLOGICAL)
- Saline injection (BIOLOGICAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Orange County Research Center — Lake Forest, California
- Peninsula Research Associates — Rolling Hills Estates, California
- Finlay Medical Research — Greenacres City, Florida
- Indago Research & Health Center, Inc. — Miami Lakes, Florida
- Johnson County Clinical Trials — Lenexa, Kansas
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO — Springfield, Missouri
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center — Springfield, Missouri
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO — Springfield, Missouri
- Velocity Clinical Research, Omaha — Omaha, Nebraska
- Upstate Global Health Institute — East Syracuse, New York
- NYU Langone Health Vaccine Center — New York, New York
- Duke Vaccine and Trials Unit — Durham, North Carolina
- CTI Clinical Research Center — Cincinnati, Ohio
- Headlands Horizons, LLC dba Headlands Research-Brownsville — Brownsville, Texas
- Valley Regional Medical Center — Brownsville, Texas
- LabCorp — Houston, Texas
- IMA Clinical Research San Antonio — San Antonio, Texas
- Dynamed Clinical Research, LP d/b/a DM Clinical Research — Tomball, Texas
- J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah
- J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.