Safety and immune response of a new pneumococcal vaccine in adults 50 to 64

A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age

This trial will test whether the new pneumococcal vaccine Pn-MAPS30plus is safe and helps healthy adults aged 50 to 64 make protective antibodies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 50 Years to 64 Years
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Locations: 2 sites (Norwood, South Australia and 1 other locations)
• Trial ID: NCT07428759 on ClinicalTrials.gov

What this trial studies

This Phase 1, interventional study enrolls healthy or medically stable adults aged 50 to 64 who will receive a single dose of either the investigational Pn-MAPS30plus vaccine or the approved PCV20 vaccine and be followed for about six months. The trial focuses on safety/tolerability and measuring immune responses, primarily antibody production against pneumococcal serotypes. Participants will complete an electronic diary and attend scheduled clinic visits for monitoring and blood draws. Data from this early-stage trial will inform whether the formulation is well tolerated and elicits promising immune responses for further testing.

Who should consider this trial

Good fit: Healthy or medically stable adults aged 50 to 64 who can comply with study procedures (including completing an eDiary and attending follow-up visits) are the intended participants.

Not a fit: People outside the 50–64 age range, those with recent invasive pneumococcal disease or uncontrolled medical conditions, or those unable to attend study visits are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, Pn-MAPS30plus could provide an additional or broader option for preventing pneumococcal disease in middle-aged adults while maintaining an acceptable safety profile.

How similar studies have performed: Licensed vaccines such as PCV20 are effective, and MAPS-platform pneumococcal candidates have shown promising immunogenicity in early studies, but the MAPS approach is relatively novel and still under clinical evaluation.

Eligibility criteria

Inclusion Criteria:

1. Participants who, in the opinion of the investigator, can comply with the requirements (e.g., completion of the electronic diary \[eDiary\], return for follow-up visits).
2. Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
3. Healthy or medically stable adults confirmed by medical history and clinical examination at screening. Participants with stable medical conditions can be enrolled at the discretion of the investigator.
4. Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature.
5. Female participants of childbearing potential (POCBP) may enrol if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.

Exclusion Criteria:

1. History of microbiologically proven invasive pneumococcal disease (IPD) caused by S. pneumoniae within 3 years before study intervention administration.
2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition.
4. Hypersensitivity to latex.
5. Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
6. Documented HIV-positive status.
7. Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
8. Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.
9. Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
10. Any other clinical condition that, might pose additional risk to the participant.
11. Use of any investigational or non-registered product other than the study interventions within 30 days before the study intervention administration.
12. History of previous vaccination with any pneumococcal vaccine.
13. Administration of immunoglobulins or other blood products or plasma derivatives within 90 days before or planned within 30 days after study intervention.
14. Chronic administrations of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial.
15. Pregnant or lactating female participant.
16. History of and/or current chronic alcohol consumption and/or drug abuse, based on investigator judgment.

Where this trial is running

Norwood, South Australia and 1 other locations

• GSK Investigational Site — Norwood, South Australia, Australia (Recruiting)
• GSK Investigational Site — Camberwell, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Pneumonia, Bacterial; Pn-MAPS30plus; MAPS technology; pneumococcal vaccine; Phase 1; Healthy Adults; 50-64 years