A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age

NCT07105722 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 221544
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 4

Brief Summary

This clinical study is designed to evaluate an investigational pneumococcal vaccine named Pn-MAPS30plus. The vaccine is designed to stimulate the immune system to produce antibodies against various serotypes of the S. pneumoniae bacteria, potentially aiding the body in fighting infection upon exposure. Pn-MAPS30plus aims to broaden protection by covering more serotypes than currently licensed pneumococcal vaccines. The study's purpose is to determine whether the vaccine is safe, well-tolerated, and effective in inducing immune responses against S. pneumoniae.

Conditions

Pneumonia, Bacterial

Keywords

Streptococcus pneumoniae; Pn-MAPS30plus; 20 valent pneumococcal conjugate vaccine (PCV20)

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Each Solicited Administration Site (Local) Event

  Day 1 (post-vaccination) to Day 7

• Number of Participants with Each Solicited Systemic Event

  Day 1 (post-vaccination) to Day 7

• Number of Participants with Any Unsolicited Adverse Events (AEs)

  Day 1 (post-vaccination) to Day 30

• Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal

  Day 1 up to trial end (Month 6)

• Number of Participants with Hematological and Biochemical Laboratory Abnormalities

  On Day 8

Study Arms (2)

Pn-MAPS30plus Group

EXPERIMENTAL

Participants receive a single dose of Pn-MAPS30plus on Day 1.

Biological: Pn-MAPS30plus

PCV20 Group

ACTIVE COMPARATOR

Participants receive a single dose of PCV20 on Day 1.

Combination Product: PCV20

Interventions

Pn-MAPS30plus BIOLOGICAL

The Pn-MAPS30plus vaccine will be administered intramuscularly.

Pn-MAPS30plus Group

PCV20 COMBINATION_PRODUCT

The PCV20 vaccine will be administered intramuscularly.

PCV20 Group

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
• Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
• Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.

You may not qualify if:

• History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Hypersensitivity to latex.
• Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
• Documented history of Human immunodeficiency virus (HIV)-positive participant.
• Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
• Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.
• Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with trial participation.
• History of potential immune-mediated disorders (pIMDs).
• Any other clinical condition that, might pose additional risk to the participant.
• Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the study intervention administration.
• History of previous vaccination with any pneumococcal vaccine.
• Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt within 30 days of study intervention administration.
• Chronic administration 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Norwood, South Australia, 5067, Australia

Location

GSK Investigational Site

Bayswater, Victoria, 3153, Australia

Location

GSK Investigational Site

Camberwell, Victoria, 3124, Australia

Location

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be conducted in an observer-blind manner.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 6, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

AU (4)