Last updated: 09/03/2025 13:10:16
A sourcing study to collect human biological samples from healthy adults vaccinated with a licensed pneumococcal conjugate vaccine
GSK study ID
222927
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open-label, sourcing study to collect human biological samples prior to and/or following administration of a licensed pneumococcal conjugate vaccine in healthy adults 18 to 50 years of age
Trial description: The study aims to collect human biological samples from healthy adults (18-50 years) who will receive a licensed pneumococcal conjugate vaccine (PCV20, also known as Prevnar 20, in Part 1 of the study and PCV 21, also known as Capvaxive, in Part 2 of the study).For the development of pneumococcal vaccines, immunological testing is to be set up, developed, and maintained, thus requiring significant volumes of blood and urine samples from vaccinated individuals. At time of initial study design, PCV20 was the licensed pneumococcal conjugate vaccine capable of producing antibodies against the highest number of subtypes, i.e., 20. With the licensure of a new pneumococcal vaccine, called Capvaxive (PCV21), the study protocol has been amended to allow collection of human biological samples before and after administration of this vaccine in Part 2 of the study.In addition to the planned 240 healthy adults in Part 1 receiving PCV20, 144 healthy adults are planned to join Part 2 of the study to receive PCV21. The study is planning to collect blood and urine samples at different time points to support serological and urine assays set-up, development, and maintenance.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Blood samples to be collected pre- and/or post-vaccination in Part 1 and Part 2 of the study
Timeframe: Groups A and D: Day 8, Day 98, & Day 188 Groups B and E: Day 31 and Day 121 Groups C and F: Day 1, Day 98 and Day 188
Urine samples to be collected at the last timepoint post-vaccination in Part 2 of the study
Timeframe: Day 121 (Group E) and Day 188 (Groups D and F)
Secondary outcomes:
Number of Participants with Serious adverse events (SAEs) related to study procedures (blood collection and study intervention) and pregnancies
Timeframe: Groups A, C, D and F: Day 1 up to study end (Day 188) Groups B and E: Day 1 up to study end (Day 121)
Interventions:
Not applicable
Enrollment:
384
Primary completion date:
2025-04-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pneumonia, Bacterial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2024 to August 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 50 Years
Accepts healthy volunteers
Yes
- 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 2. Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- 1. History of microbiologically proven IPD (e.g., positive blood culture, cerebrospinal fluid culture or culture at another sterile site) caused by S. pneumoniae within the past 3 years prior to the study intervention administration.
- 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. Written informed consent obtained from the participant prior to performance of any study-specific procedure. 3. Healthy male/female participant between and including 18 and 50 years of age at the time of the first study visit. 4. Participants must weigh at least 110 pounds (50 kg). 5. Female participants of non-childbearing potential may be enrolled in the clinical study. 6. Female participants of childbearing potential may be enrolled in the clinical study.
Exclusion criteria:
- 1. History of microbiologically proven IPD (e.g., positive blood culture, cerebrospinal fluid culture or culture at another sterile site) caused by S. pneumoniae within the past 3 years prior to the study intervention administration. 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 4. Hypersensitivity to latex. 5. Clinical conditions representing a contraindication to intramuscular vaccination and blood collection. 6. Participants with blood disorders (e.g., congenital, or hemolytic anemias, hemochromatosis). 7. Participants with a history of difficulty in providing blood samples (bad veins). Participants who donated greater than (>) 450 mL of blood within 84 days prior to the first blood collection visit or plan to donate blood outside the protocol during the study period. 8. Ongoing anemia as indicated by hemoglobin values below the lower limit of the laboratory-specified reference range (e.g., hemoglobin <12.5 g/dL in females, and <13 g/dL in males). If the finger prick method demonstrates an anemia, no further protocol procedures will be performed, and the participant will be referred for appropriate medical management. 9. Documented history of HIV-positive participant. 10. Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination. 11. Recurrent history or uncontrolled neurological disorders (including neuroinflammatory and congenital neurological conditions) or seizures. 12. Previous vaccination with polysaccharide pneumococcal vaccine (PPSV23) or pneumococcal conjugate vaccines (PCV13/PCV15/PCV20/PCV21) vaccines within 5 years prior to enrollment in this study or planned administration during the study outside the protocol. Vaccination during infancy with any type of PCVs is allowed. 13. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or use of long-acting immune-modifying treatments:
- Up to 3 months prior to the first study visit: for corticosteroids, this will mean prednisone equivalent >= 20 mg/day for adult participants. Inhaled and topical steroids are allowed.
- Up to 6 months prior to first study visit: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- At any time up to the end of the study.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2025-04-08
Actual study completion date
2025-04-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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