NCT01767402

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations According to a 0-2 Month Schedule, in Healthy Adults

Completed Phase 1 Last updated 10 January 2013

What this trial tests

Phase 1 trial testing PhtD vaccine with/without adjuvant in Pneumococcal Disease in 150 participants. Completed in 1 November 2004.

Timeline

1 October 2003

Primary endpoint
1 November 2004

1 November 2004

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	1 October 2003
Primary completion	1 November 2004
Estimated completion	1 November 2004
Sites	1 location across Belgium

Drugs / interventions tested

• PhtD vaccine with/without adjuvant — full drug profile →
• Pneumovax 23TM — full drug profile →
• NaCl — full drug profile →

Conditions studied

• Pneumococcal Disease — all drugs for Pneumococcal Disease →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Pneumococcal Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Occurrence, intensity and relationship of any solicited local and general signs and symptoms
  Time frame: During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose
• Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
  Time frame: During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose
• Occurrence of all serious adverse events (SAEs)
  Time frame: During the 12 months of the study
• Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
  Time frame: One month after the first injection
• Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
  Time frame: One month after two injections

Sponsor's own description

The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy elderly population aged 18-45 years of age.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pneumococcal whole-cell and protein-based vaccines: changing the paradigm.
   Pichichero ME. · · 2017 · cited 50× · PMID 29130395 · DOI 10.1080/14760584.2017.1393335
2. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials.
   Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, et al · · 2015 · cited 45× · PMID 24176494 · DOI 10.1016/j.vaccine.2013.10.052
3. Emerging vaccine strategies against the incessant pneumococcal disease.
   Duke JA, Avci FY. · · 2023 · cited 39× · PMID 37591986 · DOI 10.1038/s41541-023-00715-w
4. Pneumococcal Surface Proteins as Virulence Factors, Immunogens, and Conserved Vaccine Targets.
   Aceil J, Avci FY. · · 2022 · cited 39× · PMID 35646747 · DOI 10.3389/fcimb.2022.832254
5. Safety, immunogenicity, and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults.
   Berglund J, Vink P, Tavares Da Silva F, Lestrate P, et al · · 2014 · cited 29× · PMID 24173029 · DOI 10.1128/cvi.00430-13
6. Recent progress in pneumococcal protein vaccines.
   Li S, Liang H, Zhao SH, Yang XY, et al · · 2023 · cited 18× · PMID 37818378 · DOI 10.3389/fimmu.2023.1278346
7. <i>Streptococcus pneumoniae</i> serotype distribution in low- and middle-income countries of South Asia: Do we need to revisit the pneumococcal vaccine strategy?
   Dhawale P, Shah S, Sharma K, Sikriwal D, et al · · 2025 · cited 3× · PMID 39999432 · DOI 10.1080/21645515.2025.2461844