NCT01160172

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults

Completed Phase 1 Last updated 30 May 2017

What this trial tests

Phase 1 trial testing Staphylococcal investigational vaccine GSK2392103A in Infections, Staphylococcal in 88 participants. Completed in 23 August 2012.

Timeline

19 July 2010

Primary endpoint
23 August 2012

23 August 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	88
Start date	19 July 2010
Primary completion	23 August 2012
Estimated completion	23 August 2012
Sites	1 location across Belgium

Drugs / interventions tested

• Staphylococcal investigational vaccine GSK2392103A — full drug profile →
• Staphylococcal investigational vaccine GSK2392105A — full drug profile →
• Staphylococcal investigational vaccine GSK2392106A — full drug profile →
• Staphylococcal investigational vaccine GSK2392019A — full drug profile →
• Saline placebo

Conditions studied

• Infections, Staphylococcal — all drugs for Infections, Staphylococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 40, any sex, with Infections, Staphylococcal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.

Publications & conference data

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

1. Development of a vaccine against Staphylococcus aureus.
   Spellberg B, Daum R. · · 2012 · cited 94× · PMID 22080194 · DOI 10.1007/s00281-011-0293-5
2. Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial.
   Levy J, Licini L, Haelterman E, Moris P, et al · · 2015 · cited 48× · PMID 25715157 · DOI 10.1080/21645515.2015.1011021
3. Opsonic and protective properties of antibodies raised to conjugate vaccines targeting six Staphylococcus aureus antigens.
   Pozzi C, Wilk K, Lee JC, Gening M, et al · · 2012 · cited 44× · PMID 23077517 · DOI 10.1371/journal.pone.0046648
4. The impact of human vaccines on bacterial antimicrobial resistance. A review.
   Jansen KU, Gruber WC, Simon R, Wassil J, et al · · 2021 · cited 39× · PMID 34602924 · DOI 10.1007/s10311-021-01274-z
5. Role and plasticity of Th1 and Th17 responses in immunity to <i>Staphylococcus aureus</i>.
   Ferraro A, Buonocore SM, Auquier P, Nicolas I, et al · · 2019 · cited 29× · PMID 31149870 · DOI 10.1080/21645515.2019.1613126
6. Preclinical Efficacy of Clumping Factor A in Prevention of Staphylococcus aureus Infection.
   Li X, Wang X, Thompson CD, Park S, et al · · 2016 · cited 22× · PMID 26838725 · DOI 10.1128/mbio.02232-15
7. Applying Convergent Immunity to Innovative Vaccines Targeting Staphylococcus aureus.
   Yeaman MR, Filler SG, Schmidt CS, Ibrahim AS, et al · · 2014 · cited 21× · PMID 25309545 · DOI 10.3389/fimmu.2014.00463
8. &lt;i&gt;Staphylococcus aureus&lt;/i&gt; in Inflammation and Pain: Update on Pathologic Mechanisms.
   Rasquel-Oliveira FS, Ribeiro JM, Martelossi-Cebinelli G, Costa FB, et al · · 2025 · cited 13× · PMID 40005560 · DOI 10.3390/pathogens14020185