NCT01905215

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines

Completed Phase 1 Last updated 30 May 2017

What this trial tests

Phase 1 trial testing RSV vaccine GSK3003892A (formulation 1) in Infections, Respiratory Syncytial Virus in 128 participants. Completed in 16 March 2015.

Timeline

22 July 2013

Primary endpoint
9 April 2014

16 March 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	128
Start date	22 July 2013
Primary completion	9 April 2014
Estimated completion	16 March 2015
Sites	3 locations across Canada

Drugs / interventions tested

• RSV vaccine GSK3003892A (formulation 1)
• RSV vaccine GSK3003893A (formulation 2) — full drug profile →
• RSV vaccine GSK3003895A (formulation 3) — full drug profile →
• RSV vaccine GSK3003896A (formulation 4) — full drug profile →
• RSV vaccine GSK3003898A (formulation 5) — full drug profile →
• RSV vaccine GSK3003899A (formulation 6) — full drug profile →
• Placebo comparator

Conditions studied

• Infections, Respiratory Syncytial Virus — all drugs for Infections, Respiratory Syncytial Virus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 44, male only, with Infections, Respiratory Syncytial Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.

Publications & conference data

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

1. Advances in Infectious Disease Vaccine Adjuvants.
   Fan J, Jin S, Gilmartin L, Toth I, et al · · 2022 · cited 68× · PMID 35891284 · DOI 10.3390/vaccines10071120
2. A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant.
   Langley JM, Aggarwal N, Toma A, Halperin SA, et al · · 2017 · cited 53× · PMID 27694633 · DOI 10.1093/infdis/jiw453
3. Ongoing developments in RSV prophylaxis: a clinician's analysis.
   Rezaee F, Linfield DT, Harford TJ, Piedimonte G. · · 2017 · cited 52× · PMID 28500974 · DOI 10.1016/j.coviro.2017.03.015
4. Quantifying maternally derived respiratory syncytial virus specific neutralising antibodies in a birth cohort from coastal Kenya.
   Nyiro JU, Sande C, Mutunga M, Kiyuka PK, et al · · 2015 · cited 27× · PMID 25725445 · DOI 10.1016/j.vaccine.2015.02.039
5. Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus.
   Verwey C, Madhi SA. · · 2023 · cited 24× · PMID 37097594 · DOI 10.1007/s40259-023-00596-4
6. Efficacy, immunogenicity and safety of respiratory syncytial virus prefusion F vaccine: systematic review and meta-analysis.
   Pang Y, Lu H, Cao D, Zhu X, et al · · 2024 · cited 15× · PMID 38711074 · DOI 10.1186/s12889-024-18748-8
7. Vaccines for the common cold.
   Montesinos-Guevara C, Buitrago-Garcia D, Felix ML, Guerra CV, et al · · 2022 · cited 3× · PMID 36515550 · DOI 10.1002/14651858.cd002190.pub6
8. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants.
   Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, et al · · 2020 · cited 1× · PMID 31951765 · DOI 10.1080/21645515.2019.1693749