NCT03838497

Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

Completed Phase 4 Last updated 12 February 2019

What this trial tests

Phase 4 trial testing Prevenar13 in Streptococcal Pneumonia in 70 participants. Completed in 28 February 2017.

Timeline

2 April 2015

Primary endpoint
31 January 2017

28 February 2017

Quick facts

Lead sponsor	Korea University Guro Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	70
Start date	2 April 2015
Primary completion	31 January 2017
Estimated completion	28 February 2017

Drugs / interventions tested

• Prevenar13

Conditions studied

• Streptococcal Pneumonia — all drugs for Streptococcal Pneumonia →
• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Korea University Guro Hospital

Who can join

18 and older, any sex, with Streptococcal Pneumonia or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts \<350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults in the era of highly active antiretroviral therapy: analysis stratified by CD4 T-cell count.
   Song JY, Cheong HJ, Noh JY, Choi MJ, et al · · 2020 · cited 13× · PMID 31441710 · DOI 10.1080/21645515.2019.1643677