Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults

Daniel A Scott; Steven F Komjathy; Branda T Hu; Sherryl Baker; Lois A Supan; Carol A Monahan; William Gruber; George R Siber; Stephen P Lockhart

doi:10.1016/j.vaccine.2007.06.004

Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults

Vaccine. 2007 Aug 14;25(33):6164-6. doi: 10.1016/j.vaccine.2007.06.004. Epub 2007 Jun 26.

Authors

Daniel A Scott¹, Steven F Komjathy, Branda T Hu, Sherryl Baker, Lois A Supan, Carol A Monahan, William Gruber, George R Siber, Stephen P Lockhart

Affiliation

¹ Wyeth Vaccines Research, 401 N. Middletown Road, Pearl River, NY 10965, USA.

PMID: 17629361
DOI: 10.1016/j.vaccine.2007.06.004

Abstract

In a Phase 1 study, 15 healthy subjects were randomized to receive a 13-valent pneumococcal conjugate vaccine (PCV13) and 15 to receive a 23-valent pneumococcal polysaccharide vaccine (23vPS). Antibody responses were measured immediately before and approximately one month after vaccination. Serotype-specific antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) for immunoglobulin G (IgG) and an opsonophagocytic assay (OPA) for functional antibodies. PCV13 was as immunogenic or more immunogenic than 23vPS and was well tolerated.

Publication types

Clinical Trial, Phase I
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Antibodies, Bacterial / blood
Enzyme-Linked Immunosorbent Assay
Health*
Humans
Immunoglobulin G / blood
Middle Aged
Pneumococcal Infections / immunology*
Pneumococcal Vaccines / immunology*

Substances

Antibodies, Bacterial
Immunoglobulin G
Pneumococcal Vaccines