Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study

Vaccine

Volumn 35, Issue 2, 2017, Pages 375-384

  Frenck, Robert W ^a   Buddy Creech, C ^b   Sheldon, Eric A ^c,g   Seiden, David J ^d   Kankam, Martin K ^e   Baber, James ^f   Zito, Edward ^f,g   Hubler, Robin ^f   Eiden, Joseph ^f   Severs, Joseph M ^f   Sebastian, Shite ^f   Nanra, Jasdeep ^f   Jansen, Kathrin U ^f   Gruber, William C ^f   Anderson, Annaliesa S ^f   Girgenti, Douglas ^f,g  

^a CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c MIAMI RESEARCH ASSOCIATES   (United States)

^d Broward Research Group   (United States)

^e Vince and Associates Clinical Research   (United States)

^f PFIZER INC   (United States)

^g Pfizer Inc ^*  (United States)

Author keywords

Capsular polysaccharide; Clumping factor A; Functional antibodies; Manganese transporter C; Staphylococcus aureus; Vaccine

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; FIBRINOGEN; LIPOPROTEIN; MANGANESE TRANSPORTER C; PLACEBO; POLYSACCHARIDE; STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE; STAPHYLOCOCCUS VACCINE; UNCLASSIFIED DRUG; BACTERIAL ANTIGEN; BACTERIAL POLYSACCHARIDE; BACTERIAL PROTEIN; BACTERIUM ANTIBODY; OPSONIN; RECOMBINANT VACCINE;

ADAPTIVE IMMUNITY; ADULT; ANKLE FRACTURE; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BRAIN HEMORRHAGE; BREAST TENDERNESS; CHEMILUMINESCENCE IMMUNOASSAY; CHILL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSMENORRHEA; FATIGUE; FEMALE; FEVER; GINGIVA PAIN; HEADACHE; HUMAN; HYPERTENSION; IMMUNOASSAY; INJECTION SITE COLORATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; LOBAR PNEUMONIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MENORRHAGIA; MICROCYTIC ANEMIA; MULTICENTER STUDY; MYALGIA; NAUSEA; OCULAR PRURITUS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; VACCINATION; VACCINE IMMUNOGENICITY; VIRAL UPPER RESPIRATORY TRACT INFECTION; VOMITING; ADVERSE DRUG REACTION; AGED; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; IMMUNOLOGY; NORMAL HUMAN; PHAGOCYTOSIS; STAPHYLOCOCCUS AUREUS; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BACTERIAL PROTEINS; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; IMMUNOASSAY; MALE; OPSONIN PROTEINS; PHAGOCYTOSIS; PLACEBOS; POLYSACCHARIDES, BACTERIAL; STAPHYLOCOCCAL VACCINES; STAPHYLOCOCCUS AUREUS; VACCINES, SYNTHETIC;

EID: 85007001244     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.11.010     Document Type: Article

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