Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study

Autor: Novalene Goklish, Kristien Swinnen, Yue Song, Mathuram Santosham, Magali Traskine, Robert Weatherholtz, Katherine L. O'Brien, Raymond Reid, James C. Campbell, Lawrence H. Moulton, Laura L. Hammitt, Dorota Borys
Rok vydání: 2019
Předmět:
Male
medicine.medical_specialty
Hydrolases
Immunization
Secondary
medicine.disease_cause
Pneumococcal conjugate vaccine
Pneumococcal Vaccines
03 medical and health sciences
0302 clinical medicine
Immunogenicity
Vaccine
Bacterial Proteins
030225 pediatrics
Internal medicine
Streptococcus pneumoniae
medicine
Humans
030212 general & internal medicine
Adverse effect
Respiratory Tract Infections
Immunization Schedule
Reactogenicity
Vaccines
Conjugate
General Veterinary
General Immunology and Microbiology
business.industry
Immunogenicity
Public Health
Environmental and Occupational Health
Toxoid
Infant
Newborn
Infant
Pneumonia
Pneumococcal
Vaccine efficacy
Antibodies
Bacterial
Otitis Media
Infectious Diseases
Pneumococcal vaccine
Acute Disease
Streptolysins
Vaccines
Subunit
Molecular Medicine
Female
Patient Safety
business
medicine.drug
Zdroj: Vaccine. 37(51)
ISSN: 1873-2518
Popis: Background Native American populations experience a substantial burden of pneumococcal disease despite use of highly effective pneumococcal conjugate vaccines (PCVs). Protein-based pneumococcal vaccines may extend protection beyond the serotype-specific protection elicited by PCVs. Methods In this phase IIb, double-blind, controlled trial, 6–12 weeks-old Native American infants randomized 1:1, received either a protein-based pneumococcal vaccine (dPly/PhtD) containing pneumolysin toxoid (dPly, 10 µg) and pneumococcal histidine triad protein D (PhtD, 10 µg) or placebo, administered along with 13-valent PCV (PCV13) at ages 2, 4, 6 and 12–15 months. Other pediatric vaccines were given per the routine immunization schedule. We assessed vaccine efficacy (VE) against acute otitis media (AOM) and acute lower respiratory tract infection (ALRI) endpoints. Immunogenicity, reactogenicity and unsolicited adverse events were assessed in a sub-cohort and serious adverse events were assessed in all children. Results 1803 infants were randomized (900 dPly/PhtD; 903 Control). VE against all episodes of American Academy of Pediatrics (AAP)-defined AOM was 3.8% (95% confidence interval: −11.4, 16.9). Point estimates of VE against other AOM outcomes ranged between 2.9% (−9.5, 14.0) and 5.2% (−8.0, 16.8). Point estimates of VE against ALRI outcomes ranged between −4.4% (−39.2, 21.8) and 2.0% (−18.3, 18.8). Point estimates of VE tended to be higher against first than all episodes but the confidence intervals included zero. dPly/PhtD vaccine was immunogenic and had an acceptable reactogenicity and safety profile after primary and booster vaccination in Native American infants. Conclusions The dPly/PhtD vaccine was immunogenic and well tolerated, however, incremental efficacy in preventing AAP-AOM over PCV13 was not demonstrated. Clinical trials registration NCT01545375 ( www.clinicaltrials.gov )
Databáze: OpenAIRE
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