Immunogenicity and safety of 11-and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study
| Autor: | Alfonso Carmona Martinez, Magali Traskine, Michael Horn, Jerzy Brzostek, Dorota Borys, Renata Ruzkova, Mariano Miranda Valdivieso, Roman Prymula, Leszek Szenborn, Fernando Centeno-Malfaz, María del Carmen Otero Reigada, Jose Manuel Merino Arribas, Teresa Jackowska, Kurt Dobbelaere |
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| Rok vydání: | 2019 |
| Předmět: |
Serotype
Male Infants/children Booster dose medicine.disease_cause Pneumococcal conjugate vaccine Haemophilus influenzae Pneumococcal Vaccines Non-inferiority 0302 clinical medicine Immunogenicity Vaccine 030212 general & internal medicine Immunogenicity PHiD-CV Antibodies Bacterial Vaccination Infectious Diseases Streptococcus pneumoniae Molecular Medicine Female Safety medicine.drug Lipoproteins 030231 tropical medicine Immunization Secondary Serogroup Pneumococcal Infections 03 medical and health sciences Bacterial Proteins medicine Humans Hepatitis B Vaccines Vaccines Combined Diphtheria-Tetanus-Pertussis Vaccine Reactogenicity Vaccines Conjugate General Veterinary General Immunology and Microbiology business.industry Public Health Environmental and Occupational Health Infant Immunoglobulin D Poliovirus Vaccine Inactivated Pneumococcal vaccine Immunology business Carrier Proteins |
| Zdroj: | Vaccine r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 0264-410X |
| Popis: | Background: We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRIA(197)-conjugated capsular polysaccharides of serotypes 19A (11-valent) or 19A and 6A (12-valent). Methods: In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM197-conjugate pneumococcal vaccine (PCV13), at 2, 3, and 4 (primary series), and 12-15 months of age (booster dose), co-administered with DTPa-HBV-IPV/Hib. Confirmatory objectives assessed non-inferiority of investigational vaccines to comparators (PHiD-CV for common serotypes; PCV13 for 19A and 6A), in terms of percentage of infants with pneumococcal antibody concentrations >= 0.2 mu g/mL and antibody geometric mean concentrations, post-primary vaccination. Reactogenicity and safety were assessed. Results: 951 children received >= 1 primary dose, 919 a booster dose. Pre-defined immunological non inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations >= 0.2 AgirnL were >96.7% post-primary (except 6B [>= 75.2%] and 23F [>= 81.1%]), and >= 98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, >= 81.0% and >= 93.9% of children had opsonophagocytic activity titres >= 8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded. Conclusion: Addition of 19A and 6A CRM197-conjugates did not alter immunogenicity of the PHiD-CV conjugates; for both investigational vaccines post-booster immune responses to 10 common serotypes appeared similar to those elicited by PHiD-CV. Safety and reactogenicity profiles of the investigational vaccines were comparable to PHiD-CV. (C) 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license. |
| Databáze: | OpenAIRE |
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