Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants
| Autor: | Kurt Dobbelaere, Olumuyiwa Owolabi, Martin Antonio, Aderonke Odutola, Dorota Borys, Martin Okechukwu C. Ota, Archibald Worwui, Brian Greenwood, Magali Traskine, Ezra O. Ogundare, Yauba Saidu, Kristien Swinnen, Olubukola T. Idoko, Mark R. Alderson, Beate Kampmann, Patrick K. Owiafe, Vincent Verlant |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
030231 tropical medicine Serogroup medicine.disease_cause Measles Pneumococcal Infections Pneumococcal conjugate vaccine Haemophilus influenzae Pneumococcal Vaccines 03 medical and health sciences Immunogenicity Vaccine 0302 clinical medicine Bacterial Proteins Antibody Specificity medicine Humans 030212 general & internal medicine Immunization Schedule Antigens Bacterial Vaccines Conjugate Reactogenicity General Veterinary General Immunology and Microbiology business.industry Immunogenicity Age Factors Public Health Environmental and Occupational Health Toxoid Infant medicine.disease Antibodies Bacterial Vaccination Streptococcus pneumoniae Infectious Diseases Pneumococcal vaccine Immunology Molecular Medicine Female Gambia business medicine.drug |
| ISSN: | 0264-410X |
| Popis: | Background Two conserved pneumococcal proteins, pneumolysin toxoid (dPly) and pneumococcal histidine triad protein D (PhtD), combined with 10 polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in two investigational pneumococcal vaccine (PHiD-CV/dPly/PhtD) formulations were immunogenic and well-tolerated when administered to Gambian children. Here, we report immunogenicity of the polysaccharide conjugates, and immunogenicity and reactogenicity of co-administered routine vaccines. Methods In this phase II, controlled, observer-blind, single-centre study, healthy infants aged 8–10 weeks were randomised (1:1:1:1:1:1) to six groups. Four groups received 3+0 schedule (2-3-4 months [M]) of PHiD-CV/dPly/PhtD (10 or 30 µg of each protein), PHiD-CV, or 13-valent pneumococcal conjugate vaccine; and two groups received 2+1 schedule (2-4-9 M) of PHiD-CV/dPly/PhtD (30 µg of each protein) or PHiD-CV. All infants received diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HBV/Hib) and oral trivalent polio vaccines (OPV) at 2-3-4 M, and measles, yellow fever, and OPV vaccines at 9 M. We evaluated immune responses at 2-5-9-12 M; and reactogenicity 0–3 days post-vaccination. Results 1200 infants were enrolled between June 2011 and May 2012; 1152 completed the study. 1 M post-primary vaccination, for each PHiD-CV serotype except 6B and 23F, ≥97.4% (3+0 schedule) and ≥96.4% (2+1 schedule) of infants had antibody concentrations ≥0.2 μg/mL. Immune responses were comparable between groups within the same vaccination schedules. Observed antibody geometric mean concentrations (GMCs) increased by 1 M post-primary vaccination compared to pre-vaccination. In the following months, GMCs and opsonophagocytic activity titres waned, with an increase post-booster for the 2+1 schedule. Immune responses to protein D and, DTPw-HBV/Hib, OPV, measles, and yellow fever vaccines were not altered by co-administration with pneumococcal proteins. Reactogenicity of co-administered vaccines was comparable between groups and did not raise concerns. Conclusion Immune responses to the 10 PHiD-CV polysaccharide conjugates and co-administered vaccines were not altered by addition of dPly and PhtD. ClinicalTrials.gov identifier NCT01262872. |
| Databáze: | OpenAIRE |
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