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A Randomized Controlled Clinical Trial of Nasal Immunization with Live Virulence Attenuated Strains Using Human Infection Challenge. | LitMetric

AI Article Synopsis

  • - Pneumococcal pneumonia is a major global health concern, and the study explores whether nasal delivery of live attenuated strains (Spn) could enhance immunity and prevent infections.
  • - A trial involving 125 healthy adults tested the effects of nasal administration of different Spn strains, revealing that those exposed to certain genetically modified strains showed some degree of protection against later wild-type strain recolonization.
  • - The findings indicate that nasal colonization with safe, genetically modified live attenuated Spn can promote immunity, suggesting a potential new approach for preventing pneumococcal infections.

Article Abstract

Pneumococcal pneumonia remains a global health problem. Pneumococcal colonization increases local and systemic protective immunity, suggesting that nasal administration of live attenuated (Spn) strains could help prevent infections. We used a controlled human infection model to investigate whether nasopharyngeal colonization with attenuated strains protected against recolonization with wild-type (WT) Spn (SpnWT). Healthy adults aged 18-50 years were randomized (1:1:1:1) for nasal administration twice (at a 2-wk interval) with saline solution, WT Spn6B (BHN418), or one of two genetically modified Spn6B strains, SpnA1 () or SpnA3 () (Stage I). After 6 months, participants were challenged with SpnWT to assess protection against the homologous serotype (Stage II). 125 participants completed both study stages per intention to treat. No serious adverse events were reported. In Stage I, colonization rates were similar among groups: SpnWT, 58.1% (18 of 31); SpnA1, 60% (18 of 30); and SpnA3, 59.4% (19 of 32). Anti-Spn nasal IgG levels after colonization were similar in all groups, whereas serum IgG responses were higher in the SpnWT and SpnA1 groups than in the SpnA3 group. In colonized individuals, increases in IgG responses were identified against 197 Spn protein antigens and serotype 6 capsular polysaccharide using a pangenome array. Participants given SpnWT or SpnA1 in Stage I were partially protected against homologous challenge with SpnWT (29% and 30% recolonization rates, respectively) at stage II, whereas those exposed to SpnA3 achieved a recolonization rate similar to that in the control group (50% vs. 47%, respectively). Nasal colonization with genetically modified live attenuated Spn was safe and induced protection against recolonization, suggesting that nasal administration of live attenuated Spn could be an effective strategy for preventing pneumococcal infections. Clinical trial registered with the ISRCTN registry (ISRCTN22467293).

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Source
http://dx.doi.org/10.1164/rccm.202302-0222OCDOI Listing

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