Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age : A Phase 1/2 Randomized Trial
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America..
BACKGROUND: Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants.
METHODS: Healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years.
RESULTS: Two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post-ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post-dose 2.
CONCLUSIONS: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response. Clinical Trials Registration. NCT03636906.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:229 |
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| Enthalten in: |
The Journal of infectious diseases - 229(2024), 1 vom: 12. Jan., Seite 95-107 |
| Sprache: |
Englisch |
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| Links: |
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| Anmerkungen: |
Date Completed 25.01.2024 Date Revised 25.01.2024 published: Print ClinicalTrials.gov: NCT03636906 Citation Status MEDLINE |
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| doi: |
10.1093/infdis/jiad271 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM359782264 |
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| 100 | 1 | |a Sáez-Llorens, Xavier |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age |b A Phase 1/2 Randomized Trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 25.01.2024 | ||
| 500 | |a Date Revised 25.01.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT03636906 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. | ||
| 520 | |a BACKGROUND: Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants | ||
| 520 | |a METHODS: Healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years | ||
| 520 | |a RESULTS: Two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post-ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post-dose 2 | ||
| 520 | |a CONCLUSIONS: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response. Clinical Trials Registration. NCT03636906 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ChAd155 | |
| 650 | 4 | |a RSV | |
| 650 | 4 | |a immunogenicity | |
| 650 | 4 | |a infant | |
| 650 | 4 | |a vaccine-associated enhanced respiratory disease | |
| 650 | 7 | |a Antibodies, Neutralizing |2 NLM | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Respiratory Syncytial Virus Vaccines |2 NLM | |
| 700 | 1 | |a Norero, Ximena |e verfasserin |4 aut | |
| 700 | 1 | |a Mussi-Pinhata, Marisa Márcia |e verfasserin |4 aut | |
| 700 | 1 | |a Luciani, Kathia |e verfasserin |4 aut | |
| 700 | 1 | |a de la Cueva, Ignacio Salamanca |e verfasserin |4 aut | |
| 700 | 1 | |a Díez-Domingo, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Lopez-Medina, Eduardo |e verfasserin |4 aut | |
| 700 | 1 | |a Epalza, Cristina |e verfasserin |4 aut | |
| 700 | 1 | |a Brzostek, Jerzy |e verfasserin |4 aut | |
| 700 | 1 | |a Szymański, Henryk |e verfasserin |4 aut | |
| 700 | 1 | |a Boucher, François D |e verfasserin |4 aut | |
| 700 | 1 | |a Cetin, Benhur S |e verfasserin |4 aut | |
| 700 | 1 | |a De Leon, Tirza |e verfasserin |4 aut | |
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| 700 | 1 | |a Gabriel, Miguel Ángel Marín |e verfasserin |4 aut | |
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| 700 | 1 | |a Anderson, Evan J |e verfasserin |4 aut | |
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