Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial

November 11, 2024

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Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial

Publicated to:Journal Of Infectious Diseases. 229 (1): 95-107 - 2024-01-12 229(1), DOI: 10.1093/infdis/jiad271

Authors: Saez-Llorens, Xavier; Norero, Ximena; Mussi-Pinhata, Marisa Marcia; Luciani, Kathia; Salamanca de la Cueva, Ignacio; Diez-Domingo, Javier; Lopez-Medina, Eduardo; Epalza, Cristina; Brzostek, Jerzy; Szymanski, Henryk; Boucher, Francois D; Cetin, Benhur S; De Leon, Tirza; Dinleyici, Ener Cagri; Marin Gabriel, Miguel Angel; Ince, Tolga; Macias-Parra, Mercedes; Langley, Joanne M; Martinon-Torres, Federico; Ramet, Mika; Kuchar, Ernest; Pinto, Jorge; Puthanakit, Thanyawee; Baquero-Artigao, Fernando; Gattinara, Guido Castelli; Merino Arribas, Jose Manuel; Ramos Amador, Jose Tomas; Szenborn, Leszek; Tapiero, Bruce; Anderson, Evan J; Campbell, James D; Faust, Saul N; Nikic, Vanja; Zhou, Yingjun; Pu, Wenji; Friel, Damien; Dieussaert, Ilse; Lopez, Antonio Gonzalez; McPhee, Roderick; Stoszek, Sonia K; Vanhoutte, Nicolas

Affiliations

Caja Seguro Social, Hosp Especialidades Pediat Omar Torrijos Herrera, Dept Infect Dis, Panama City, Panama - Author

Cevaxin Sede David, Dept Vaccines, Chiriqui, Panama - Author

Chulalongkorn Univ, Dept Pediat, Fac Med, Bangkok, Thailand - Author

Ctr Invest Biomed Red Enfermedades Infecciosas, Madrid, Spain - Author

Ctr Vacunac Int, Vaccine Res Dept, Panama City, Panama - Author

Dalhousie Univ, IWK Hlth & Nova Scotia Hlth, Canadian Ctr Vaccinol, Halifax, NS, Canada - Author

Dokuz Eylul Univ, Fac Med, Dept Social Pediat, Izmir, Turkiye - Author

Emory Univ, Sch Med, Dept Med, Atlanta, GA USA - Author

Emory Univ, Sch Med, Dept Pediat, Atlanta, GA USA - Author

Erciyes Univ, Fac Med, Dept Pediat Infect Dis, Kayseri, Turkiye - Author

Eskisehir Osmangazi Univ, Fac Med, Dept Pediat, Eskisehir, Turkiye - Author

Fdn Invest Biomed Hosp 12 Octubre, Inst Invest Sanitaria Hosp Octubre 12, Hosp Univ Octubre 12, Pediat Infect Dis Unit,Dept Pediat,Res & Clin Tra, Madrid, Spain - Author

FISABIO Fdn Fomento Invest Sanitaria & Biomed Com, Ctr Invest Biomed Red Epidemiol & Publ Hlth, Valencia, Spain - Author

Grp Inst Hispalense Pediat, Unidad Invest, Seville, Spain - Author

GSK, Biostat, Rockville, MD USA - Author

GSK, Vaccines, Wavre, Belgium - Author

Healthcare Res Inst Santiago de Compostela, Vaccines Infect & Pediat Res Grp, Santiago De Compostela, Spain - Author

Hosp Clin Univ Santiago de Compostela, Dept Pediat, Translat Pediat & Infect Dis Sect, Santiago De Compostela, Spain - Author

Hosp Nino Dr Jose Renan Esquivel, Dept Infect Dis, Panama City, Panama - Author

Hosp Univ Infantil La Paz, Ctr Invest Biomed Red Enfermedades Infecciosas, Serv Pediat Enfermedades Infecciosas & Trop, ISCIII, Madrid, Spain - Author

Inst Nacl Pediat, Mexico City, DF, Mexico - Author

Inst Salud Carlos III, Ctr Invest Biomed Red Resp Dis, Madrid, Spain - Author

Med Univ Warsaw, Dept Pediat, Clin Assessment Unit, Warsaw, Poland - Author

Moderna Inc, Cambridge, MA USA - Author

Nuevo Hosp Univ Burgos, Dept Pediat, Burgos, Spain - Author

Osped Pediat Bambino Gesu, Ist Ricovero & Cura Carattere Sci, Dipartimento Pediat Univ Osped, Ctr Vaccinaz, Rome, Italy - Author

Sabin Vaccine Inst, Washington, DC USA - Author

Secretaria Nacl Ciencia & Tecnol, Panama City, Panama - Author

Sistema Nacl Invest, Panama City, Panama - Author

St Hedwig Silesia Hosp, Dept Pediat, Trzebnica, Poland - Author

Tampere Univ, Vaccine Res Ctr, Tampere, Finland - Author

Univ Autonoma Madrid, Hosp Univ Puerta de Hierro Majadahonda, Dept Pediat, Madrid, Spain - Author

Univ Complutense, Inst Invest Sanitaria Hosp Clin San Carlos, Dept Pediat, Madrid, Spain - Author

Univ Fed Minas Gerais, Sch Med, Dept Pediat, Belo Horizonte, MG, Brazil - Author

Univ Hosp Southampton Natl Hlth Serv Fdn Trust, Biomed Res Ctr, Southampton, Hants, England - Author

Univ Hosp Southampton Natl Hlth Serv Fdn Trust, Natl Inst Hlth & Care Res Southampton Clin Res Fa, Southampton, Hants, England - Author

Univ Laval, Ctr Hosp Univ Quebec, Dept Pediat, Quebec City, PQ, Canada - Author

Univ Maryland, Sch Med, Dept Pediat, Ctr Vaccine Dev & Global Hlth, Baltimore, MD 21201 USA - Author

Univ Montreal, Ctr Hosp Univ St Justine, Montreal, PQ, Canada - Author

Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Pediat, Sao Paulo, Brazil - Author

Univ Southampton, Fac Med, Southampton, Hants, England - Author

Univ Southampton, Inst Life Sci, Southampton, Hants, England - Author

Univ Valle, Ctr Estudios Infectol Pediat, Dept Pediat, Clin Imbanaco,Grp Quironsalud, Cali, Colombia - Author

Wroclaw Med Univ, Dept Pediat & Infect Dis, Wroclaw, Poland - Author

Zespol Opieki Zdrowotnej Debicy, Oddzial Dzieciecy, Debica, Poland - Author

Abstract

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 x 10(10) viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 x 10(10) 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.

Keywords

Chad155Chimpanzee-derived adenoviral vector vaccineImmunogenicityInfantRespiratory tract infectionRsvSafetyVaccine-associated enhanced respiratory diseasVaccine-associated enhanced respiratory disease

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Journal Of Infectious Diseases due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position 19/137, thus managing to position itself as a Q1 (Primer Cuartil), in the category Infectious Diseases.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 3.02, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Oct 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-10-26, the following number of citations:

WoS: 3
Scopus: 7

Impact and social visibility

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Belgium; Brazil; Canada; Colombia; Finland; Italy; Mexico; Panama; Poland; Thailand; Turkey; United Kingdom; United States of America.

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Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial

Affiliations

Abstract

Keywords

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

Impact and social visibility

Leadership analysis of institutional authors