Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial.

Animals Humans Adult Hemorrhagic Fever, Ebola / prevention & control Ebola Vaccines Pan troglodytes Uganda Sudan Ebolavirus / genetics Antibodies, Viral Adenoviruses, Simian / genetics Adenoviridae / genetics Glycoproteins Immunogenicity, Vaccine Double-Blind Method

Journal

The Lancet. Infectious diseases
ISSN: 1474-4457
Titre abrégé: Lancet Infect Dis
Pays: United States
ID NLM: 101130150

Informations de publication

Date de publication:
Dec 2023
Historique:
received: 04 04 2023
revised: 09 05 2023
accepted: 10 05 2023
medline: 27 11 2023
pubmed: 7 8 2023
entrez: 6 8 2023
Statut: ppublish

Résumé

Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and therapeutics specific for Zaire Ebola virus have been approved for use during outbreak situations, Sudan Ebola virus is an antigenically distinct virus with no approved vaccines available. In this phase 1, open-label, dose-escalation trial we evaluated the safety, tolerability, and immunogenicity of a monovalent chimpanzee adenovirus 3 vaccine against Sudan Ebola virus (cAd3-EBO S) at Makerere University Walter Reed Project in Kampala, Uganda. Study participants were recruited from the Kampala metropolitan area using International Review Board-approved written and electronic media explaining the trial intervention. Healthy adults without previous receipt of Ebola, Marburg, or cAd3 vectored-vaccines were enrolled to receive cAd3-EBO S at either 1 × 10 40 healthy adults were enrolled between July 22 and Oct 1, 2019, with 20 receiving 1 × 10 The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset and durability of the vaccine-induced antibodies make this vaccine a strong candidate for emergency deployment in Sudan Ebola virus outbreaks. National Institutes of Health via interagency agreement with Walter Reed Army Institute of Research.

Sections du résumé

BACKGROUND BACKGROUND
Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and therapeutics specific for Zaire Ebola virus have been approved for use during outbreak situations, Sudan Ebola virus is an antigenically distinct virus with no approved vaccines available.
METHODS METHODS
In this phase 1, open-label, dose-escalation trial we evaluated the safety, tolerability, and immunogenicity of a monovalent chimpanzee adenovirus 3 vaccine against Sudan Ebola virus (cAd3-EBO S) at Makerere University Walter Reed Project in Kampala, Uganda. Study participants were recruited from the Kampala metropolitan area using International Review Board-approved written and electronic media explaining the trial intervention. Healthy adults without previous receipt of Ebola, Marburg, or cAd3 vectored-vaccines were enrolled to receive cAd3-EBO S at either 1 × 10
FINDINGS RESULTS
40 healthy adults were enrolled between July 22 and Oct 1, 2019, with 20 receiving 1 × 10
INTERPRETATION CONCLUSIONS
The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset and durability of the vaccine-induced antibodies make this vaccine a strong candidate for emergency deployment in Sudan Ebola virus outbreaks.
FUNDING BACKGROUND
National Institutes of Health via interagency agreement with Walter Reed Army Institute of Research.

Identifiants

DOI: 10.1016/S1473-3099(23)00344-4 PMID: 37544326
pubmed: 37544326
pii: S1473-3099(23)00344-4
doi: 10.1016/S1473-3099(23)00344-4
pii:
doi:

Substances chimiques

Ebola Vaccines 0
Antibodies, Viral 0
Glycoproteins 0

Banques de données

ClinicalTrials.gov
['NCT04041570']

Types de publication

Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1408-1417

Investigateurs

Jaqueline Namugabo (J)
Claire Beingana (C)
Maureen G Mukyala (MG)
Joseph Wandege (J)
Christine Nanteza (C)
Brenda Atwijuka (B)
Juliet Kizanye (J)
Gertrude Nassanga (G)
Joanita Namuli (J)
Herbert Kityo (H)
Mathias Ssekitoleko (M)
Roy Nassaka (R)
Hilda Mutebe (H)
Mable Kabahubya (M)
Alicia T Widge (AT)
Sarah E O'Connell (SE)
Obrimpong Amoa-Awua (O)
Sandeep R Narpala (SR)
Britta Flach (B)
Josephine Cox (J)
Allison Beck (A)
Mercy Guech (M)
Ellie Seo (E)
Judy A Stein (JA)

Commentaires et corrections

Type : ErratumIn

Informations de copyright

Copyright © 2023 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests NJS is listed on patents involving cAd3-vectored vaccines. All other authors declare no competing interests.

Auteurs

Betty Mwesigwa (B)

Makerere University Walter Reed Project, Kampala, Uganda.

Katherine V Houser (KV)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: katherine.houser@nih.gov.

Amelia R Hofstetter (AR)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Ana M Ortega-Villa (AM)

Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Prossy Naluyima (P)

Makerere University Walter Reed Project, Kampala, Uganda.

Francis Kiweewa (F)

Makerere University Walter Reed Project, Kampala, Uganda.

Immaculate Nakabuye (I)

Makerere University Walter Reed Project, Kampala, Uganda.

Galina V Yamshchikov (GV)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Charla Andrews (C)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Mark O'Callahan (M)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Larisa Strom (L)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Steven Schech (S)

Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Leigh Anne Eller (L)

Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Erica L Sondergaard (EL)

Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Paul T Scott (PT)

Walter Reed Army Institute of Research, Silver Spring, MD, USA.

Mihret F Amare (MF)

Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.

Kayvon Modjarrad (K)

Walter Reed Army Institute of Research, Silver Spring, MD, USA.

Amir Wamala (A)

Makerere University Walter Reed Project, Kampala, Uganda.

Allan Tindikahwa (A)

Makerere University Walter Reed Project, Kampala, Uganda.

Ezra Musingye (E)

Makerere University Walter Reed Project, Kampala, Uganda.

Jauhara Nanyondo (J)

Makerere University Walter Reed Project, Kampala, Uganda.

Martin R Gaudinski (MR)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Ingelise J Gordon (IJ)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

LaSonji A Holman (LA)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Jamie G Saunders (JG)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Pamela J M Costner (PJM)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Floreliz H Mendoza (FH)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Myra Happe (M)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Patricia Morgan (P)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Sarah H Plummer (SH)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Somia P Hickman (SP)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Sandra Vazquez (S)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Tamar Murray (T)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Jamilet Cordon (J)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Caitlyn N M Dulan (CNM)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Ruth Hunegnaw (R)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Manjula Basappa (M)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Marcelino Padilla (M)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Suprabhath R Gajjala (SR)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Phillip A Swanson (PA)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Bob C Lin (BC)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Emily E Coates (EE)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Jason G Gall (JG)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Adrian B McDermott (AB)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Richard A Koup (RA)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

John R Mascola (JR)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Aurélie Ploquin (A)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Nancy J Sullivan (NJ)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Hannah Kibuuka (H)

Makerere University Walter Reed Project, Kampala, Uganda.

Julie A Ake (JA)

Walter Reed Army Institute of Research, Silver Spring, MD, USA.

Julie E Ledgerwood (JE)

Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

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