Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial
Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA...
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| Published in: | The Lancet infectious diseases Vol. 23; no. 3; pp. 352 - 360 |
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01-03-2023
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| Abstract | Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two.
We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1–11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356.
Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4–7 years and 23 aged 9–15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23–51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12–36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36–64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255–40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356–86 541), which was 101 times higher than the geometric mean concentration before the booster dose.
A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations.
Innovative Medicines Initiative 2 Joint Undertaking.
For the French translation of the abstract see Supplementary Materials section. |
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| AbstractList | BACKGROUNDChildren account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two.METHODSWe conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1-11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356.FINDINGSBetween July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4-7 years and 23 aged 9-15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23-51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12-36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36-64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255-40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356-86 541), which was 101 times higher than the geometric mean concentration before the booster dose.INTERPRETATIONA booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations.FUNDINGInnovative Medicines Initiative 2 Joint Undertaking.TRANSLATIONFor the French translation of the abstract see Supplementary Materials section. Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two. We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1-11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 10 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356. Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4-7 years and 23 aged 9-15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23-51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12-36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36-64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255-40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356-86 541), which was 101 times higher than the geometric mean concentration before the booster dose. A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations. Innovative Medicines Initiative 2 Joint Undertaking. For the French translation of the abstract see Supplementary Materials section. Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two. We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1–11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356. Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4–7 years and 23 aged 9–15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23–51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12–36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36–64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255–40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356–86 541), which was 101 times higher than the geometric mean concentration before the booster dose. A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations. Innovative Medicines Initiative 2 Joint Undertaking. For the French translation of the abstract see Supplementary Materials section. Summary Background Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two. Methods We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1–11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356. Findings Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4–7 years and 23 aged 9–15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23–51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12–36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36–64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255–40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356–86 541), which was 101 times higher than the geometric mean concentration before the booster dose. Interpretation A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations. Funding Innovative Medicines Initiative 2 Joint Undertaking. Translation For the French translation of the abstract see Supplementary Materials section. |
| Author | Balami, Ahmed Dahiru Deen, Abdul Tejan Luhn, Kerstin Samai, Mohamed Connor, Nicholas Edward Watson-Jones, Deborah Otieno, Godfrey Tuda Deen, Gibrilla Fadlu Manno, Daniela Borboh, Paul Kallon, Joseph Lowe, Brett Greenwood, Brian Adetola, Hammed Hassan Kroma, Mattu Tehtor Lawal, Bolarinde Joseph Koroma, Bockarie Choi, Edward Man-Lik Foster, Julie Leigh, Bailah Baiden, Frank McLean, Chelsea Conteh, Musa Bangura, Agnes Robinson, Cynthia Ayieko, Philip Keshinro, Babajide Gaddah, Auguste Njie, Yusupha Kamara, Abu Bakarr |
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sequence: 6 givenname: Joseph surname: Kallon fullname: Kallon, Joseph organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 7 givenname: Julie surname: Foster fullname: Foster, Julie organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 8 givenname: Musa surname: Conteh fullname: Conteh, Musa organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 9 givenname: Nicholas Edward surname: Connor fullname: Connor, Nicholas Edward organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 10 givenname: Bockarie surname: Koroma fullname: Koroma, Bockarie organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 11 givenname: Yusupha surname: Njie 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and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 17 givenname: Abdul Tejan surname: Deen fullname: Deen, Abdul Tejan organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 18 givenname: Edward Man-Lik surname: Choi fullname: Choi, Edward Man-Lik organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 19 givenname: Ahmed Dahiru surname: Balami fullname: Balami, Ahmed Dahiru organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 20 givenname: Auguste surname: Gaddah fullname: Gaddah, Auguste organization: Janssen Research and Development, Beerse, Belgium – sequence: 21 givenname: Chelsea surname: McLean fullname: McLean, Chelsea organization: Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 22 givenname: Kerstin surname: Luhn fullname: Luhn, Kerstin organization: Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 23 givenname: Hammed Hassan surname: Adetola fullname: Adetola, Hammed Hassan organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 24 givenname: Gibrilla Fadlu surname: Deen fullname: Deen, Gibrilla Fadlu organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 25 givenname: Mohamed surname: Samai fullname: Samai, Mohamed organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 26 givenname: Brett surname: Lowe fullname: Lowe, Brett organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 27 givenname: Cynthia surname: Robinson fullname: Robinson, Cynthia organization: Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 28 givenname: Bailah surname: Leigh fullname: Leigh, Bailah organization: College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone – sequence: 29 givenname: Brian surname: Greenwood fullname: Greenwood, Brian organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK – sequence: 30 givenname: Deborah surname: Watson-Jones fullname: Watson-Jones, Deborah organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK |
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| References | Callendret, Vellinga, Wunderlich (bib6) 2018; 13 Roozendaal, Hendriks, van Effelterre (bib10) 2020; 5 Vetter, Kaiser, Schibler, Ciglenecki, Bausch (bib3) 2016; 16 (bib2) May 30, 2019 (bib4) 2022 Anywaine, Barry, Anzala (bib8) 2022; 19 Pollard, Launay, Lelievre (bib15) 2021; 21 Larivière, Zola, Stoppie (bib19) 2021; 11 Mutua, Anzala, Luhn (bib12) 2019; 220 (bib18) 2022 Goldstein, Bockstal, Bart (bib16) 2022; 226 Anywaine, Whitworth, Kaleebu (bib13) 2019; 220 Ishola, Manno, Afolabi (bib9) 2022; 22 Afolabi, Ishola, Manno (bib7) 2022; 22 Lwanga, Lemeshow (bib17) 1991 Milligan, Gibani, Sewell (bib11) 2016; 315 (bib5) July 1, 2020 (bib1) 2019 Barry, Mutua, Kibuuka (bib14) 2021; 18 Vetter (10.1016/S1473-3099(22)00594-1_bib3) 2016; 16 Callendret (10.1016/S1473-3099(22)00594-1_bib6) 2018; 13 Afolabi (10.1016/S1473-3099(22)00594-1_bib7) 2022; 22 Anywaine (10.1016/S1473-3099(22)00594-1_bib8) 2022; 19 Milligan (10.1016/S1473-3099(22)00594-1_bib11) 2016; 315 Mutua (10.1016/S1473-3099(22)00594-1_bib12) 2019; 220 Pollard (10.1016/S1473-3099(22)00594-1_bib15) 2021; 21 Anywaine (10.1016/S1473-3099(22)00594-1_bib13) 2019; 220 Lwanga (10.1016/S1473-3099(22)00594-1_bib17) Goldstein (10.1016/S1473-3099(22)00594-1_bib16) 2022; 226 Barry (10.1016/S1473-3099(22)00594-1_bib14) 2021; 18 Ishola (10.1016/S1473-3099(22)00594-1_bib9) 2022; 22 Larivière (10.1016/S1473-3099(22)00594-1_bib19) 2021; 11 Roozendaal (10.1016/S1473-3099(22)00594-1_bib10) 2020; 5 |
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| Snippet | Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a... Summary Background Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and... BACKGROUNDChildren account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and... |
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| SubjectTerms | Adverse events Antibodies Antibodies, Viral Binding Breast feeding Child Children Ebola Vaccines Ebola virus Ebolavirus Enzyme-linked immunosorbent assay Epidemics Female Glycoproteins Headache Hemorrhagic Fever, Ebola - prevention & control Humans Immune response Immune system Immunogenicity Immunogenicity, Vaccine Immunoglobulin G Infectious diseases Informed consent Injection Malaria Public health Safety Translation Vaccines Vaccinia virus Vector-borne diseases Viral diseases Viruses |
| Title | Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial |
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