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1. Ebola Virus Glycoprotein IgG Seroprevalence in Community Previously Affected by Ebola, Sierra Leone

Author

Daniela Manno, Philip Ayieko, David Ishola, Muhammed O. Afolabi, Baimba Rogers, Frank Baiden, Alimamy Serry-Bangura, Osman M. Bah, Brian Köhn, Ibrahim Swaray, Kwabena Owusu-Kyei, Godfrey T. Otieno, Dickens Kowuor, Daniel Tindanbil, Elizabeth Smout, Cynthia Robinson, Babajide Keshinro, Julie Foster, Katherine Gallagher, Brett Lowe, Macaya Douoguih, Bailah Leigh, Brian Greenwood, and Deborah Watson-Jones

Subjects
Ebola virus, viruses, zoonoses, IgG, antibodies, seroprevalence, Medicine, Infectious and parasitic diseases, RC109-216
Abstract

We explored the association of Ebola virus antibody seropositivity and concentration with potential risk factors for infection. Among 1,282 adults and children from a community affected by the 2014–2016 Ebola outbreak in Sierra Leone, 8% were seropositive for virus antibodies but never experienced disease symptoms. Antibody concentration increased with age.

Published
2022
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2. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Author

David Ishola, Daniela Manno, Muhammed O Afolabi, Babajide Keshinro, Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E Gallagher, Auguste Gaddah, Dirk Heerwegh, Benoit Callendret, Kerstin Luhn, Cynthia Robinson, Maarten Leyssen, Brian Greenwood, Macaya Douoguih, Bailah Leigh, Deborah Watson-Jones, M Kargbo, E Bockarie, N L James, A Kabbah, A Kamara, K H Koroma, S O Langley, N William, R Kessebeh, T Mooney, L Conteh, E Smout, K Allieu, K Bangura, M S Bangura, M A Bangura, H Jalloh, A B Jalloh, I Kamara, M Kamara, A Konteh, S Koroma, C Marrah, M Sesay, M T Sesay, A T Deen, A Jalloh, R M Kaimbay, D Kain, E L Kamara, M P Kamara, O J Kamara, S L M Kamara, M Kanneh, A H Koroma, D Lahai, I S Mansaray, W S Marah, M J Massaquoi, A Nabie, N S Saidu, I Samai, J N Tengheh, A S Turay, A Fornah, F Sesay, A Sow, E Swaray, F Mansaray, T Ade-Cole, L M Bangura, M L Conteh, A M Koroma, M Koroma, A Sam, T Scott, T Sessie, J-H C Sunders, S I-S Turay, J Weekes, M Sheku, L Gibson, D Kowuor, I Ahamed, W Allieu, D U Kabba, F J Kamara, M S Kebbie, M Pessima, A Wurie, F Bah, A I Bangura, R A S Bangura, L Blango, S Boima, M Conteh, Y Conteh, M L Daramy, O Fofanah, E George, T F Hanson, M I Jalloh, M Kalawa, A M Kamara, F E Kamara, G M Kamara, H M Kamara, P B D Kamara, R T Kamara, R Kamara, D P Kanneh, I Komeh, M Kuyateh, F F Mansaray, M M Mansaray, A B Sillah, M A Tarawally, O S Turya, J B Yawmah, B Leigh, D Watson-Jones, B Greenwood, M H Samai, G F Deen, D Marke, P Piot, P Smith, J Edmunds, S Lees, H Larson, H Weiss, P Wilson, C Maxwell, D Ishola, M Afolabi, F Baiden, P Akoo, K Owusu-Kyei, D Tindanbil, H Bower, J Stuart, O M Bah, B T Rogers, A Serry-Bangura, I B Swaray, A Bangura, I J David, D G M Davies, J A Kallon, A B Kamara, I F Kamara, M M Kamara, F E Morovia, F B Suma, F Thompson, M Murray, I Sesay, O Kakay, F Suma, J Foster, R Philips, D Manno, K Gallager, S Cox, N Howard, M Cesay, P Torrani, S Sharma, E Snowden, T Banks, T Harber, J Brown, K Howard, N Melton, S Malcolm, S Welsh, R Eggo, M Jendrossek, C Pearson, J Van Hoof, M Douoguih, K Offergelt, C Robinson, B Keshinro, M Van Alst, N Mahajan, V Bockstal, N Goldstein, A Gaddah, D Heerwegh, K Luhn, M Leyssen, B Lowe, K Awuondo, H Hafezi, E Hancox, B Kohn, G O Tuda, F Koroma, G Bangura, M T Kroma, L Fofanah, A Pessima, M Rogers, O Sheriff, T W Ajala, J Fangawa, S Foday Jr, I Jabbie, B Mansaray, H A Mansaray, K Sesay, M K Charles, P C Heroe, M L Karbo, IS Yansaneh, S G Egoeh, A Trye, M Amponsah, N D Alghali, A Bah, IJ Bangura, A C Cole, K Fofanah, S Fofanah, H U Jalloh, K F N Jalloh, N Jalloh, H U Kabba, J N Kabba, M Kabba, J S Kamara, F Kanjie, A P Kanu, I Kargbo, G Kassa-Koroma, S B Koroma, A Sankoh, T Sankoh, O D Sesay, H Wilhem, C T Williams, I Bangura, Y Ben-Rogers, F J Jamboria, N Kamara, I Kanawah, A T Kargbo, I Swaray, L Amara, I Bundu, H B Jakema, K Kamara, M F Sheku, Q Adeleye, I Akhigbe, R Bakalemwa, N P Chami, T Sylvester, L Altmann, B Kamara, K van Roey, P Conteh, M Samura, V Gandie, M Marrah, E Moinina, J Kalokoh, M I Bangura, S Bosompem, T Hilton, M O Jusu, P Borboh, A S Brima, A F Y Caulker, A Kallon, B Koroma, RC Macauley, T M D Saquee, H I Williams, A R Bangura, J Fornah, B Idriss, M Sillah, W Mackay, B Aleghen, T Murray, J Edem-Hotah, T Fatorma, F Amara, S Bangura, E Bonnie, M Sannoh, A Donaldson, S Ndingi, D Nyaberi, M Pereira, A Rothwell, V Vy, L Nyallay, A Fombah, S Saidu, N Connor, T P Dambo, P J Fakaba, M M E Fatorma, C L Johnson, D B Kogba, A Lahai, W Vincent, N Yambasu, M Bangura, A Tengbeh, R Kabia, AM Nyakoi, M Callaghan, L Enria, and S Lee

Subjects
Adult, Male, medicine.medical_specialty, Modified vaccinia Ankara, Booster dose, Antibodies, Viral, Sierra Leone, Sierra leone, Immunogenicity, Vaccine, Double-Blind Method, Viral Envelope Proteins, Internal medicine, Vaccines, DNA, Humans, Medicine, Ebola Vaccines, Adverse effect, Heterologous vaccine, Ebola vaccine, business.industry, Vaccination, Viral Vaccines, Hemorrhagic Fever, Ebola, Ebolavirus, Immunity, Humoral, Regimen, Infectious Diseases, Democratic Republic of the Congo, Female, business
Abstract

Background: The Ebola epidemics in west Africa and the Democratic Republic of the Congo highlight an urgent need for safe and effective vaccines to prevent Ebola virus disease. We aimed to assess the safety and long-term immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in Sierra Leone, a country previously affected by Ebola. Methods: The trial comprised two stages: an open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2. The study was done at three clinics in Kambia district, Sierra Leone. In stage 1, healthy adults (aged ≥18 years) residing in or near Kambia district, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) on day 1 (first dose) followed by an intramuscular injection of MVA-BN-Filo (1 × 108 infectious units) on day 57 (second dose). An Ad26.ZEBOV booster vaccination was offered at 2 years after the first dose to stage 1 participants. The eligibility criteria for adult participants in stage 2 were consistent with stage 1 eligibility criteria. Stage 2 participants were randomly assigned (3:1), by computer-generated block randomisation (block size of eight) via an interactive web-response system, to receive either the Ebola vaccine regimen (Ad26.ZEBOV followed by MVA-BN-Filo) or an intramuscular injection of a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo on day 57 (second dose; control group). Study team personnel, except those with primary responsibility for study vaccine preparation, and participants were masked to study vaccine allocation. The primary outcome was the safety of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen, which was assessed in all participants who had received at least one dose of study vaccine. Safety was assessed as solicited local and systemic adverse events occurring in the first 7 days after each vaccination, unsolicited adverse events occurring in the first 28 days after each vaccination, and serious adverse events or immediate reportable events occurring up to each participant's last study visit. Secondary outcomes were to assess Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second vaccine in a per-protocol set of participants (ie, those who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response) and to assess the safety and tolerability of the Ad26.ZEBOV booster vaccination in stage 1 participants who had received the booster dose. This study is registered at ClinicalTrials.gov, NCT02509494. Findings: Between Sept 30, 2015, and Oct 19, 2016, 443 participants (43 in stage 1 and 400 in stage 2) were enrolled; 341 participants assigned to receive the Ad26.ZEBOV and MVA-BN-Filo regimen and 102 participants assigned to receive the MenACWY and placebo regimen received at least one dose of study vaccine. Both regimens were well tolerated with no safety concerns. In stage 1, solicited local adverse events (mostly mild or moderate injection-site pain) were reported in 12 (28%) of 43 participants after Ad26.ZEBOV vaccination and in six (14%) participants after MVA-BN-Filo vaccination. In stage 2, solicited local adverse events were reported in 51 (17%) of 298 participants after Ad26.ZEBOV vaccination, in 58 (24%) of 246 after MVA-BN-Filo vaccination, in 17 (17%) of 102 after MenACWY vaccination, and in eight (9%) of 86 after placebo injection. In stage 1, solicited systemic adverse events were reported in 18 (42%) of 43 participants after Ad26.ZEBOV vaccination and in 17 (40%) after MVA-BN-Filo vaccination. In stage 2, solicited systemic adverse events were reported in 161 (54%) of 298 participants after Ad26.ZEBOV vaccination, in 107 (43%) of 246 after MVA-BN-Filo vaccination, in 51 (50%) of 102 after MenACWY vaccination, and in 39 (45%) of 86 after placebo injection. Solicited systemic adverse events in both stage 1 and 2 participants included mostly mild or moderate headache, myalgia, fatigue, and arthralgia. The most frequent unsolicited adverse event after the first dose was headache in stage 1 and malaria in stage 2. Malaria was the most frequent unsolicited adverse event after the second dose in both stage 1 and 2. No serious adverse event was considered related to the study vaccine, and no immediate reportable events were observed. In stage 1, the safety profile after the booster vaccination was not notably different to that observed after the first dose. Vaccine-induced humoral immune responses were observed in 41 (98%) of 42 stage 1 participants (geometric mean binding antibody concentration 4784 ELISA units [EU]/mL [95% CI 3736–6125]) and in 176 (98%) of 179 stage 2 participants (3810 EU/mL [3312–4383]) at 21 days after the second vaccination. Interpretation: The Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults. Funding: Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.

Published
2022

3. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Author

Muhammed O Afolabi, David Ishola, Daniela Manno, Babajide Keshinro, Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E Gallagher, Auguste Gaddah, Dirk Heerwegh, Benoit Callendret, Kerstin Luhn, Cynthia Robinson, Brian Greenwood, Maarten Leyssen, Macaya Douoguih, Bailah Leigh, Deborah Watson-Jones, M Kargbo, E Bockarie, N L James, A Kabbah, A Kamara, K H Koroma, S O Langley, N William, R Kessebeh, T Mooney, L Conteh, E Smout, K Allieu, K Bangura, M S Bangura, M A Bangura, H Jalloh, A B Jalloh, I Kamara, M Kamara, A Konteh, S Koroma, C Marrah, M Sesay, M T Sesay, A T Deen, A Jalloh, R M Kaimbay, D Kain, E L Kamara, M P Kamara, O J Kamara, S L M Kamara, M Kanneh, A H Koroma, D Lahai, I S Mansaray, W S Marah, M J Massaquoi, A Nabie, N S Saidu, I Samai, J N Tengheh, A S Turay, A Fornah, F Sesay, A Sow, E Swaray, F Mansaray, T Ade-Cole, L M Bangura, M L Conteh, A M Koroma, M Koroma, A Sam, T Scott, T Sessie, J-H C Sunders, S I-S Turay, J Weekes, M Sheku, L Gibson, D Kowuor, I Ahamed, W Allieu, D U Kabba, F J Kamara, M S Kebbie, M Pessima, A Wurie, F Bah, A I Bangura, R A S Bangura, L Blango, S Boima, M Conteh, Y Conteh, M L Daramy, O Fofanah, E George, T F Hanson, M I Jalloh, M Kalawa, A M Kamara, F E Kamara, G M Kamara, H M Kamara, P B D Kamara, R T Kamara, R Kamara, D P Kanneh, I Komeh, M Kuyateh, F F Mansaray, M M Mansaray, A B Sillah, M A Tarawally, O S Turya, J B Yawmah, B Leigh, D Watson-Jones, B Greenwood, M H Samai, G F Deen, D Marke, T Sesay, P Piot, P Smith, J Edmunds, S Lees, H Larson, H Weiss, P Wilson, R Phillips, C Maxwell, D Ishola, M Afolabi, F Baiden, P Akoo, K Owusu-Kyei, D Tindanbil, H Bower, J Stuart, O M Bah, B T Rogers, A Serry-Bangura, I B Swaray, A Bangura, I J David, D G M Davies, J A Kallon, A B Kamara, I F Kamara, M M Kamara, F E Morovia, F B Suma, F Thompson, M Murray, O Kakay, F Suma, I Sesay, J Foster, D Manno, K Gallagher, S Cox, N Howard, M Cesay, P Torrani, S Sharma, E Snowden, T Banks, T Harber, J Brown, K Howard, N Melton, S Malcolm, S Welsh, R Eggo, M Jendrossek, C Pearson, K Offergeld, C Ferrault, M Van Alst, N Mahajan, M Van Looveren, S Van Ballaert, T De Cnodder, N Grobler, L Roza, T Liberi, L Armishaw, C Verkleij, T Henrick, A Banaszkiewicz, B Lowe, K Awuondo, H Hafezi, E Hancox, B Kohn, G O Tuda, G Bangura, M T Kroma, L Fofanah, A Pessima, M Rogers, O Sheriff, T W Ajala, J Fangawa, S Foday Jr, I S F Koroma, B Mansaray, H A Mansaray, K Sesay, M K Charles, P C Heroe, M Lamin Karbo, I S Yansaneh, S Gogo Egoeh, A Trye, M Amponsah, L Donelson, T Sylvester, V Owira, G Onyuka, L Nambuchi, A Oburu, D Apollo, L Vandi, N D Alghali, A Bah, I J Bangura, A C Cole, S Fofanah, H U Jalloh, K F N Jalloh, N Jalloh, H U Kabba, J N Kabba, M Kabba, J S Kamara, F Kanjie, A P Kanu, I Kargbo, G Kassa-Koroma, S B Koroma, A Sankoh, T Sankoh, O D Sesay, H Wilhem, C T Williams, I Bangura, Y Ben-Rogers, F J Jamboria, N Kamara, I Kanawah, A T Kargbo, I Swaray, L Amara, I Bundu, H B Jakema, K Kamara, M F Sheku, Q Adeleye, I Akhigbe, R Bakalemwa, N P Chami, L Altmann, B Kamara, K van Roey, P Conteh, M Samura, V Gandie, M Marrah, E Moinina, J Kalokoh, S Bosompem, T Hilton, M O Jusu, P Borboh, A S Brima, A F Y Caulker, A Kallon, B Koroma, R C Macauley, T M D Saquee, H I Williams, A R Bangura, J Fornah, B Idriss, M Sillah, W Mackay, B Aleghen, T Murray, J Edem-Hotah, T Fatorma, F Amara, S Bangura, E Bonnie, M Sannoh, A Donaldson, S Ndingi, D Nyaberi, M Pereira, A Rothwell, V Vy, L Nyallay, A Fombah, S Saidu, T P Dambo, P J Fakaba, M M E Fatorma, R H Freeman, C L Johnson, D B Kogba, A Lahai, W Vincent, N Yambasu, M Bangura, A Tengbeh, R Kabia, A M Nyakoi, M Callaghan, L Enria, and S Lee

Subjects
Male, Modified vaccinia Ankara, Pediatrics, medicine.medical_specialty, Adolescent, Antibodies, Viral, medicine.disease_cause, Injections, Intramuscular, Drug Administration Schedule, Sierra Leone, Sierra leone, Immunogenicity, Vaccine, Vaccines, DNA, Humans, Medicine, Ebola Vaccines, Child, Reactogenicity, Heterologous vaccine, Ebola virus, Ebola vaccine, business.industry, Infant, Viral Vaccines, Ebolavirus, Vaccination, Regimen, Infectious Diseases, Child, Preschool, Female, business
Abstract

Summary Background Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. Methods This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1–17 years were enrolled in three age cohorts (12–17 years, 4–11 years, and 1–3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov , NCT02509494 . Findings From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1–3 years after placebo injection to 21% (30 of 144) of children aged 4–11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12–17 years and 4–11 years age cohorts after the first and second dose, and pyrexia in the 1–3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12–17 years (9929 ELISA units [EU]/mL [95% CI 8172–12 064]), in 119 (99%) of 120 aged 4–11 years (10 212 EU/mL [8419–12 388]), and in 118 (98%) of 121 aged 1–3 years (22 568 EU/mL [18 426–27 642]). Interpretation The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children. Funding Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.

Published
2022

4. Safety and immunogenicity of a two-dose Ad26. ZEBOV, MVA-BN-Filo Ebola vaccine in children: a randomised, double-blind, controlled trial in Sierra Leone

Author

Muhammed O. Afolabi, David Ishola, Daniela Manno, Babajide Keshinro,Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T. Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E. Gallagher, Aug

Published
2021
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5. Safety and long-term immunogenicity of a two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen in adults: a randomised, double-blind, controlled trial in Sierra Leone

Author

David Ishola, Daniela Manno, Muhammed O. Afolabi, Babajide Keshinro, Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T. Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E. Gallagher, Aug

Published
2021
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6. Need for Local Laboratory Reference Values in Recruitment into Studies of Emerging Infectious Diseases: Insight from Participant Screening for an Ebola Vaccine Trial in a Rural African Setting

Author

David Ishola, Bailah Leigh, Emma Hancox, Hannah Hafezi, Dickens Kowuor, Brian Kohn, Daniel Tindanbil, Kwabena Owusu-Kyei, Muhammed Afolabi, Frank Baiden, Baimba Rogers, Alimamy Serry-Bangura, Agnes Bangura, Tuda Otieno, Daniela Manno, Philip Ayieko, Mohamed Samai, Brett Lowe, Brian Greenwood, and Deborah Watson-Jones

Subjects
Sierra Leone, Ebola, laboratory, laboratory reference values, clinical trial, participant screening, General Works
Abstract

Introduction: The EBOVAC-Salone trial of a candidate Ebola two-dose vaccine regimen (Ad.ZEBOV/MVA-BN-Filo) was conducted in a research-naïve setting in rural northern Sierra Leone, where no local laboratory reference values (LRV) had been established. In the first stage (n = 43) of the trial, laboratory screening was based on internationally-derived protocol LRV (PLRV). For postrecruitment participant care, LRV derived from a West African population (WALRV) were used. We assessed what difference using WALRV rather than PLRV for screening might have made to the eligibility of volunteers. METHODS: We reviewed the laboratory screening results of study volunteers. Red blood cells (RBC), white blood cells (WBC), platelets (PTT), haemoglobin, haematocrit, creatinine, and alanine (ALT) and aspartate (AST) transaminases were measured. Overall and for each parameter, we compared the actually eligible proportion of volunteers using PLRV with the potentially eligible proportion using WALRV. Results: Of 102 (82 males, 20 females) volunteers, overall 55 (53.9% males) met PLRV eligibility criteria for inclusion, compared with 91 (89.2% males) who were within WALRV normal limits (p < 0.0001). Thus, 36 volunteers who failed laboratory screening using PLRV (76.6% of screening failures) might have been eligible if WALRV had been applied. Parameters with significant effect were haemoglobin (33 ineligible by PLRV, vs. 2 ineligible by WALRV; p < 0.0001); RBC (27 vs. 1; p < 0.0001); and PTT (18 vs. 6; p = 0.0093). Levels of creatinine and ALT did not present any differences. Discussion: Use of WALRV in eligibility assessment would potentially have led to considerable differences in the baseline laboratory characteristics of enrolled volunteers. Clinical trials are increasingly common and crucial in emerging infectious disease research. Our findings underscore the importance of locally-derived LRV in clinical trials in sub-Saharan Africa, to avoid excluding potentially eligible study volunteers, and to better support routine clinical care and safety assessments. Appropriately designed studies are needed in each region to establish local LRV.

Published
2020
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