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| ID | Type | Description | Link |
|---|---|---|---|
| VAC52150EBL2005 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| 2021-001331-10 | EudraCT Number |
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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| University of Sierra Leone | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Ad26.ZEBOV, MVA-BN-Filo | Experimental | Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. Upon completion of the main study, participants in the extension phase who were originally randomized to the control arm will receive the same vaccine regimen as the participants in the Ad26.ZEBOV, MVA-BN-Filo arm of the main study. |
|
| Arm 2: MenACWY | Active Comparator | Participants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.ZEBOV | Biological | Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. | From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8) |
| Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participants participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. | From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64) |
| Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participants in a nondirected manner. | From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29) |
| Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) | Geometric mean of binding antibody levels against the EBOV GP were reported. | 21 days post-dose 2 (Day 78) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National de Formation et de Recherche en Sante Rurale de Maferinyah | Conakry | 2649 | Guinea | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37858585 | Derived | Choi EM, Lacarra B, Afolabi MO, Ale BM, Baiden F, Betard C, Foster J, Hamze B, Schwimmer C, Manno D, D'Ortenzio E, Ishola D, Keita CM, Keshinro B, Njie Y, van Dijck W, Gaddah A, Anumendem D, Lowe B, Vatrinet R, Lawal BJ, Otieno GT, Samai M, Deen GF, Swaray IB, Kamara AB, Kamara MM, Diagne MA, Kowuor D, McLean C, Leigh B, Beavogui AH, Leyssen M, Luhn K, Robinson C, Douoguih M, Greenwood B, Thiebaut R, Watson-Jones D; EBOVAC-3/EBL2005 Study Team. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone. Lancet Glob Health. 2023 Nov;11(11):e1743-e1752. doi: 10.1016/S2214-109X(23)00410-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY | Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| FG001 | Main Study: MenACWY (Control Arm) | Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| FG002 | Extension Study: Ad26.ZEBOV + MVA-BN-Filo | Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study: Up to Day 365 |
|
| |||||||||||||||||||||
| Extension Study: Up to Extension Day 85 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY | Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8) |
|
Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY | Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Lead | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2021 | May 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2021 | May 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C525703 | MenACWY |
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| MVA-BN-Filo | Biological | Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination. |
|
| MenACWY | Biological | Participants will receive 0.5 mL IM injection of MenACWY. |
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner. |
| From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85) |
| Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 6 months post dose-2 on Day 57 (Up to 8 months) |
| Main Study: Percentage of Participants With SAEs Related to Study Intervention | Percentage of participants with SAEs related to study intervention were reported. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Day 365 |
| College of Med and Allied Health Sciences, University of Sierra Leone |
| Freetown |
| Sierra Leone |
| NOT COMPLETED |
|
|
| BG001 | Main Study: MenACWY (Control Arm) | Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| BG002 | Total | Total of all reporting groups |
| months |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
| OG001 | Main Study: MenACWY (Control Arm) | Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. |
|
|
| Primary | Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2 | An AE is any untoward medical occurrence in a participants participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64) |
|
|
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| Primary | Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participants in a nondirected manner. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29) |
|
|
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| Primary | Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85) |
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| Primary | Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57 | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | Up to 6 months post dose-2 on Day 57 (Up to 8 months) |
|
|
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| Secondary | Main Study: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) | Geometric mean of binding antibody levels against the EBOV GP were reported. | The per-protocol immunogenicity population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes (for example, missed Dose 2 vaccination, natural infections, etc.). | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units/milliliter (EU/mL) | 21 days post-dose 2 (Day 78) |
|
|
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| Primary | Main Study: Percentage of Participants With SAEs Related to Study Intervention | Percentage of participants with SAEs related to study intervention were reported. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The full analysis set included all participants with at least one study intervention administration documented. | Posted | Number | Percentage of Participants | Up to Day 365 |
|
|
|
| 0 |
| 75 |
| 10 |
| 75 |
| 58 |
| 75 |
| EG001 | Main Study: MenACWY (Control Arm) | Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237. | 0 | 33 | 4 | 33 | 26 | 33 |
| EG002 | Extension Study: Ad26.ZEBOV+MVA-BN-Filo | Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85. | 0 | 26 | 0 | 26 | 9 | 26 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Gastrointestinal Candidiasis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Measles | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Hypovolaemic Shock | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Acarodermatitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Conjunctivitis Bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Gastrointestinal Candidiasis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Helminthic Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |