Ebola VirusPhase 1NCT04041570

Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults

A Phase 1 study testing cAd3-EBO S vaccine in people with Ebola Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults. VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype 3 vector-based Ebola vaccine, encodes wild type (WT) glycoprotein (GP) from the Sudan strain of… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Ebola Virus
What is being tested?: cAd3-EBO S vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUganda
Study dates: 2 Jul 2019to 7 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 to 50 years old.
Available for clinical follow-up through Week 48 after enrollment.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Able and willing to provide fingerprints and have their photographs taken including injection site photographs.
Must allow home visits
Must complete an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts.

Show all 20Show fewer

Able to read (English or Luganda) and willing to complete the informed consent process.
In good general health without clinically significant medical history.
Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≤ 40 within the 56 days prior to enrollment.
Laboratory Criteria within 56 days prior to enrollment:
Hemoglobin ≥ 11.0 g/dL for women; ≥12.5 g/dL for men.
White blood cells (WBC) = 2,500-12,000 cells/mm^3.
Total lymphocyte count ≥ 800 cells/mm^3.
Platelets = 125,000 - 400,000/mm^3.
Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal.
Serum creatinine ≤ 1 x upper limit of normal.
HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic test.
Female-Specific Criteria:
Negative β-HCG (human chorionic gonadotropin) pregnancy test; serum β-HCG at screening and urine β-HCG at enrollment if woman is of reproductive potential.
Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if assessed to be of reproductive potential.

Who cannot join

Volunteer has received any of the following substances:
Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator's discretion.
Blood products within 112 days (16 weeks) prior to enrollment.
Investigational research agents within 28 days (4 weeks) prior to enrollment.
Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.

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Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
Current anti-tuberculosis prophylaxis or therapy.
Female-specific criteria:
Woman who is pregnant, breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.
Volunteer has a history of any of the following clinically significant conditions:
Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
Allergic reaction to excipients in the study vaccine including gentamycin, neomycin or streptomycin.
Clinically significant autoimmune disease or immunodeficiency.
Asthma that is not well controlled.
Positive result on a rapid plasma reagin (RPR) test.
Diabetes mellitus (type I or II).
Thyroid disease that is not well controlled.
A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
Idiopathic urticaria within the last 1 year.
Hypertension that is not well controlled.
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
A malignancy that is active, currently being treated, or not surgically cured.
Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
Asplenia or functional asplenia.
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within five years prior to enrollment, history of a suicide plan or attempt.
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Makerere University-Walter Reed Project
Kampala

Other trials in Uganda

About this study

Official title: A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of an Ebola Sudan Chimpanzee Adenovirus Vector Vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), in Healthy Adults

Read the detailed description

A total of 40 participants were evenly split, with 20 in each of the two dosage groups to receive the investigational cAd3-EBO S vaccine at a dose of either 1x10^10 particle units (PU) (Group 1) or 1x10^11 PU (Group 2). The dose escalation plan included daily review of any new safety data by a study clinician, regular review of safety data by the protocol team and a staged enrollment plan with required interim safety reviews. The study began with enrollment of 3 participants into Group 1 (1x10^10 PU) at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety review occurred before enrollment of additional participants into the group. No safety issues were identified; therefore, an additional 17 participants were enrolled to complete Group 1. When there was a minimum of seven days of follow-up safety data from the last enrolled participant in Group 1, an interim safety review occurred. No safety issues were identified, and enrollment of participants into the next dose level (Group 2) began with the enrollment of 3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants in Group 2 (1x10^11 PU), an interim safety review occurred before the enrollment of additional participants into Group 2. No safety issues were identified, and an additional 17 participants were enrolled to complete Group 2. Participants were followed for approximately 48 weeks.

Conditions: Ebola Virus
Being tested: cAd3-EBO S vaccine
Keywords: Ebola virus, Ebola vaccine, cAd3-EBO S

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cAd3-EBO S vaccineBiological
Also called VRC-EBOADC086-00-VP
The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP).

Study groups in NCT04041570
Study group	Role	What they receive
Group 1: cAd3-EBO S vaccine (1x10^10 PU)	Experimental	cAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL Receives: Biological: cAd3-EBO S vaccine
Group 2: cAd3-EBO S vaccine (1x10^11 PU)	Experimental	cAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL Receives: Biological: cAd3-EBO S vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Measured: 7 days after study product administration
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. The majority of the reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. The Division of AIDS AE Grading Table, Corrected Version 2.1 was used to grade reported events of joint pain (arthralgia).
Measured: 7 days after study product administration
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
Measured: 7 days after study product administration
Number of Participants With Abnormal Laboratory Measures of Safety
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hemoglobin change from baseline, hematocrit percent, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC) and lymphocyte counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with total lymphocyte count results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), Day 3, and Weeks 2, 4, 8 and 24. Creatinine and ALT results were collected at screening, Day 0, Day 3 and Weeks 2, 4 and 8. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials, modified from FDA Guidance-September 2007 were used. Neutrophil results were not collected in the study database but were captured in the subject's laboratory results documentation.
Measured: Through 48 weeks after study product administration
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Through 28 days after study product administration
Number of Participants With Serious Adverse Events (SAEs)
SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Through 48 weeks after study product administration

Secondary outcomes (5)

Geometric Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-EBO S Vaccine Administration
Vaccine-induced, cAd3-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for cAd3-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).
Measured: Through 28 days after study product administration
Percentage of Participants With a Positive Ebola-Specific Antibody Response After the cAd3-EBO S Vaccine Administration
A positive response is defined as a significant increase in the ELISA titer post vaccination (Week 4) compared to baseline. For each participant, a t-test was performed to compare the post vaccination titers versus those at baseline. A participant is defined as a positive responder if the one-sided t-test has a p-value < 0.05.
Measured: Through 28 days after study product administration
Baseline-subtracted Geometric Mean Titers of cAd3-EBO S Antibodies After the cAd3-EBO S Vaccine Administration
Baseline (Day 0)-subtracted geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.
Measured: Through 28 days after study product administration
Percentage of Participants With Positive Ebola-specific T Cell Responses After the cAd3-EBO S Vaccine Administration
T cell response was measured by Intracellular Cytokine Staining (ICS) assays using Peripheral Blood Mononuclear Cells (PBMCs) at 4 weeks after vaccination. The percentage of participants with T cell responses with Clopper-Pearson 95% Confidence Intervals are presented. Positivity is defined as a response over calculated thresholds determined by the trial statistician.
Measured: Through 28 days after study product administration
Magnitude of T Cell Response as a Percentage of EBO S-specific T Cell Subset After the cAd3-EBO S Vaccine Administration
Median and interquartile ranges presented for percentage of EBO S-specific CD4 and CD8 memory T cells based on cytokine production at Week 4 for each dose group.
Measured: Through 28 days after study product administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20197 Sep 2020

First posted1 Aug 2019
Study start2 Jul 2019
Primary completion7 Sep 2020
Study completion7 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Ebola VirusStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Model description: Sequential Assignment Dose Escalation
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04041570
Sponsor's protocol ID: RV 508
Other IDs: WRAIR 2439
Status last verified: Nov 2022
First submitted: 25 Jul 2019
Last updated: 6 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.
PubMed 25225676
Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
PubMed 25540891
Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine. N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.
PubMed 25426834
Paris R, Kuschner RA, Binn L, Thomas SJ, Colloca S, Nicosia A, Cortese R, Bailer RT, Sullivan N, Koup RA. Adenovirus type 4 and 7 vaccination or adenovirus type 4 respiratory infection elicits minimal cross-reactive antibody responses to nonhuman adenovirus vaccine vectors. Clin Vaccine Immunol. 2014 May;21(5):783-6. doi: 10.1128/CVI.00011-14. Epub 2014 Mar 12.
PubMed 24623627
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
US Food and Drug Administration. Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. September 2007. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical
Mwesigwa B, Houser KV, Hofstetter AR, Ortega-Villa AM, Naluyima P, Kiweewa F, Nakabuye I, Yamshchikov GV, Andrews C, O'Callahan M, Strom L, Schech S, Anne Eller L, Sondergaard EL, Scott PT, Amare MF, Modjarrad K, Wamala A, Tindikahwa A, Musingye E, Nanyondo J, Gaudinski MR, Gordon IJ, Holman LA, Saunders JG, Costner PJM, Mendoza FH, Happe M, Morgan P, Plummer SH, Hickman SP, Vazquez S, Murray T, Cordon J, Dulan CNM, Hunegnaw R, Basappa M, Padilla M, Gajjala SR, Swanson PA 2nd, Lin BC, Coates EE, Gall JG, McDermott AB, Koup RA, Mascola JR, Ploquin A, Sullivan NJ, Kibuuka H, Ake JA, Ledgerwood JE; RV 508 Study Team. 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. Lancet Infect Dis. 2023 Dec;23(12):1408-1417. doi: 10.1016/S1473-3099(23)00344-4. Epub 2023 Aug 3.
PubMed 37544326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of an Ebola Sudan Chimpanzee Adenovirus Vector Vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), in Healthy Adults
ClinicalTrials.gov ID: NCT04041570
Acronym / sponsor ID: RV 508
Conditions: Ebola Virus
Keywords: Ebola virus, Ebola vaccine, cAd3-EBO S
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: US Military HIV Research Program
Study start: 2 Jul 2019 (actual)
Primary completion: 7 Sep 2020 (actual)
Study completion: 7 Sep 2020 (actual)
First posted: 1 Aug 2019 (actual)
Results: Posted 24 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Sequential Assignment Dose Escalation

Arm	Type	Receives
Group 1: cAd3-EBO S vaccine (1x10^10 PU)	Experimental	Biological: cAd3-EBO S vaccinecAd3-EBO S vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
Group 2: cAd3-EBO S vaccine (1x10^11 PU)	Experimental	Biological: cAd3-EBO S vaccinecAd3-EBO S vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

18 to 50 years old.
Available for clinical follow-up through Week 48 after enrollment.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Able and willing to provide fingerprints and have their photographs taken including injection site photographs.
Must allow home visits

Key exclusion criteria (27 listed)

Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator's discretion.
Blood products within 112 days (16 weeks) prior to enrollment.
Investigational research agents within 28 days (4 weeks) prior to enrollment.
Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cAd3-EBO S vaccineAlso: VRC-EBOADC086-00-VPThe recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), is composed of a cAd3 vector that encodes Ebola Sudan wild type glycoprotein (WT GP).	Biological	Group 1: cAd3-EBO S vaccine (1x10^10 PU), Group 2: cAd3-EBO S vaccine (1x10^11 PU)

Primary outcome

Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Time frame: 7 days after study product administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Time frame: 7 days after study product administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. The majority of the reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. The Division of AIDS AE Grading Table, Corrected Version 2.1 was used to grade reported events of joint pain (arthralgia).
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration
Time frame: 7 days after study product administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
Number of Participants With Abnormal Laboratory Measures of Safety
Time frame: Through 48 weeks after study product administration
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hemoglobin change from baseline, hematocrit percent, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC) and lymphocyte counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with total lymphocyte count results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), Day 3, and Weeks 2, 4, 8 and 24. Creatinine and ALT results were collected at screening, Day 0, Day 3 and Weeks 2, 4 and 8. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials, modified from FDA Guidance-September 2007 were used. Neutrophil results were not collected in the study database but were captured in the subject's laboratory results documentation.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Time frame: Through 28 days after study product administration
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Through 48 weeks after study product administration
SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

5 secondary outcomes

Geometric Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-EBO S Vaccine Administration
Time frame: Through 28 days after study product administration
Percentage of Participants With a Positive Ebola-Specific Antibody Response After the cAd3-EBO S Vaccine Administration
Time frame: Through 28 days after study product administration
Baseline-subtracted Geometric Mean Titers of cAd3-EBO S Antibodies After the cAd3-EBO S Vaccine Administration
Time frame: Through 28 days after study product administration
Percentage of Participants With Positive Ebola-specific T Cell Responses After the cAd3-EBO S Vaccine Administration
Time frame: Through 28 days after study product administration
Magnitude of T Cell Response as a Percentage of EBO S-specific T Cell Subset After the cAd3-EBO S Vaccine Administration
Time frame: Through 28 days after study product administration

Results and safety

Results posted to the registry on 24 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: cAd3-EBO S Vaccine (1x10^10 PU)	20	20
Group 2: cAd3-EBO S Vaccine (1x10^11 PU)	20	18

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration

Time frame: 7 days after study product administration. Count of participants. Unit: Participants

Measure	Group 1: cAd3-EBO S Vaccine (1x10^10 PU) n = 20	Group 2: cAd3-EBO S Vaccine (1x10^11 PU) n = 20	Overall Incidence cAd3-EBO S Vaccine (1x10^10 PU and 1x10^11 PU) n = 40
Pain: None	3	3	6
Pain: Mild	16	9	25
Pain: Moderate	1	8	9
Pain: Severe	0	0	0
Swelling: None	20	16	36
Swelling: Mild	0	3	3
Swelling: Moderate	0	1	1
Swelling: Severe	0	0	0

Population analysed: All participants who received the cAd3-EBO S vaccine.

Primary outcome: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration

Time frame: 7 days after study product administration. Count of participants. Unit: Participants

Measure	Group 1: cAd3-EBO S Vaccine (1x10^10 PU) n = 20	Group 2: cAd3-EBO S Vaccine (1x10^11 PU) n = 20	Overall Incidence cAd3-EBO S Vaccine (1x10^10 PU and 1x10^11 PU) n = 40
Unusually Tired/Feeling Unwell (Malaise): None	9	2	11
Unusually Tired/Feeling Unwell (Malaise): Mild	9	8	17
Unusually Tired/Feeling Unwell (Malaise): Moderate	2	10	12
Unusually Tired/Feeling Unwell (Malaise): Severe	0	0	0
Muscle Aches (Myalgia): None	15	13	28
Muscle Aches (Myalgia): Mild	5	5	10
Muscle Aches (Myalgia): Moderate	0	2	2
Muscle Aches (Myalgia): Severe	0	0	0

Population analysed: All participants who received the cAd3-EBO S vaccine.

Primary outcome: Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration

Time frame: 7 days after study product administration. Count of participants. Unit: Participants

Measure	Group 1: cAd3-EBO S Vaccine (1x10^10 PU) n = 20	Group 2: cAd3-EBO S Vaccine (1x10^11 PU) n = 20	Overall Incidence cAd3-EBO S Vaccine (1x10^10 PU and 1x10^11 PU) n = 40
Total Number of Participants who had Any Local Reactogenicity Signs and Symptoms	17	18	35
Total Number of Participants who had Any Systemic Reactogenicity Signs and Symptoms	16	19	35

Population analysed: All participants who received the cAd3-EBO S vaccine.

Primary outcome: Number of Participants With Abnormal Laboratory Measures of Safety

Time frame: Through 48 weeks after study product administration. Count of participants. Unit: Participants

Measure	Group 1: cAd3-EBO S Vaccine (1x10^10 PU) n = 20	Group 2: cAd3-EBO S Vaccine (1x10^11 PU) n = 20	Overall Incidence cAd3-EBO S Vaccine (1x10^10 PU and 1x10^11 PU) n = 40
ALT	1	1	2
WBC Count	1	1	2
Neutrophil Count	1	2	3
Hemoglobin	0	0	0
Hemoglobin change from baseline	0	0	0
Hematocrit percent	0	0	0
Mean corpuscular volume (MCV)	0	0	0
Platelets	0	0	0

Population analysed: All participants who received the cAd3-EBO S vaccine.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: cAd3-EBO S Vaccine (1x10^10 PU)	0 of 20 (0%)	19 of 20 (95%)	0 of 20
Group 2: cAd3-EBO S Vaccine (1x10^11 PU)	0 of 20 (0%)	19 of 20 (95%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25225676Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.
Background: PubMed 25540891Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
Background: PubMed 25426834Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine. N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.
Background: PubMed 24623627Paris R, Kuschner RA, Binn L, Thomas SJ, Colloca S, Nicosia A, Cortese R, Bailer RT, Sullivan N, Koup RA. Adenovirus type 4 and 7 vaccination or adenovirus type 4 respiratory infection elicits minimal cross-reactive antibody responses to nonhuman adenovirus vaccine vectors. Clin Vaccine Immunol. 2014 May;21(5):783-6. doi: 10.1128/CVI.00011-14. Epub 2014 Mar 12.
BackgroundU.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
BackgroundUS Food and Drug Administration. Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. September 2007. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical
Derived from this study: PubMed 37544326Mwesigwa B, Houser KV, Hofstetter AR, Ortega-Villa AM, Naluyima P, Kiweewa F, Nakabuye I, Yamshchikov GV, Andrews C, O'Callahan M, Strom L, Schech S, Anne Eller L, Sondergaard EL, Scott PT, Amare MF, Modjarrad K, Wamala A, Tindikahwa A, Musingye E, Nanyondo J, Gaudinski MR, Gordon IJ, Holman LA, Saunders JG, Costner PJM, Mendoza FH, Happe M, Morgan P, Plummer SH, Hickman SP, Vazquez S, Murray T, Cordon J, Dulan CNM, Hunegnaw R, Basappa M, Padilla M, Gajjala SR, Swanson PA 2nd, Lin BC, Coates EE, Gall JG, McDermott AB, Koup RA, Mascola JR, Ploquin A, Sullivan NJ, Kibuuka H, Ake JA, Ledgerwood JE; RV 508 Study Team. 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. Lancet Infect Dis. 2023 Dec;23(12):1408-1417. doi: 10.1016/S1473-3099(23)00344-4. Epub 2023 Aug 3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cAd3-EBO S vaccine in people with Ebola Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration (time frame: 7 days after study product administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04041570, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.