A Phase 1 interventional study of cAd3-Marburg vaccine in Marburg Virus Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study was a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 (cAd3) vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.
A total of 40 participants were evenly split, with 20 in each of the two dosage groups, to receive the investigational cAd3-Marburg 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. Once no safety issues were identified, enrollment of participants into the next dose level 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.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory Criteria within 56 days prior to enrollment:
Female-Specific Criteria:
Exclusion Criteria:
Volunteer has received any of the following substances:
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 conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
Biological: cAd3-Marburg vaccine
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
Biological: cAd3-Marburg vaccine
The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Also known as: VRC-MARADC087-00-VP
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg 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 (FDA Guidance - September 2007).
Time frame: 7 days after study product administration
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg 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 (FDA Guidance - September 2007).The Division of AIDS AE Grading Table Corrected (Version 2.1-July 2017) was used to grade reported events of joint pain (arthralgia).
Time frame: 7 days after study product administration
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
Time frame: 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 FDA Guidance, September 2007 were used.
Time frame: 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.
Time frame: 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.
Time frame: Through 48 weeks after study product administration
Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg 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).
Time frame: Through 28 days after study product administration
Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Vaccine-induced, Ad5-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for Ad5-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).
Time frame: Through 28 days after study product administration
Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration
A positive response occurs if there is a significant increase in the ELISA post vaccination 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.
Time frame: Through 28 days after study product administration
Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration
Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.
Time frame: Through 28 days after study product administration
Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg 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.
Time frame: Through 28 days after study product administration
Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
Median and interquartile ranges presented for total cytokine responses for both CD4 and CD8 memory T cells based on a T cell response with any cytokine at Week 4 for each dose group.
Time frame: Through 28 days after study product administration
Healthy adults were recruited at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, Maryland, USA.
| Milestone | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Started | 20 | 20 |
| Received product administration | 20 | 20 |
| Completed | 20 | 17 |
| Not completed | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Moved from area | 0 | 2 |
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 (FDA Guidance - September 2007).
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| Pain — None | 9 | 4 | 13 |
| Pain — Mild | 10 | 12 | 22 |
| Pain — Moderate | 1 | 4 | 5 |
| Pain — Severe | 0 | 0 | 0 |
| Swelling — None | 20 | 20 | 40 |
| Swelling — Mild | 0 | 0 | 0 |
| Swelling — Moderate | 0 | 0 | 0 |
| Swelling — Severe | 0 | 0 | 0 |
| Redness — None | 20 | 20 | 40 |
| Redness — Mild | 0 | 0 | 0 |
| Redness — Moderate | 0 | 0 | 0 |
| Redness — Severe | 0 | 0 | 0 |
| Any Local Symptom — None | 9 | 4 | 13 |
| Any Local Symptom — Mild | 10 | 12 | 22 |
| Any Local Symptom — Moderate | 1 | 4 | 5 |
| Any Local Symptom — Severe | 0 | 0 | 0 |
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 (FDA Guidance - September 2007).The Division of AIDS AE Grading Table Corrected (Version 2.1-July 2017) was used to grade reported events of joint pain (arthralgia).
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| Unusually Tired/Feeling Unwell (Malaise) — None | 15 | 7 | 22 |
| Unusually Tired/Feeling Unwell (Malaise) — Mild | 2 | 11 | 13 |
| Unusually Tired/Feeling Unwell (Malaise) — Moderate | 3 | 2 | 5 |
| Unusually Tired/Feeling Unwell (Malaise) — Severe | 0 | 0 | 0 |
| Muscle Aches (Myalgia) — None | 15 | 11 | 26 |
| Muscle Aches (Myalgia) — Mild | 5 | 6 | 11 |
| Muscle Aches (Myalgia) — Moderate | 0 | 3 | 3 |
| Muscle Aches (Myalgia) — Severe | 0 | 0 | 0 |
| Headache — None | 14 | 9 | 23 |
| Headache — Mild | 4 | 8 | 12 |
| Headache — Moderate | 2 | 3 | 5 |
| Headache — Severe | 0 | 0 | 0 |
| Chills — None | 17 | 14 | 31 |
| Chills — Mild | 3 | 0 | 3 |
| Chills — Moderate | 0 | 6 | 6 |
| Chills — Severe | 0 | 0 | 0 |
| Nausea — None | 18 | 18 | 36 |
| Nausea — Mild | 2 | 2 | 4 |
| Nausea — Moderate | 0 | 0 | 0 |
| Nausea — Severe | 0 | 0 | 0 |
| Temperature (Fever) — None | 20 | 17 | 37 |
| Temperature (Fever) — Mild | 0 | 2 | 2 |
| Temperature (Fever) — Moderate | 0 | 0 | 0 |
| Temperature (Fever) — Severe | 0 | 1 | 1 |
| Arthralgia — None | 18 | 13 | 31 |
| Arthralgia — Mild | 2 | 5 | 7 |
| Arthralgia — Moderate | 0 | 2 | 2 |
| Arthralgia — Severe | 0 | 0 | 0 |
| Any Systemic Symptom — None | 10 | 3 | 13 |
| Any Systemic Symptom — Mild | 5 | 10 | 15 |
| Any Systemic Symptom — Moderate | 5 | 6 | 11 |
| Any Systemic Symptom — Severe | 0 | 1 | 1 |
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| Total Number of Participants who had Any Local Reactogenicity Signs and Symptoms | 11 | 16 | 27 |
| Total Number of Participants who had Any Systemic Reactogenicity Signs and Symptoms | 10 | 17 | 27 |
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 FDA Guidance, September 2007 were used.
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| ALT | 1 | 0 | 1 |
| WBC Count | 0 | 4 | 4 |
| Hemoglobin | 2 | 4 | 6 |
| Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 3 | 8 | 11 |
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.
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| Related to Study Product | 0 | 5 | 5 |
| Unrelated to Study Product | 6 | 11 | 17 |
| Total Number of Participants who had One or More Non-Serious Unsolicited AE | 6 | 16 | 22 |
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.
| Participants | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU) |
|---|---|---|---|
| Related to Study Product | 0 | 0 | 0 |
| Unrelated to Study Product | 2 | 0 | 2 |
| Total Number of Participants who had an SAE | 2 | 0 | 2 |
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).
| 90% inhibitory concentration(IC90)titer | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Week 0 (Baseline, Pre-Administration) | 49.3 (27.0 to 89.9) | 48.8 (22.9 to 89.9) |
| Week 4 (28 Days After Product Administration) | 414.6 (232.6 to 739.0) | 437.1 (255.8 to 746.8) |
Vaccine-induced, Ad5-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for Ad5-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).
| 90% inhibitory concentration(IC90)titer | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Week 0 (Baseline, Pre-Administration) | 101.1 (25.7 to 396.8) | 224.2 (61.0 to 396.8) |
| Week 4 (28 Days after Product Administration) | 181.6 (50.7 to 650.2) | 405.1 (116.6 to 1407.4) |
A positive response occurs if there is a significant increase in the ELISA post vaccination 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.
| Percentage of responders | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration | 95 (75 to 100) | 95 (75 to 100) |
Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.
| titer | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration | 420.78 (209.30 to 845.98) | 545.11 (275.63 to 1078.07) |
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.
| Percentage of responders | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Percentage of Participants who produced at least one CD4 cytokine | 70 (46 to 88) | 95 (75 to 100) |
| Percentage of Participants who produced at least one CD8 cytokine | 30 (12 to 54) | 20 (6 to 44) |
Median and interquartile ranges presented for total cytokine responses for both CD4 and CD8 memory T cells based on a T cell response with any cytokine at Week 4 for each dose group.
| percent of subset | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| CD4 | 0.10 (0.07 to 0.16) | 0.11 (0.08 to 0.13) |
| CD8 | 0.08 (0.05 to 0.25) | 0.11 (0.08 to 0.21) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | 0/20 (0%) | 2/20 (10%) | 11/20 (55%) |
| Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | 0/20 (0%) | 0/20 (0%) | 16/20 (80%) |
| Event | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Staphylococcal infectionInfections and infestations | 1/20 | 0/20 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/20 | 0/20 |
| Event | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) |
|---|---|---|
| Administration site painGeneral disorders | 11/20 | 16/20 |
| MalaiseGeneral disorders | 5/20 | 13/20 |
| HeadacheNervous system disorders | 6/20 | 11/20 |
| MyalgiaMusculoskeletal and connective tissue disorders | 5/20 | 9/20 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/20 | 7/20 |
| ChillsGeneral disorders | 3/20 | 6/20 |
| AnaemiaBlood and lymphatic system disorders | 2/20 | 4/20 |
| Upper Respiratory Tract InfectionInfections and infestations | 1/20 | 4/20 |
| PyrexiaGeneral disorders | 0/20 | 3/20 |
| NauseaGastrointestinal disorders | 2/20 | 2/20 |
Population includes all enrolled participants.
| Age, Customized(Participants) | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Total |
|---|---|---|---|
| 18-20 years | 1 | 0 | 1 |
| 21-30 years | 4 | 7 | 11 |
| 31-40 years | 7 | 8 | 15 |
| 41-50 years | 8 | 5 | 13 |
| Sex: Female, Male(Participants) | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Total |
|---|---|---|---|
| Female | 12 | 13 | 25 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 18 | 16 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 10 | 4 | 14 |
| White | 7 | 11 | 18 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(Participants) | Group 1: cAd3-Marburg Vaccine (1x10^10 PU) | Group 2: cAd3-Marburg Vaccine (1x10^11 PU) | Total |
|---|---|---|---|
| 18.5-24.9 kg/m^2 | 6 | 8 | 14 |
| 25.0-29.9 kg/m^2 | 10 | 7 | 17 |
| 30.0-40.0 kg/m^2 | 4 | 5 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Dec 2019, 14 months.
Results were first posted in Jan 2021, 1 year after primary completion.
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Marburg Virus Disease
National Institute of Allergy and Infectious Diseases (NIAID) →