NCT03475056 is a Phase 1 clinical trial of cAd3-Marburg vaccine in Marburg Virus Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT03475056?

NCT03475056 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT03475056?

Interventions in NCT03475056: cAd3-Marburg vaccine.

What condition does NCT03475056 study?

NCT03475056 studies Marburg Virus Disease.

Is NCT03475056 still recruiting?

NCT03475056 is currently completed. Last updated 11 August 2022.

Are results published for NCT03475056?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-11 · How we verify

NCT03475056

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

cAd3-Marburg Vaccine in Healthy Adults

Completed Phase 1 Results posted Last updated 11 August 2022

What this trial tests

Phase 1 trial testing cAd3-Marburg vaccine in Marburg Virus Disease in 40 participants. Completed in 19 December 2019.

Timeline

9 October 2018

Primary endpoint
19 December 2019

19 December 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	9 October 2018
Primary completion	19 December 2019
Estimated completion	19 December 2019
Sites	1 location across United States

Drugs / interventions tested

cAd3-Marburg vaccine — full drug profile →

Conditions studied

Marburg Virus Disease — all drugs for Marburg Virus Disease →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Marburg Virus Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration Primary · 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 Adu

Pain

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	9
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	13
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	10
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	12
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	22
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	1
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	5
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Swelling

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	20
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	20
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	40
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Redness

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	20
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	20
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	40
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Any Local Symptom

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	9
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	13
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	10
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	12
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	22
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	1
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	5
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration Primary · 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 Gra

Unusually Tired/Feeling Unwell (Malaise)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	15
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	7
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	22
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	11
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	13
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	3
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	2
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	5
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Muscle Aches (Myalgia)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	15
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	11
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	26
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	5
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	6
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	11
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	3
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	3
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Headache

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	14
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	9
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	23
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	4
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	8
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	12
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	3
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	5
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Chills

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	17
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	14
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	31
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	3
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	3
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	6
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	6
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Nausea

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	18
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	18
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	36
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	2
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	4
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Temperature (Fever)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	20
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	17
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	37
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	2
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	2
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	1
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	1

Arthralgia

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	18
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	13
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	31
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	5
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	7
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	2
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	2
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Any Systemic Symptom

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	10
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	3
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	13
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	5
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	10
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	15
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	5
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	6
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	11
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	1
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	1

Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration Primary · 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.

Total Number of Participants who had Any Local Reactogenicity Signs and Symptoms

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	11
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	16
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	27

Total Number of Participants who had Any Systemic Reactogenicity Signs and Symptoms

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	10
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	17
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	27

Number of Participants With Abnormal Laboratory Measures of Safety Primary · 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

ALT

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	1
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	1

WBC Count

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	4

Hemoglobin

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	4
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	6

Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	3
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	8
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	11

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Primary · 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 an

Related to Study Product

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	5
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	5

Unrelated to Study Product

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	6
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	11
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	17

Total Number of Participants who had One or More Non-Serious Unsolicited AE

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	6
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	16
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	22

Number of Participants With Serious Adverse Events (SAEs) Primary · 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.

Related to Study Product

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	0

Unrelated to Study Product

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	2

Total Number of Participants who had an SAE

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)	2

Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product 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).

Week 0 (Baseline, Pre-Administration)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	49.3	27.0 – 89.9
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	48.8	22.9 – 89.9

Week 4 (28 Days After Product Administration)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	414.6	232.6 – 739.0
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	437.1	255.8 – 746.8

Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product 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).

Week 0 (Baseline, Pre-Administration)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	101.1	25.7 – 396.8
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	224.2	61.0 – 396.8

Week 4 (28 Days after Product Administration)

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	181.6	50.7 – 650.2
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	405.1	116.6 – 1407.4

Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product 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.

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	95	75 – 100
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	95	75 – 100

Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product administration

Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	420.78	209.30 – 845.98
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	545.11	275.63 – 1078.07

Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product 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.

Percentage of Participants who produced at least one CD4 cytokine

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	70	46 – 88
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	95	75 – 100

Percentage of Participants who produced at least one CD8 cytokine

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	30	12 – 54
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	20	6 – 44

Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration Secondary · Through 28 days after study product 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.

CD4

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0.10	0.07 – 0.16
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0.11	0.08 – 0.13

CD8

Group	Value	95% CI
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	0.08	0.05 – 0.25
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	0.11	0.08 – 0.21

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: cAd3-Marburg Vaccine (1x10^10 PU)

Serious: 2/20 (10%)

Deaths: 0/20

Group 2: cAd3-Marburg Vaccine (1x10^11 PU)

Serious: 0/20 (0%)

Deaths: 0/20

Serious adverse events (2 terms)

Reaction	System	Group 1: cAd3-Marburg Vacc…	Group 2: cAd3-Marburg Vacc…
Staphylococcal infection	Infections and infestations	—	—
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Group 1: cAd3-Marburg Vacc…	Group 2: cAd3-Marburg Vacc…
Administration site pain	General disorders	—	—
Malaise	General disorders	—	—
Headache	Nervous system disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Chills	General disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Tachycardia	Cardiac disorders	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Lymph Node Pain	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Foreign Body Reaction	General disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Wrist Fracture	Injury, poisoning and procedural complications	—	—
Alanine Aminotransferase Increased	Investigations	—	—
Headache	Nervous system disorders	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Staphylococcal infection, Breast Cancer.

Data from ClinicalTrials.gov NCT03475056 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Viral Emerging Diseases: Challenges in Developing Vaccination Strategies.
Trovato M, Sartorius R, D'Apice L, Manco R, et al · · 2020 · cited 87× · PMID 33013898 · DOI 10.3389/fimmu.2020.02130
Marburg virus disease: A summary for clinicians.
Kortepeter MG, Dierberg K, Shenoy ES, Cieslak TJ, et al · · 2020 · cited 81× · PMID 32758690 · DOI 10.1016/j.ijid.2020.07.042
Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial.
Hamer MJ, Houser KV, Hofstetter AR, Ortega-Villa AM, et al · · 2023 · cited 51× · PMID 36709074 · DOI 10.1016/s0140-6736(22)02400-x
Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
Filovirus vaccines as a response paradigm for emerging infectious diseases.
Marzi A, Feldmann H. · · 2024 · cited 15× · PMID 39394249 · DOI 10.1038/s41541-024-00985-y
Lessons learned from Zaire ebolavirus to help address urgent needs for vaccines against Sudan ebolavirus and Marburg virus.
Wolfe DN, Taylor MJ, Zarrabian AG. · · 2020 · cited 8× · PMID 32275465 · DOI 10.1080/21645515.2020.1741313
Emerging Strategies and Progress in the Medical Management of Marburg Virus Disease.
Musafiri S, Siddig EE, Nkuranga JB, Rukundo A, et al · · 2025 · cited 3× · PMID 40333077 · DOI 10.3390/pathogens14040322

Verify or expand the search:

Other trials of cAd3-Marburg vaccine

Trials testing the same drug.

NCT05817422 — Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults · Phase 2 · completed

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03475056 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 11 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03475056.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing