Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT05817422|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2023
Last Update Posted : August 31, 2023
|Condition or disease||Intervention/treatment||Phase|
|Marburg Virus Disease||Biological: cAd3-Marburg vaccine Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10^11 PU dose or placebo at Day 1.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults|
|Estimated Study Start Date :||September 25, 2023|
|Estimated Primary Completion Date :||December 15, 2023|
|Estimated Study Completion Date :||October 31, 2024|
Experimental: cAd3-Marburg vaccine (1.0 × 10^11 PU)
Single dose of cAd3-Marburg vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.
Placebo (0.9% NaCl solution for injection)administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.
Biological: cAd3-Marburg vaccine
The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP) from the Angola strain.
Placebo Comparator: Placebo
Single dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.
0.9% NaCl solution for injection.
- To evaluate the safety and tolerability of cAd3-Marburg vaccine [ Time Frame: 1 year ]
Count and percentage of vaccinated participants who develop:
- serious adverse events (SAEs),
- solicited adverse events (AEs),
- unsolicited AEs,
- adverse event of special interest (AESI),
- medically attended adverse events (MAAE),
- AE at each intensity level.
Estimand 1a (Primary): Count and percentage of vaccinated participants who would develop SAEs, solicited AEs, unsolicited AEs, AESI, MAAE, and AE at each intensity level will be evaluated with each treatment group. A treatment policy strategy is used for assessing safety irrespective of a current (or prior) infection at time of the vaccination. Infections and death (if they meet the AE and time window criteria) are included in the endpoint (composite strategy).
- To evaluate the antibody response (IgG) to cAd3-Marburg vaccine at Day 29 post-vaccination. [ Time Frame: 6 months ]Secondary Endpoint: GMC of anti-Marburg-GP binding IgG antibodies at Day 29 post-vaccination. Estimand 2a: geometric mean concentration (GMC) of the vaccine group will be compared to placebo at Day 29 post-vaccination. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-study vaccines. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05817422
|Contact: Antonio Gonzalez Lopez, MD, PhD, MPHfirstname.lastname@example.org|
|Contact: Norman Waters, PhDemail@example.com|
|KEMRI/Centre for Respiratory Diseases Research Siaya Clinical Research Annex|
|Contact: Videlis Nduba, MD, PhD|
|Makerere University-Walter Reed Project|
|Contact: Betty Mwesigwa, MBChB, MSc.|
|Study Chair:||Antonio Gonzalez Lopez, MD, PhD, MPH||Albert B. Sabin Vaccine Institute|