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
Overview
- Phase
- Phase 2
- Intervention
- cAd3-Marburg vaccine
- Conditions
- Marburg Virus Disease
- Sponsor
- Albert B. Sabin Vaccine Institute
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- To evaluate the safety and tolerability of cAd3-Marburg vaccine
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
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
Detailed Description
This is a multi-center, double-blinded, placebo-controlled, Phase II study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg vaccine in healthy adults up to 70 years of age, in Uganda and Kenya. The study will enroll 125 eligible participants randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10\^11 PU dose or placebo (0.9% sodium chloride (NaCl) solution) at Day 1, intramuscularly in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Enrollment will be staggered, starting with healthy adults 18 to 50 years of age (inclusive). Upon enrollment of minimum 25 younger adult participants (sentinel), the safety data up to 7 days post vaccination of these 25 sentinel participants will be reviewed by the independent DSMB. Progression to enrollment of the older adults (\>50 to 70 years of age) will be dependent on the unblinded review of the Data Safety Monitoring Board (DSMB). Safety and immunogenicity will be assessed at Days 1, 8, 15, 29, 85, 169, and will conclude at the end of study visit on Day 366.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able and willing to complete and provide written informed consent prior to any study procedure; including injection site photograph consent, completing an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions correctly at least once in 3 attempts, and including optional consent for retention of blood samples for potential future testing and assay development.
- •Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development.
- •Able to read and write the language used in diary card.
- •Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informed consent.
- •Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits.
- •Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- •Has a means to be contacted and to contact the investigator during the study.
- •Agree not to receive any vaccine within 28 days from study vaccination (prior and after), with the exception of an emergency use authorization or authorized non-adenoviral vectored coronavirus disease 2019 (COVID-19) vaccine, which may be given within 14 days of study vaccination.
- •Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination.
- •In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by the principal investigator.
Exclusion Criteria
- •Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
- •Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that
- •would place the participant at an unacceptable risk of injury,
- •render the participant unable to comply with the requirements of the protocol,
- •or may interfere with the evaluation of responses or the participant's successful completion of the trial; (chronic conditions that are well-controlled and medically stable, ie, no change in treatment for medical reasons occurred in the last 6 months, are allowed at the discretion of the principal investigator, eg, hypertension, asthma, thyroid disease).
- •The medical disease or condition also includes any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- •Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1 and 2, syphilis).
- •Known prior exposure to MARV or prior diagnosis of Marburg virus disease (MVD).
- •Current diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) or antigenic testing or current signs and symptoms of COVID-
- •Participants may be enrolled 14 days post resolution of all signs and symptoms of COVID-19 or of testing positive for COVID-19 in asymptomatic participants.
Arms & Interventions
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.
Intervention: cAd3-Marburg vaccine
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.
Intervention: Placebo
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- To evaluate the antibody response (IgG) to cAd3-Marburg vaccine at Day 29 post-vaccination.(6 months)