A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 263
- Locations
- 9
- Primary Endpoint
- Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
Overview
Brief Summary
The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
Detailed Description
This study was terminated and modifications to the dosing regimens and clinical/laboratory procedures were implemented for trial discontinuation according to Protocol Amendment 04. Per protocol, certain panels were never enrolled and/or the second dose of study intervention was not administered.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Is in overall good health based on medical history, physical examination, electrocardiogram (ECG) and vital sign (VS) measurements performed prior to randomization.
- •Is in overall good health based on laboratory safety tests obtained at the screening visit.
- •Has a body mass index (BMI) \<30 kg/m2 inclusive. On this basis a rounded BMI of 29.9 is acceptable to satisfy the inclusion criteria. BMI = weight (kg)/height (m)
- •Has been practicing social distancing for at least two weeks prior to planned Day 1 vaccination and has no close contacts with known active severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection in that time period.
- •Sentinel trial participants ONLY (Panel A, Panel B, and the first 5 participants of Panel E): Seronegative for SARS-COV-
- •Is male or female, from 18 years to 55 years of age (inclusive) (Parts 1 and 2A) or \>55 years of age (Part 2B), at the time of providing documented informed consent.
- •Male participants are eligible to participate if they agree to refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR agree to use contraception unless confirmed to be azoospermic .
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using an acceptable contraceptive method or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants With at Least One Unsolicited Adverse Event After Any Study Intervention
Time Frame: Up to 28 days after any study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All unsolicited AEs were assessed.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (MAAE)
Time Frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.
Percentage of Participants With at Least One Solicited Systemic AE After Any Study Intervention
Time Frame: Up to 14 days after any study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs of fever, muscle pain, joint pain, headache, fatigue, rash, or nausea were assessed.
Percentage of Participants With at Least 1 Serious Adverse Event
Time Frame: Up to 56 days after vaccination 1 and up to 122 days after vaccination 2 (up to 178 days)
An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event
Time Frame: Up to 57 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants With at Least One Solicited Injection Site Adverse Event (AE) After Any Study Intervention
Time Frame: Up to 5 days after any study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
Secondary Outcomes
- Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)(Days 1, 15, 29, 57, 71, and 85)
- Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Pseudo-virus Neutralization Assay (PNA)(Days 1, 15, 29, 57, 71, and 85)
- Geometric Mean Fold Rise (GMFR) of Total Anti-Spike IgG Antibodies as Measured by ELISA(Days 1, 15, 29, 57, 71, and 85)
- Geometric Mean Fold Rise (GMFR) for Serum nAb as Measured by PNA(Days 1, 15, 29, 57, 71, and 85)