Status:
COMPLETED
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndr...
Detailed Description
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndr...
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria to be eligible to participate in this study:
- Individuals \>/= 18 years of age at the time of consent.
- Received and completed primary mRNA COVID-19 vaccine under EUA dosing guidelines and one or two doses of Ad26.COV2.S at least 12 weeks prior to enrollment (Cohort 1 only).
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
- Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health.\*
- \* Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
- Female participants of childbearing potential may be enrolled in the study, if all of the following apply:
- Practiced adequate contraception for 28 days prior to the first dose of vaccine (Day 1),
- Has agreed to continue adequate contraception through 3 months following the booster dose,
- Has a negative pregnancy test at screening and on the day of the first study vaccine dose (Day 1),
- Is not currently breastfeeding.
Exclusion
- Participants meeting any of the following criteria will be excluded from the study:
- Known history of SARS-CoV-2 infection. (for Cohort 1 and the primary series of Cohort 2).
- Prior administration of an investigational coronavirus (SARS Coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV)) vaccine or SARS Coronavirus 2 (SARS-CoV-2) monoclonal antibody in the preceding 90 days or current/planned simultaneous participation in another interventional study.
- Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2 only).
- A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles.
- Receipt of any investigational study product within 28 days prior to enrollment.
- Received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws, or previously experienced thrombosis with thrombocytopenia (TTS) or heparin-induced thrombocytopenia.
- Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition.
- Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids \>/= 20 milligram per day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Day 1.
- Received immunoglobulin, blood-derived products, within 90 days prior to first study vaccination.
- An immediate family member or household member of this study's personnel.
- Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as \>/= 38.0 degrees Celsius or 100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2023
Estimated Enrollment :
867 Patients enrolled
Trial Details
Trial ID
NCT04889209
Start Date
May 28 2021
End Date
June 16 2023
Last Update
April 20 2025
Active Locations (10)
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1
The Hope Clinic of Emory University
Decatur, Georgia, United States, 30030-1705
2
University of Maryland Baltimore - Institute of Human Virology
Baltimore, Maryland, United States, 21201-1009
3
NYU Langone Vaccine Center
New York, New York, United States, 10016
4
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States, 14642