Trial Outcomes & Findings for Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis (NCT NCT04475081)

NCT ID: NCT04475081

Last Updated: 2024-11-26

Results Overview

peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 50 participants
• Primary outcome timeframe: 30 days post vaccination
• Results posted on: 2024-11-26

Participant Flow

Participant milestones

Measure	MMR Vaccination Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Overall Study STARTED	25	25
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis

Baseline characteristics by cohort

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	51 years n=5 Participants	55 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post vaccination

Population: Myeloid-derived suppressor cells in blood

peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Induction of MDSCs	0.19 fold change compared to baseline Standard Deviation 0.19	0.11 fold change compared to baseline Standard Deviation 0.17

PRIMARY outcome

Timeframe: 60 days post vaccination

Population: Myeloid-derived suppressor cells in blood

peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Induction of MDSCs	0.19 fold change compared to baseline Standard Deviation 0.19	0.25 fold change compared to baseline Standard Deviation 0.25

PRIMARY outcome

Timeframe: 12 months post vaccination

Population: Myeloid-derived suppressor cells

peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Induction of MDSCs	0.09 fold change compared to baseline Standard Deviation 0.08	0.09 fold change compared to baseline Standard Deviation 0.12

SECONDARY outcome

Timeframe: 30 days post-vaccination

COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
COVID-19 Infection Positive	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days post-vaccination

Population: positive test for COVID-19 - antibodies or PCR

COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
COVID-19 Infection Positive	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months post-vaccination

Population: positive test for COVID-19 - antibodies or PCR

COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
COVID-19 Infection Positive	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 9 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 11 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months post-vaccination

Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Outcome measures

Measure	MMR Vaccination n=19 Participants Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 Participants Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Health Questionnaire	0 Participants	0 Participants

Adverse Events

MMR Vaccination

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	MMR Vaccination n=19 participants at risk Subjects will be randomized to receive the MMR Vaccine subcutaneously MMR vaccine: Merck MMR-II vaccine	Placebo Control n=15 participants at risk Subjects will be randomized to receive sterile saline given subcutaneously MMR vaccine: Merck MMR-II vaccine
Immune system disorders allergy	5.3% 1/19 • Number of events 1 • up to 72 h post-vaccination for any allergic responses. After 72 h allergic responses would not be evident. Any other monitoring for adverse events and conditions were monitored monthly through a 12-month enrollment period in the study allergic reactions to the vaccine were monitored by calls by nursing staff or reported back to nursing staff over a 72 h period post-vaccination. Any other adverse events, treatment or non-treatment, were monitored by the nursing staff via monthly phone calls. Adverse events could have been any type of sickness, including COVID. Any adverse events would be recorded and documented, but only those related to COVID would be part of the results obtained and used in the analyses.	0.00% 0/15 • up to 72 h post-vaccination for any allergic responses. After 72 h allergic responses would not be evident. Any other monitoring for adverse events and conditions were monitored monthly through a 12-month enrollment period in the study allergic reactions to the vaccine were monitored by calls by nursing staff or reported back to nursing staff over a 72 h period post-vaccination. Any other adverse events, treatment or non-treatment, were monitored by the nursing staff via monthly phone calls. Adverse events could have been any type of sickness, including COVID. Any adverse events would be recorded and documented, but only those related to COVID would be part of the results obtained and used in the analyses.

Other adverse events

Adverse event data not reported

Additional Information

Associate Dean for Research

Louisiana State University Health - New Orleans

Phone: 9858693445

Email: pfidel@lsuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place