Trial Outcomes & Findings for Janssen Ad26.CoV2.S Vaccine Booster in Kidney Transplant Recipients (NCT NCT05220397)

NCT ID: NCT05220397

Last Updated: 2025-09-15

Results Overview

Number of patients with initial anti-COVID spike protein antibody levels \>0 but \<250U/ml at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

468 participants

Primary outcome timeframe

28 days following first dose of Janssen Ad26.CoV2.S vaccine

Results posted on

2025-09-15

Participant Flow

468 subjects enrolled in the study; 49 were excluded as they didn't provide a screening serum sample. 29 subjects were excluded as they withdrew consent.

Participant milestones

Participant milestones
Measure	Initial Responders Individuals who received the Pfizer or Moderna vaccines and had high levels of spike antibodies in their blood, received standard of care immunosuppressive (IS) medications.	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage
Initial Study Enrollment STARTED	335	22	13	12	8
Initial Study Enrollment COMPLETED	335	22	13	12	8
Initial Study Enrollment NOT COMPLETED	0	0	0	0	0
First Janssen Vaccine Administration STARTED	0	22	13	12	8
First Janssen Vaccine Administration COMPLETED	0	22	13	12	8
First Janssen Vaccine Administration NOT COMPLETED	0	0	0	0	0
Second Janssen Vaccine Administration STARTED	0	0	13	0	0
Second Janssen Vaccine Administration COMPLETED	0	0	5	0	0
Second Janssen Vaccine Administration NOT COMPLETED	0	0	8	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Initial Responders Individuals who received the Pfizer or Moderna vaccines and had high levels of spike antibodies in their blood, received standard of care immunosuppressive (IS) medications.	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage
Second Janssen Vaccine Administration Withdrawal by Subject	0	0	8	0	0

Baseline Characteristics

Janssen Ad26.CoV2.S Vaccine Booster in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Responders n=335 Participants Individuals who received the Pfizer or Moderna vaccines and had high levels of spike antibodies in their blood, received standard of care immunosuppressive (IS) medications.	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders n=22 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders n=13 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication n=12 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication n=8 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage	Total n=390 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 12.6 • n=5 Participants	62.7 years STANDARD_DEVIATION 11.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 9.6 • n=5 Participants	67.1 years STANDARD_DEVIATION 6.9 • n=4 Participants	63.4 years STANDARD_DEVIATION 7.8 • n=21 Participants	60.9 years STANDARD_DEVIATION 12.2 • n=8 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	145 Participants n=8 Participants
Sex: Female, Male Male	207 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	245 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	34 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	306 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	353 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	33 Participants n=8 Participants
Race (NIH/OMB) White	279 Participants n=5 Participants	22 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	326 Participants n=8 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=8 Participants
Region of Enrollment United States	335 participants n=5 Participants	22 participants n=7 Participants	13 participants n=5 Participants	12 participants n=4 Participants	8 participants n=21 Participants	390 participants n=8 Participants

PRIMARY outcome

Timeframe: 28 days following first dose of Janssen Ad26.CoV2.S vaccine

Outcome measures

Outcome measures
Measure	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders n=22 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders n=13 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Low Level Anti-COVID Spike Protein at Enrollment	22 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: 28 days following first dose of Janssen Ad26.CoV2.S vaccine

Number of patients with undetectable anti-COVID spike protein antibody level at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.

Outcome measures

Outcome measures
Measure	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders n=12 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders n=8 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Undetectable Anti-COVID Spike Protein at Enrollment	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 28 days after second dose of Janssen Ad26.CoV2.S vaccine, up to 2 months

Number of subjects to achieve an anti-COVID spike protein antibody level greater than or equal to 250 U/mL 28 days after a second dose with the Janssen Ad26.CoV2.S vaccine.

Outcome measures

Outcome measures
Measure	Low Levels (LL) Spike Antibodies: Janssen Vaccine Responders n=5 Participants Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Low Levels (LL) Spike Antibodies: Janssen Vaccine Non-Responders Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle	Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage	Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects Who Had Low or Undetectable Levels of Anti-COVID Spike Protein After the First Dose of the Janssen Vaccine	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Population: No data was collected or analyzed on any subject for durability of anti-COVID spike protein antibody levels at 2 years as the study was terminated early.

As measured by antibody levels from anti-COVID spike protein antibody tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: No data was collected or analyzed on any subject for incidence of COVID-19 infection at 2 years as the study was terminated early.

Number of subject infected with COVID-19 after enrollment. Criteria for suspected COVID includes: positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 OR New onset or worsening of any one of the following symptoms, which lasts for at least 24 hours, not otherwise explained: headache, malaise, myalgia, chest congestion, cough, runny nose, shortness of breath or difficulty breathing (resting or on exertion), sore throat, wheezing, eye irritation or discharge, chills, fever (≥ 38.0°C or ≥ 100.4°F), pulse oximetry value ≤95% (which is a decrease from baseline), heart rate ≥90 bpm at rest (which is an increase from baseline), GI symptoms, neurologic symptoms, red or bruised looking toes, skin rash, taste loss or new/changing sense of smell, symptoms of blood clots, confusion, bluish lips or face, clinical suspicion or judgement by sponsor-investigator of symptoms suggestive for COVID-19.