Trial Outcomes & Findings for An Open Label Study of IgG Fc Glycan Composition in Human Immunity (NCT NCT01967238)

NCT ID: NCT01967238

Last Updated: 2024-09-19

Results Overview

The percent of Fc glycans that are galactosylation, fucosylation and/or sialylation of pre- vs. post- vaccination Fcs determined by lectin blot (Erythrina cristagalli, Aleuria Aurantia Lectin and Sambucus nigra lectins specific for galactose, fucose and 2,6-sialic acid, respectively) or by mass spectrometric analysis. 100% of IgG were found to have these modifications.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

129 participants

Primary outcome timeframe

One Day

Results posted on

2024-09-19

Participant Flow

3 study arms were intended, as described here.

129 participants were consented; 38 were not assigned to an arm because they screened out

Participant milestones

Participant milestones
Measure	Biologic/Vaccine, Age 18-64 Cohort Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Biologic/Vaccine, Age 65-80 Cohort Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Vaccine, Healthy Adults Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines
Overall Study STARTED	53	22	16
Overall Study COMPLETED	51	21	14
Overall Study NOT COMPLETED	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Biologic/Vaccine, Age 18-64 Cohort Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Biologic/Vaccine, Age 65-80 Cohort Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Vaccine, Healthy Adults Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines
Overall Study Adverse Event	1	1	0
Overall Study Lost to Follow-up	1	0	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

An Open Label Study of IgG Fc Glycan Composition in Human Immunity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biologic/Vaccine, Age 18-64 Cohort n=53 Participants Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Biologic/Vaccine, Age 65-80 Cohort n=22 Participants Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Vaccine, Healthy Adults n=16 Participants Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Total n=91 Participants Total of all reporting groups
Age, Customized >18 and < 65 years	53 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	68 Participants n=4 Participants
Age, Customized >= 65 and <= 80 years	0 Participants n=5 Participants	22 Participants n=7 Participants	1 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment United States	53 participants n=5 Participants	22 participants n=7 Participants	16 participants n=5 Participants	91 participants n=4 Participants

PRIMARY outcome

Timeframe: One Day

Population: The primary assessment in the study was intended to compare data for each Arm as shown with no comparisons by vaccine. All groups within Arm 1 were not fully enrolled, therefore it was adequately powered to perform analyses (data were not collected). Arm 2 was not fully enrolled and underpowered (data were not collected). Samples from Arm 3 were destroyed during the COVID-19 pandemic due to a stalled shipment which caused the samples to thaw for several days (data were not collected).

Outcome measures

Outcome measures
Measure	Biologic/Vaccine, Age 18-64 Cohort n=30 Participants Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Biologic/Vaccine, Age 65-80 Cohort Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines	Vaccine, Healthy Adults Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines
The Percent (of 100%) of IgG With Galactosylation, Fucosylation and/or Sialylation	100 % of glycosylated IgG	—	—

Adverse Events

Biologic/Vaccine, Age 18-64 Cohort

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Biologic/Vaccine, Age 65-80 Cohort

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vaccine, Healthy Adults

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Biologic/Vaccine, Age 18-64 Cohort n=53 participants at risk Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	Biologic/Vaccine, Age 65-80 Cohort n=22 participants at risk Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	Vaccine, Healthy Adults n=16 participants at risk Vaccination. IM Pneumococcal, meningococcal, or flu vaccine IM Pneumococcal, meningococcal, or flu vaccine: Volunteers given one of the 3 vaccines Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.
Infections and infestations Upper respiratory tract infection	5.7% 3/53 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	4.5% 1/22 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	0.00% 0/16 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.
Musculoskeletal and connective tissue disorders Stiffness	0.00% 0/53 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	4.5% 1/22 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	6.2% 1/16 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.
Immune system disorders Decreased white blood cell count	1.9% 1/53 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	0.00% 0/22 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	0.00% 0/16 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.
Immune system disorders Shingles	0.00% 0/53 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	0.00% 0/22 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	6.2% 1/16 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.
Gastrointestinal disorders Abdominal pain	0.00% 0/53 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	0.00% 0/22 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.	6.2% 1/16 • 3 years was the intended period over which each participant would be assessed. Adverse Events were monitored/assessed and collected by study cohort and not by vaccine type administered.

Additional Information

Taia Wang

Stanford University

Phone: 5103873941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place