Trial Outcomes & Findings for Systems Biology of Zoster Vaccine (NCT NCT04047979)

Last Updated: 2024-07-30

Results Overview

Will be assessed between D0, D1, and D7 and each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts: 50-60 years and \>70 years of age. Results will be reported using Mean Normalized Enrichment Score (NES) of the Antiviral Interferon Signature Module (NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the score (less activity), and a positive score reflects more activity of the module).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Day 1 from Day 0, Day 7 from Day 0, Day 61 from day 60, Day 67 from day 60

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Younger Group Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Overall Study STARTED	30	8
Overall Study COMPLETED	18	8
Overall Study NOT COMPLETED	12	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Systems Biology of Zoster Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Younger Group n=30 Participants Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group n=8 Participants Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Total n=38 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 2.9 • n=5 Participants	71.0 years STANDARD_DEVIATION 1.2 • n=7 Participants	57.9 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	8 Participants n=7 Participants	38 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	6 Participants n=7 Participants	21 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	30 participants n=5 Participants	8 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 from Day 0, Day 7 from Day 0, Day 61 from day 60, Day 67 from day 60

Population: Population of the outcome differ per time point based on the Number of participants that completed each follow up.

Outcome measures

Outcome measures
Measure	Younger Group n=27 Participants Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group n=8 Participants Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Change in Innate Immune Signatures Post-vaccine Dose Innate Immune signature at Day 1 from Day 0	1.6801 Normalized Enrichment Score (NES) Standard Deviation 0.8987	2.096 Normalized Enrichment Score (NES) Standard Deviation 0.2983
Change in Innate Immune Signatures Post-vaccine Dose Innate Immune signature at Day 7 from Day 0	-0.5609 Normalized Enrichment Score (NES) Standard Deviation 1.3293	-1.1284 Normalized Enrichment Score (NES) Standard Deviation 1.1369
Change in Innate Immune Signatures Post-vaccine Dose Innate Immune signature at Day 61 from Day 60	2.096 Normalized Enrichment Score (NES) Standard Deviation 0.3645	1.9814 Normalized Enrichment Score (NES) Standard Deviation 1.1519
Change in Innate Immune Signatures Post-vaccine Dose Innate Immune signature at Day 67 from Day 60	-0.0081 Normalized Enrichment Score (NES) Standard Deviation 1.3921	-1.071 Normalized Enrichment Score (NES) Standard Deviation 1.1055

SECONDARY outcome

Timeframe: Day 270 post-intervention

Population: Population analyzed in this outcome includes participants that completed the last follow up at 270 days post-intervention.

Differences in related adverse events and serious adverse events between each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts. Number of participants with related AEs and SAEs (assessed within 7 days post-vaccination) will be reported.

Outcome measures

Outcome measures
Measure	Younger Group n=18 Participants Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group n=8 Participants Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Safety of Zoster Vaccine Recombinant, Adjuvanted Number of participants with AEs at Day 270 for First vaccine dose	4 Participants	0 Participants
Safety of Zoster Vaccine Recombinant, Adjuvanted Number of participants with SAEs at Day 270 for First vaccine dose	0 Participants	0 Participants
Safety of Zoster Vaccine Recombinant, Adjuvanted Number of participants with AEs at Day 270 for Second vaccine dose	1 Participants	0 Participants
Safety of Zoster Vaccine Recombinant, Adjuvanted Number of participants with SAEs at Day 270 for Second vaccine dose	0 Participants	0 Participants

Adverse Events

Younger Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Older Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Younger Group n=30 participants at risk Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group n=8 participants at risk Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Nervous system disorders Cerebrovascular ischemia	0.00% 0/30 • Throughout study duration, an average of 270 days.	12.5% 1/8 • Number of events 1 • Throughout study duration, an average of 270 days.
Infections and infestations West Nile Virus	0.00% 0/30 • Throughout study duration, an average of 270 days.	12.5% 1/8 • Number of events 1 • Throughout study duration, an average of 270 days.

Other adverse events

Other adverse events
Measure	Younger Group n=30 participants at risk Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.	Older Group n=8 participants at risk Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®) Shingrix®: A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
Nervous system disorders Peripheral Neuropathy	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
General disorders Vertigo	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	6.7% 2/30 • Number of events 2 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Skin and subcutaneous tissue disorders Itching	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Renal and urinary disorders Ureteroscopy with lithotripsy	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Cardiac disorders Hypertension emergency	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
General disorders Allergic rhinitis	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
General disorders Automobile accident	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.
Surgical and medical procedures Reconstructive surgery 3rd, 4th, 5th phalange	3.3% 1/30 • Number of events 1 • Throughout study duration, an average of 270 days.	0.00% 0/8 • Throughout study duration, an average of 270 days.

Additional Information

Dr. Nadine Rouphael

Emory University

Phone: 404-712-1435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place