Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome (NCT NCT02996448)

NCT ID: NCT02996448

Last Updated: 2020-06-30

Results Overview

Antibody titer

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 2 weeks after vaccination
• Results posted on: 2020-06-30

Participant Flow

Healthy volunteers were not enrolled to the study due to the early termination. The three subjects enrolled were those with AD-HIES.

Participant milestones

Measure	Vaccination Group, Single Arm Study Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Vaccination Group, Single Arm Study Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.

Overall Study Study terminated due to adverse effects

3

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome

Baseline characteristics by cohort

Measure	Vaccination Group- Single Arm Study n=3 Participants Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.
Age, Continuous	20 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after vaccination

Population: As study was stopped prematurely due to safety concerns, the data was not obtained.

Antibody titer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Outcome measures

Measure

Vaccine Recipients n=3 Participants Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.

Number of Participants With Serious Adverse Events That Led to Study Termination.

1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Data were not collected due to premature termination of study.

Outcome measures

Outcome data not reported

Adverse Events

Vaccination Group- Single Arm Study

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure

Vaccination Group- Single Arm Study n=3 participants at risk Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.

Immune system disorders Anaphylaxis

33.3% 1/3 • Up to 6 months

Other adverse events

Measure	Vaccination Group- Single Arm Study n=3 participants at risk Participants will receive a single dose of 0.5 mL (300 micrograms of rAls3) administered via IM injection. NDV-3A: A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.
Musculoskeletal and connective tissue disorders Injection site pain	33.3% 1/3 • Number of events 1 • Up to 6 months
Gastrointestinal disorders Nausea	33.3% 1/3 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Up to 6 months
Nervous system disorders Dizziness	33.3% 1/3 • Up to 6 months
Nervous system disorders fatigue	33.3% 1/3 • Up to 6 months
Skin and subcutaneous tissue disorders Eczema exacerbation	66.7% 2/3 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	33.3% 1/3 • Up to 6 months

Additional Information

Alexandra Freeman

NIAID, NIH

Phone: 301-594-9045

Email: freemaal@mail.nih.gov

Results disclosure agreements

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