Trial Outcomes & Findings for Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer (NCT NCT02405221)
NCT ID: NCT02405221
Last Updated: 2026-01-29
Results Overview
Safety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Up to 24 months following the first dose of study vaccine
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
TA-CIN Administration Via Thigh
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
TA-CIN Administration Via Thigh
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
Baseline characteristics by cohort
| Measure |
TA-CIN Administration Via Thigh
n=8 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
n=7 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=35 Participants
|
58 years
n=4328 Participants
|
44 years
n=8687 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=35 Participants
|
7 Participants
n=4328 Participants
|
15 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=35 Participants
|
7 Participants
n=4328 Participants
|
14 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
9 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=35 Participants
|
7 Participants
n=4328 Participants
|
15 Participants
n=8687 Participants
|
|
Primary Site Disease
Cervix, NOS
|
4 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
7 Participants
n=8687 Participants
|
|
Primary Site Disease
Endocervix
|
4 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
|
Histology
Adenocarcinoma (ADC)
|
5 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Histology
Squamous cell (SCC)
|
3 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
|
Histology
Small cell carcinoma + ADC
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Histology Grade
Poorly differentiated
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Histology Grade
Moderately differentiated
|
3 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Histology Grade
Well-differentiated
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Histology Grade
Unknown/No comment
|
3 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Cervical Cancer Stage
IB
|
4 Participants
n=35 Participants
|
6 Participants
n=4328 Participants
|
10 Participants
n=8687 Participants
|
|
Cervical Cancer Stage
IIA/IIB
|
3 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Cervical Cancer Stage
IIIC
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Prior Treatment
Surgery only
|
3 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Prior Treatment
ChemoRadiation only
|
4 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
7 Participants
n=8687 Participants
|
|
Prior Treatment
Surgery + ChemoRadiation
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Prior Treatment
Surgery + Radiation
|
1 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Adjuvant Chemo Regimen
None
|
5 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
|
Adjuvant Chemo Regimen
Cisplatin
|
3 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Adjuvant Chemo Regimen
Cisplatin/Etoposide
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Adjuvant Radiation Site
No radiation
|
3 Participants
n=35 Participants
|
2 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Adjuvant Radiation Site
Cervix
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Adjuvant Radiation Site
Pelvis involved
|
2 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
6 Participants
n=8687 Participants
|
|
Adjuvant Radiation Site
Syed brachytherapy
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Months from end of prior treatment until first vaccination
|
6.5 months
n=35 Participants
|
8.4 months
n=4328 Participants
|
6.7 months
n=8687 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months following the first dose of study vaccineSafety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0.
Outcome measures
| Measure |
TA-CIN Administration Via Thigh
n=8 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
n=7 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
Treatment-related AEs
|
5 Participants
|
3 Participants
|
|
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
Treatment-emergent AEs
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: 1 excluded from efficacy cohort due to withdrawal secondary to toxicity
Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA).
Outcome measures
| Measure |
TA-CIN Administration Via Thigh
n=7 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
n=7 Participants
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood
E6-specific antibodies
|
0.32 absorbance units
Standard Deviation 0.32
|
0.17 absorbance units
Standard Deviation 0.17
|
|
Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood
L2-specific antibodies
|
1.03 absorbance units
Standard Deviation 0.70
|
1.27 absorbance units
Standard Deviation 0.92
|
|
Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood
E7-specific antibodies
|
0.91 absorbance units
Standard Deviation 0.97
|
0.66 absorbance units
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Lack of assay sensitivity for rare T cell populations. Data will not be collected or analyzed in the future.
Level of circulating HPV16 E6- and E7- specific CD8+ T cells and/or CD4+ T cells in the peripheral blood pre- and post-vaccination (visualized by ELISPOT)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Blood sample exhaustion. Data will not be collected or analyzed in the future.
Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 yearsLevels of circulating HPV16 E6- and E7-specific CD8+ T cells in the peripheral blood pre- and post-vaccination (measured using T-cell receptor sequencing)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 yearsLevels of HPV-specific neutralizing antibodies in the peripheral blood pre- and post-vaccination
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsResidual HPV16 viral load in plasma
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsClinical response associated with vaccine induced immune responses as measured by Time from administration of TA-CIN to disease recurrence.
Outcome measures
Outcome data not reported
Adverse Events
TA-CIN Administration Via Thigh
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
TA-CIN Administration Via Arm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-CIN Administration Via Thigh
n=8 participants at risk
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
n=7 participants at risk
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
Gastrointestinal disorders
Bowel obstruction (adhesion-related)
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
Other adverse events
| Measure |
TA-CIN Administration Via Thigh
n=8 participants at risk
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (thigh): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
TA-CIN Administration Via Arm
n=7 participants at risk
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
TA-CIN (arm): TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
|
|---|---|---|
|
General disorders
Injection site reaction
|
62.5%
5/8 • Number of events 5 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
42.9%
3/7 • Number of events 3 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Bloating
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
General disorders
General disorders-admin site condition-other
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Infections and infestations
Infections and infestations
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Investigations
Investigations
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Obstruction gastrointestinal
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
General disorders
Pain
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/8 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
14.3%
1/7 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
|
Eye disorders
Watering eyes
|
12.5%
1/8 • Number of events 1 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
0.00%
0/7 • Up to 24 months following the first dose of study vaccine
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate.
|
Additional Information
Stephanie Gaillard, MD, PhD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8240
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place