Trial Outcomes & Findings for Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults (NCT NCT02013687)
NCT ID: NCT02013687
Last Updated: 2017-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
336 days
Results posted on
2017-03-08
Participant Flow
Participant milestones
| Measure |
2 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
16
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
2 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Missed visits due to patient travel
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
2 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
36.8 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 6.59 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 8.86 • n=4 Participants
|
34.3 years
STANDARD_DEVIATION 8.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 336 daysOutcome measures
| Measure |
2 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Subjects With at Least One Adverse Event
|
4 Participants
|
4 Participants
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 336 daysOutcome measures
| Measure |
2 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Subjects With Solicited Systemic Adverse Events
|
2 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 336 daysOutcome measures
| Measure |
2 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Subjects With Solicited Local Adverse Events
|
4 Participants
|
6 Participants
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 196 daysPopulation: In the "30 µg + Alhydrogel" group, 15 out of 16 patient samples were analyzed as 1 patient in the group had withdrawn from the study by study day 196. In the "100 µg + Alhydrogel" group, 13 out of 16 patient samples were analyzed due to 2 patients in the group withdrawing from the study and an insufficient serum sample from a third patient.
Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Outcome measures
| Measure |
2 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
n=6 Participants
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=15 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=13 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Assessment of Anti-Pfs25 IgG Following the Third Immunization.
|
139.2 Antibody Titer
Interval 19.0 to 1018.0
|
511.2 Antibody Titer
Interval 79.5 to 3287.0
|
492.9 Antibody Titer
Interval 202.4 to 1200.0
|
996.0 Antibody Titer
Interval 510.0 to 1942.0
|
SECONDARY outcome
Timeframe: 84 daysAssessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.
Outcome measures
| Measure |
2 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=16 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=15 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
|
—
|
—
|
3.5 % TRA
Interval -106.4 to 54.7
|
4.3 % TRA
Interval -103.8 to 55.3
|
SECONDARY outcome
Timeframe: 196 daysAssessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.
Outcome measures
| Measure |
2 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
10 µg + Alhydrogel
Pfs25 VLP- FhCMB vaccine
|
30 µg + Alhydrogel
n=15 Participants
Pfs25 VLP- FhCMB vaccine
|
100 µg + Alhydrogel
n=13 Participants
Pfs25 VLP- FhCMB vaccine
|
|---|---|---|---|---|
|
Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
|
—
|
—
|
9.1 % TRA
Interval -92.1 to 56.9
|
22.5 % TRA
Interval -59.8 to 62.9
|
Adverse Events
2 µg + Alhydrogel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 µg + Alhydrogel
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
30 µg + Alhydrogel
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
100 µg + Alhydrogel
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 µg + Alhydrogel
n=6 participants at risk
Pfs25 VLP-FhCMB vaccine
|
10 µg + Alhydrogel
n=6 participants at risk
Pfs25 VLP-FhCMB vaccine
|
30 µg + Alhydrogel
n=16 participants at risk
Pfs25 VLP-FhCMB vaccine
|
100 µg + Alhydrogel
n=16 participants at risk
Pfs25 VLP-FhCMB vaccine
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast Abscess
|
0.00%
0/6 • 7 months
196 days
|
16.7%
1/6 • Number of events 1 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
|
Surgical and medical procedures
Foot Deformity
|
0.00%
0/6 • 7 months
196 days
|
0.00%
0/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
6.2%
1/16 • Number of events 1 • 7 months
196 days
|
Other adverse events
| Measure |
2 µg + Alhydrogel
n=6 participants at risk
Pfs25 VLP-FhCMB vaccine
|
10 µg + Alhydrogel
n=6 participants at risk
Pfs25 VLP-FhCMB vaccine
|
30 µg + Alhydrogel
n=16 participants at risk
Pfs25 VLP-FhCMB vaccine
|
100 µg + Alhydrogel
n=16 participants at risk
Pfs25 VLP-FhCMB vaccine
|
|---|---|---|---|---|
|
General disorders
Fatigue/Malaise
|
33.3%
2/6 • 7 months
196 days
|
33.3%
2/6 • 7 months
196 days
|
25.0%
4/16 • 7 months
196 days
|
37.5%
6/16 • 7 months
196 days
|
|
General disorders
Headache
|
0.00%
0/6 • 7 months
196 days
|
50.0%
3/6 • 7 months
196 days
|
31.2%
5/16 • 7 months
196 days
|
25.0%
4/16 • 7 months
196 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • 7 months
196 days
|
16.7%
1/6 • 7 months
196 days
|
6.2%
1/16 • 7 months
196 days
|
31.2%
5/16 • 7 months
196 days
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 7 months
196 days
|
16.7%
1/6 • 7 months
196 days
|
12.5%
2/16 • 7 months
196 days
|
25.0%
4/16 • 7 months
196 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/6 • 7 months
196 days
|
12.5%
2/16 • 7 months
196 days
|
18.8%
3/16 • 7 months
196 days
|
|
General disorders
Chills
|
33.3%
2/6 • 7 months
196 days
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
18.8%
3/16 • 7 months
196 days
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
18.8%
3/16 • 7 months
196 days
|
|
General disorders
Sweats
|
0.00%
0/6 • 7 months
196 days
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
12.5%
2/16 • 7 months
196 days
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
12.5%
2/16 • 7 months
196 days
|
|
General disorders
Fever
|
16.7%
1/6 • 7 months
196 days
|
0.00%
0/6 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
0.00%
0/16 • 7 months
196 days
|
Additional Information
Dr. Jessica Chichester, Senior Scientist Immunology
Fraunhofer USA Center for Molecular Biotechnology
Phone: 302-369-3635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In no event shall the PI publish or present, at any time, the data generated in the course of the performance of the study.
- Publication restrictions are in place
Restriction type: OTHER