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Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02013687
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : January 18, 2017
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Fraunhofer, Center for Molecular Biotechnology

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malaria
Intervention Biological: Pfs25 VLP- FhCMB
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine
Period Title: Overall Study
Started 6 6 16 16
Completed 6 6 14 14
Not Completed 0 0 2 2
Reason Not Completed
Lost to Follow-up             0             0             1             0
Protocol Violation             0             0             0             1
Withdrawal by Subject             0             0             0             1
Missed visits due to patient travel             0             0             1             0
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel Total
Hide Arm/Group Description Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine Pfs25 VLP- FhCMB vaccine Total of all reporting groups
Overall Number of Baseline Participants 6 6 16 16 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 16 participants 16 participants 44 participants
36.8  (8.93) 36.7  (6.59) 36.1  (8.96) 30.6  (8.86) 34.3  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 16 participants 16 participants 44 participants
Female
3
  50.0%
3
  50.0%
7
  43.8%
5
  31.3%
18
  40.9%
Male
3
  50.0%
3
  50.0%
9
  56.3%
11
  68.8%
26
  59.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 16 participants 16 participants 44 participants
Hispanic or Latino
2
  33.3%
1
  16.7%
1
   6.3%
1
   6.3%
5
  11.4%
Not Hispanic or Latino
4
  66.7%
5
  83.3%
15
  93.8%
14
  87.5%
38
  86.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
1
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 16 participants 16 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  66.7%
3
  50.0%
10
  62.5%
11
  68.8%
28
  63.6%
White
2
  33.3%
2
  33.3%
6
  37.5%
5
  31.3%
15
  34.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Subjects With at Least One Adverse Event
Hide Description [Not Specified]
Time Frame 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Overall Number of Participants Analyzed 6 6 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
4
  66.7%
11
  68.8%
15
  93.8%
2.Primary Outcome
Title Subjects With Solicited Systemic Adverse Events
Hide Description [Not Specified]
Time Frame 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Overall Number of Participants Analyzed 6 6 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
4
  66.7%
8
  50.0%
10
  62.5%
3.Primary Outcome
Title Subjects With Solicited Local Adverse Events
Hide Description [Not Specified]
Time Frame 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Pfs25 VLP- FhCMB vaccine
Overall Number of Participants Analyzed 6 6 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
6
 100.0%
12
  75.0%
15
  93.8%
4.Secondary Outcome
Title Assessment of Anti-Pfs25 IgG Following the Third Immunization.
Hide Description Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.
Time Frame 196 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Overall Number of Participants Analyzed 6 6 15 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: Antibody Titer
139.2
(19.0 to 1018)
511.2
(79.5 to 3287)
492.9
(202.4 to 1200)
996.0
(510.0 to 1942)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 30 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance of IgG values at study day 196 as compared to day 0 (pre-immune).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance of IgG values at study day 196 as compared to day 0 (pre-immune).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Hide Description Assessment 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.
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Overall Number of Participants Analyzed 0 0 16 15
Mean (95% Confidence Interval)
Unit of Measure: % TRA
3.5
(-106.4 to 54.7)
4.3
(-103.8 to 55.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 30 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite
Hide Description Assessment 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.
Time Frame 196 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description:
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Pfs25 VLP-FhCMB vaccine
Overall Number of Participants Analyzed 0 0 15 13
Mean (95% Confidence Interval)
Unit of Measure: % TRA
9.1
(-92.1 to 56.9)
22.5
(-59.8 to 62.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 30 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 µg + Alhydrogel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 7 months
Adverse Event Reporting Description 196 days
 
Arm/Group Title 2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Hide Arm/Group Description Pfs25 VLP-FhCMB vaccine Pfs25 VLP-FhCMB vaccine Pfs25 VLP-FhCMB vaccine Pfs25 VLP-FhCMB vaccine
All-Cause Mortality
2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/6 (16.67%)      0/16 (0.00%)      1/16 (6.25%)    
Reproductive system and breast disorders         
Breast Abscess   0/6 (0.00%)  0 1/6 (16.67%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0
Surgical and medical procedures         
Foot Deformity   0/6 (0.00%)  0 0/6 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2 µg + Alhydrogel 10 µg + Alhydrogel 30 µg + Alhydrogel 100 µg + Alhydrogel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      4/6 (66.67%)      8/16 (50.00%)      10/16 (62.50%)    
Gastrointestinal disorders         
Nausea   1/6 (16.67%)  1/6 (16.67%)  2/16 (12.50%)  4/16 (25.00%) 
Diarrhea   1/6 (16.67%)  0/6 (0.00%)  0/16 (0.00%)  3/16 (18.75%) 
Vomiting   1/6 (16.67%)  0/6 (0.00%)  0/16 (0.00%)  2/16 (12.50%) 
General disorders         
Fatigue/Malaise   2/6 (33.33%)  2/6 (33.33%)  4/16 (25.00%)  6/16 (37.50%) 
Headache   0/6 (0.00%)  3/6 (50.00%)  5/16 (31.25%)  4/16 (25.00%) 
Chills   2/6 (33.33%)  1/6 (16.67%)  0/16 (0.00%)  3/16 (18.75%) 
Sweats   0/6 (0.00%)  1/6 (16.67%)  0/16 (0.00%)  2/16 (12.50%) 
Fever   1/6 (16.67%)  0/6 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia   2/6 (33.33%)  1/6 (16.67%)  1/16 (6.25%)  5/16 (31.25%) 
Arthralgia   1/6 (16.67%)  0/6 (0.00%)  2/16 (12.50%)  3/16 (18.75%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In no event shall the PI publish or present, at any time, the data generated in the course of the performance of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Chichester, Senior Scientist Immunology
Organization: Fraunhofer USA Center for Molecular Biotechnology
Phone: 302-369-3635
EMail: jessica.chichester@fhcmb.org
Layout table for additonal information
Responsible Party: Fraunhofer, Center for Molecular Biotechnology
ClinicalTrials.gov Identifier: NCT02013687    
Other Study ID Numbers: FhCMB Pfs25-001
First Submitted: November 25, 2013
First Posted: December 17, 2013
Results First Submitted: November 21, 2016
Results First Posted: January 18, 2017
Last Update Posted: March 8, 2017