Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 17-I-0059 | Other Identifier | NIAID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background:
Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.
Objective:
To see if the AGS-v vaccine is safe in humans and how it affects the immune system.
Eligibility:
Healthy adults ages 18-50
Design:
Participants will be screened another study.
Participants will be randomly assigned to get either the vaccine with a booster vaccine, the vaccine without the booster, or a placebo. These are given through a needle in the upper arm.
Participants will have visits that include medical history, physical exam, and blood and urine tests:
Baseline: They will get the vaccine and be monitored for 2 hours.
Follow-up visits 1 and 2 weeks after baseline.
Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.
Follow-up visits 1 and 2 weeks after booster visit.
Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the feeding.
Phone follow-up a few days after the mosquito feeding.
After the feeding visit, 5 follow-up visits about every 2 months
Participants will keep a symptom diary for 7 days after each vaccine. They will record their temperature. They will measure any redness around the injection site. They will document and if possible photograph any mosquito bites they get.
Mosquito-borne diseases continue to cause significant morbidity and mortality worldwide despite on-going control efforts. In 2015, there were >200 million cases of malaria worldwide, causing nearly half a million deaths, with most of the deaths occurring among children under the age of 5 years. Mosquitos also transmit arboviruses, including dengue, yellow fever, West Nile virus, chikungunya, Rift Valley fever, Japanese encephalitis, and Zika virus. The current new outbreak of Zika virus in Central and South America, as well as the Caribbean, serves as a reminder of how quickly these viruses can spread and how difficult they can be to control.
In this protocol we plan to perform a Phase I study of a novel universal mosquito-borne disease vaccine. Through modulation of the immune system after a mosquito feeding, this vaccine targets the vector saliva and may provide prophylaxis against multiple arboviral and protozoal diseases. In addition the vaccine potentially leads to a reduced mosquito lifespan after feeding therefore also reducing transmission of these diseases.
In this protocol we hope to demonstrate the safety of this vaccine similar to SEEK s other peptide based vaccines Flu-v and HIV-v that have been found to have very good safety profiles in previous Phase I trials. We also hope to demonstrate immunomodulation after a controlled clean Aedes aegypti mosquito feeding to demonstrate proof of concept efficacy of the vaccine. With the current rise of Zika in the Americas and the threat of local mosquito transmission in the U.S. and the rest of the world, a successful universal mosquito-borne disease vaccine offers the benefit of targeting this emerging disease as well as the many established infections such as dengue and malaria that make dealing with this newly emerging epidemic a challenge.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGS-v | Experimental | AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21 |
|
| AGS-v with adjuvant | Experimental | ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL)on Day 0 and on Day 21 |
|
| Placebo | Placebo Comparator | WFI (0.5mL) on Day 0 and Day 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGS-v | Biological | AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AEs Grade 3 or Higher | Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart. | 1 year after vaccination (study duration) |
| GM-CSF Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| IL-10 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| IL-1B Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| IL-2 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| IL-4 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GM-CSF Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| IL-10 Cytokine Level as Measured by Luminex |
Not provided
-INCLUSION CRITERIA:
Healthy women and men who are greater than or equal to 18 and less than or equal to 50 years of age.
Willingness to complete all study visits and comply with all study requirements.
A male subject is eligible for the study if he agrees to practicing abstinence or using a condom with spermicide plus an acceptable form of contraception (see inclusion criteria 4) being used by any female partner from 4 weeks before study start to 12 weeks after the second vaccine administration.
A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
Willing to have samples stored for future research (including genetic research).
Agrees to abstain from alcohol intake for 24 hours prior to each study visit.
Agrees to not donate blood or blood products throughout the study.
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew J Memoli, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8814051 | Background | Peng Z, Yang M, Simons FE. Immunologic mechanisms in mosquito allergy: correlation of skin reactions with specific IgE and IgG antibodies and lymphocyte proliferation response to mosquito antigens. Ann Allergy Asthma Immunol. 1996 Sep;77(3):238-44. doi: 10.1016/S1081-1206(10)63262-0. | |
| 9347958 | Background | Sidjanski S, Vanderberg JP. Delayed migration of Plasmodium sporozoites from the mosquito bite site to the blood. Am J Trop Med Hyg. 1997 Oct;57(4):426-9. doi: 10.4269/ajtmh.1997.57.426. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AGS-v | 825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart |
| FG001 | AGS-v With Adjuvant | 825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses givemn 21 days apart |
| FG002 | Placebo | Placebo 2 doses given 21 days apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AGS-v | 825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart |
| BG001 | AGS-v With Adjuvant | 825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AEs Grade 3 or Higher | Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart. | All subjects who received vaccination | Posted | Mean | 95% Confidence Interval | adverse events | 1 year after vaccination (study duration) |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGS-v | 825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Memoli, Matthew | National Institute of Allergy and Infectious Diseases | +1 301 443 5971 | mm982v@nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2018 | Mar 4, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2018 | Mar 4, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| ID | Term |
|---|---|
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AGS-v + adjuvant |
| Biological |
ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21 |
|
| Placebo | Other | WFI (0.5mL) on Day 0 and Day 21 |
|
| IL-5 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| Interferon-gamma Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| Number of Subjects With 1 or More Aes | Percent of people with an AE | 1 year after vaccination (study duration) |
| Number of Subjects With 1 or More Grade 3 or Higher AE | Percent of people with a Grade 3 or higher AE | 1 year after vaccination (study duration) |
| TNF-a Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 21 days after last vaccination |
| Total AGS-v Specific Immunoglobulin | Total AGS-v specific immunoglobulin measured in serum 14 days after the first and/or second vaccination. | 21 days after last vaccination |
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response |
| 60 days after Day 42 Mosquito Feeding |
| IL-1B Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| IL-2 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| IL-4 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| IL-5 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| Interferon-gamma Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| Number of Adults Developed From 100 Eggs | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | Day 42 Mosquito feeding |
| Number of Eggs Laid | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | Day 42 Mosquito feeding |
| Number of Pupae Hatched of 100 Eggs | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | Day 42 Mosquito feeding |
| Percent of Eggs That Developed Into Pupae | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | Day 42 Mosquito feeding |
| Percent of Pupae That Developed Into Adults | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | Day 42 Mosquito feeding |
| TNF-a Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | 60 days after Day 42 Mosquito Feeding |
| Total AGS-v Specific Immunoglobulin | Total AGS-v specific immunoglobulin measured in serum after the first and/or second vaccination. | 60 days after Day 42 Mosquito Feeding |
| 2880553 | Background | Ribeiro JM. Role of saliva in blood-feeding by arthropods. Annu Rev Entomol. 1987;32:463-78. doi: 10.1146/annurev.en.32.010187.002335. No abstract available. |
| 32534628 | Derived | Manning JE, Oliveira F, Coutinho-Abreu IV, Herbert S, Meneses C, Kamhawi S, Baus HA, Han A, Czajkowski L, Rosas LA, Cervantes-Medina A, Athota R, Reed S, Mateja A, Hunsberger S, James E, Pleguezuelos O, Stoloff G, Valenzuela JG, Memoli MJ. Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial. Lancet. 2020 Jun 27;395(10242):1998-2007. doi: 10.1016/S0140-6736(20)31048-5. Epub 2020 Jun 11. |
| BG002 | Placebo | Placebo 2 doses given 21 days apart |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo 2 doses given 21 days apart |
|
|
| Primary | GM-CSF Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | IL-10 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | IL-1B Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | IL-2 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | IL-4 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | IL-5 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | Interferon-gamma Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | Number of Subjects With 1 or More Aes | Percent of people with an AE | All subjects who received vaccination | Posted | Count of Participants | Participants | 1 year after vaccination (study duration) |
|
|
|
| Primary | Number of Subjects With 1 or More Grade 3 or Higher AE | Percent of people with a Grade 3 or higher AE | All subjects who received vaccination | Posted | Count of Participants | Participants | 1 year after vaccination (study duration) |
|
|
|
| Primary | TNF-a Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 21 days after last vaccination |
|
|
|
| Primary | Total AGS-v Specific Immunoglobulin | Total AGS-v specific immunoglobulin measured in serum 14 days after the first and/or second vaccination. | All subjects who received vaccination | Posted | Mean | Standard Deviation | IU/mL | 21 days after last vaccination |
|
|
|
| Secondary | GM-CSF Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | IL-10 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | IL-1B Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | IL-2 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | IL-4 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | IL-5 Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | Interferon-gamma Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | Number of Adults Developed From 100 Eggs | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | All subjects who received vaccination | Posted | Mean | Standard Deviation | Adult aedes aegypti mosquitoes | Day 42 Mosquito feeding |
|
|
|
| Secondary | Number of Eggs Laid | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | All subjects who received vaccination | Posted | Mean | Standard Deviation | Eggs | Day 42 Mosquito feeding |
|
|
|
| Secondary | Number of Pupae Hatched of 100 Eggs | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | All subjects who received vaccination | Posted | Mean | Standard Deviation | Number of hatched pupae | Day 42 Mosquito feeding |
|
|
|
| Secondary | Percent of Eggs That Developed Into Pupae | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | All subjects who received vaccination | Posted | Mean | Standard Deviation | percentage of eggs | Day 42 Mosquito feeding |
|
|
|
| Secondary | Percent of Pupae That Developed Into Adults | Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination | All subjects who received vaccination | Posted | Mean | Standard Deviation | percentage of pupae | Day 42 Mosquito feeding |
|
|
|
| Secondary | TNF-a Cytokine Level as Measured by Luminex | Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response | All subjects who received vaccination | Posted | Mean | Standard Deviation | pg/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| Secondary | Total AGS-v Specific Immunoglobulin | Total AGS-v specific immunoglobulin measured in serum after the first and/or second vaccination. | All subjects who received vaccination | Posted | Mean | Standard Deviation | IU/mL | 60 days after Day 42 Mosquito Feeding |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 16 |
| 16 |
| EG001 | AGS-v With Adjuvant | 825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart | 0 | 17 | 0 | 17 | 17 | 17 |
| EG002 | Placebo | Placebo 2 doses given 21 days apart | 0 | 16 | 0 | 16 | 15 | 16 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site induration | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Tenderness | General disorders | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | Systematic Assessment |
|
| Campylobacter infection | Infections and infestations | Systematic Assessment |
|
| Hordeolum | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Laryngitis | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Blood urea increased | Investigations | Systematic Assessment |
|
| Eosinophil count increased | Investigations | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| White blood cells urine positive | Investigations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Systolic hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided