Mosquito-Borne DiseasePhase 1NCT03055000
Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine
A Phase 1 study testing AGS-v and AGS-v + adjuvant in people with Mosquito-Borne Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mosquito-Borne Disease
- What is being tested?
- AGS-v and AGS-v + adjuvant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 28 Dec 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Participant has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the participation in the study.
- Individual with body mass index (BMI) less than or equal to 18 and greater than or equal to 40.
- Participants who have a clinically significant (as determined by the PI) baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
- Receipt of any unlicensed vaccine within 6 months prior to enrollment.
Show all 13Show fewer
- Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine/serum test for drugs of abuse at screening
- Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.
- History of a previous severe allergic reaction with generalized urticaria, angioedema, anaphylaxis or anaphylactoid reaction.
- Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent.
- Has a known allergy to any of the components of the vaccine.
- Has a history of severe immunization reaction.
- Has a severe allergic reaction to mosquito bites
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v, a Universal Mosquito-Borne Disease Vaccine
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Mosquito-Borne Disease
- Being tested
- AGS-v, AGS-v + adjuvant, Placebo
- Keywords
- Mosquito-Borne Diseases, Universal Mosquito Vaccine, Mosquito Transmission, Vector Borne Viruses, Vaccine
- Medical subject headings
- Mosquito-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-vBiological
AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21
AGS-v + adjuvantBiological
ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21
PlaceboOther
WFI (0.5mL) on Day 0 and Day 21
| Study group | Role | What they receive |
|---|---|---|
| AGS-v | Experimental | AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21 Receives: Biological: AGS-v |
| AGS-v with adjuvant | Experimental | ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL)on Day 0 and on Day 21 Receives: Biological: AGS-v + adjuvant |
| Placebo | Placebo comparator | WFI (0.5mL) on Day 0 and Day 21 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs Grade 3 or Higher
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 21 days after last vaccination
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
Measured: 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
Measured: 21 days after last vaccination
Number of Subjects With 1 or More Aes
Percent of people with an AE
Measured: 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
Measured: 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
Measured: 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.
Measured: 21 days after last vaccination
Secondary outcomes (14)
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
Measured: 60 days after Day 42 Mosquito Feeding
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 60 days after Day 42 Mosquito Feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start15 Feb 2017
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mosquito-Borne DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055000
- Sponsor's protocol ID
- 170059
- Other IDs
- 17-I-0059
- Status last verified
- Dec 2018
- First submitted
- 14 Feb 2017
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 8814051Sidjanski 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.
PubMed 9347958Ribeiro 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.
PubMed 2880553Manning 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.
PubMed 32534628
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v, a Universal Mosquito-Borne Disease Vaccine
- ClinicalTrials.gov ID
- NCT03055000
- Acronym / sponsor ID
- 170059
- Conditions
- Mosquito-Borne Disease
- Keywords
- Mosquito-Borne Diseases, Universal Mosquito Vaccine, Mosquito Transmission, Vector Borne Viruses, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGS-v | Experimental | Biological: AGS-vAGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21 |
| AGS-v with adjuvant | Experimental | Biological: AGS-v + adjuvantISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL)on Day 0 and on Day 21 |
| Placebo | Placebo comparator | Other: PlaceboWFI (0.5mL) on Day 0 and Day 21 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Participant has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the participation in the study.
- Individual with body mass index (BMI) less than or equal to 18 and greater than or equal to 40.
- Participants who have a clinically significant (as determined by the PI) baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-vAGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21 | Biological | AGS-v |
| AGS-v + adjuvantISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21 | Biological | AGS-v with adjuvant |
| PlaceboWFI (0.5mL) on Day 0 and Day 21 | Other | Placebo |
Primary outcome
AEs Grade 3 or Higher
Time frame: 1 year after vaccination (study duration)
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
GM-CSF Cytokine Level as Measured by Luminex
Time frame: 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
IL-10 Cytokine Level as Measured by Luminex
Time frame: 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
IL-1B Cytokine Level as Measured by Luminex
Time frame: 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
IL-2 Cytokine Level as Measured by Luminex
Time frame: 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
IL-4 Cytokine Level as Measured by Luminex
Time frame: 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
IL-5 Cytokine Level as Measured by Luminex
Time frame: 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
Interferon-gamma Cytokine Level as Measured by Luminex
Time frame: 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
Number of Subjects With 1 or More Aes
Time frame: 1 year after vaccination (study duration)
Percent of people with an AE
Number of Subjects With 1 or More Grade 3 or Higher AE
Time frame: 1 year after vaccination (study duration)
Percent of people with a Grade 3 or higher AE
TNF-a Cytokine Level as Measured by Luminex
Time frame: 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
Total AGS-v Specific Immunoglobulin
Time frame: 21 days after last vaccination
Total AGS-v specific immunoglobulin measured in serum 14 days after the first and/or second vaccination.
14 secondary outcomes
GM-CSF Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
IL-10 Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
IL-1B Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
IL-2 Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
IL-4 Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
IL-5 Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
Interferon-gamma Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
Number of Adults Developed From 100 Eggs
Time frame: Day 42 Mosquito feeding
Number of Eggs Laid
Time frame: Day 42 Mosquito feeding
Number of Pupae Hatched of 100 Eggs
Time frame: Day 42 Mosquito feeding
Percent of Eggs That Developed Into Pupae
Time frame: Day 42 Mosquito feeding
Percent of Pupae That Developed Into Adults
Time frame: Day 42 Mosquito feeding
TNF-a Cytokine Level as Measured by Luminex
Time frame: 60 days after Day 42 Mosquito Feeding
Total AGS-v Specific Immunoglobulin
Time frame: 60 days after Day 42 Mosquito Feeding
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8814051Peng 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.
- Background: PubMed 9347958Sidjanski 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.
- Background: PubMed 2880553Ribeiro 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.
- Derived from this study: PubMed 32534628Manning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGS-v and AGS-v + adjuvant in people with Mosquito-Borne Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs Grade 3 or Higher (time frame: 1 year after vaccination (study duration)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055000, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.