Status:
COMPLETED
Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
PepTcell Limited
Conditions:
Mosquito-Borne Infectious Diseases
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
Detailed Description
This study will evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers. Participants will be randomly assigned to...
Eligibility Criteria
Inclusion
- 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 participant 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 below) 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:
- Of non-child bearing potential (i.e., women who have had a hysterectomy or tubal ligation, or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
- Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks before study initiation and 12 weeks after the second vaccine administration. Acceptable methods of contraception include a female partner who is the sole sexual partner of the female participant, a male partner who is sterile and is the sole sexual partner of the female participant, or a male partner who uses a condom with spermicide plus 1 or more of the following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of less than 1%; 4) oral contraceptives; and 5) double barrier method including diaphragm.
- Willing to have samples stored for future research.
- Agrees to abstain from alcohol intake for 24 hours before each study visit.
- Agrees to not donate blood or blood products throughout the study.
- Score greater than or equal to 70% on comprehension quiz at screening
Exclusion
- 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 or designee) baseline Grade 1 or greater toxicity, or any Grade 2 or greater toxicity (regardless of clinical significance) by the toxicity table.
- Receipt of blood or blood products including immunoglobulin within 3 months before enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) before enrollment.
- Receipt of any unlicensed vaccine within 6 months before enrollment.
- Participated in study NCT03055000 testing safety and immunogenicity of AGS-v.
- Self-reported or known history of alcoholism or drug abuse within 6 months before enrollment.
- Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI or designee 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 or designee, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent.
- Known allergy to any vaccine component, including adjuvants.
- History of severe immunization reaction.
- Severe allergic reaction to mosquito bites (anaphylaxis)
- Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days before study vaccination
- Have taken high-dose inhaled corticosteroids\* within 30 days before each study vaccination (\* High-dose defined per age as using inhaled high dose per reference chart: https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthma\_qrg\_0\_0.pdf)
- Received or plan to receive a licensed, live vaccine within 30 days before or after the study vaccination
- Received or plan to receive a licensed, inactivated vaccine within 14 days before or after study vaccination
- Serologic evidence of infection with HIV, hepatitis B virus, or hepatitis C virus
- Ongoing chronic skin condition, or acute skin condition at the time of vaccination or mosquito feeding, except for mild eczema.
- History of keloid formation after previous biopsies, lacerations, abrasions, surgeries, or other skin procedures (e.g., cosmetic piercings) that are deemed by the PI or designee to be a contraindication to protocol participation.
- Pregnancy, breastfeeding, or planning to become pregnant up to one month after mosquito feeding.
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04009824
Start Date
July 8 2019
End Date
February 23 2021
Last Update
April 28 2022
Active Locations (1)
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1
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States, 21201-1509